Temperature Modulation of Cryoanalgesia for Pain Control in Irreversible Pulpitis: a randomized clinical trial 

Temperature Modulation of Cryoanalgesia for Pain Control in Irreversible Pulpitis: a randomized clinical trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Temperature Modulation of Cryoanalgesia for Pain Control in Irreversible Pulpitis: a randomized clinical trial Gonzalo Gomez This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5460715/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objetives: This prospective, randomized clinical trial aimed to evaluate the efficacy of pulpal anesthesia in pain control during endodontic procedures by comparing administration of 3% mepivacaine at refrigerated temperature to 3% mepivacaine at room temperature in teeth diagnosed with irreversible pulpitis. The null hypothesis posited no difference between the two types of this local anesthetic. Materials and Methods: Twenty-six patients diagnosed with irreversible pulpitis of teeth were randomly distributed in two groups. Group 1 received 3% mepivacaine at room temperature, while Group 2 received 3% mepivacaine at 5°C. Preoperative variables were assessed, including pulp and periapical diagnosis, tooth type, pain levels, and anxiety level. Following administration of 3.6ml of local anesthesia, treatment commenced. Pain experienced during injection and pulpectomy were recorded. Fisher's exact test was employed to analyze preoperative factors and anesthetic success, with statistical significance set at p<0.05. Results: The study findings revealed statistical differences in the success rate of anesthesia between the two groups. Group 2, which received mepivacaine at 5°C, exhibited an 80% higher success rate than Group I, which received mepivacaine at room temperature (20%). None of the preoperative variables demonstrated a significant correlation with anesthetic success. Conclusion: Within the constraints of this clinical trial, it can be inferred that lowering the temperature of plain 3% mepivacaine from room temperature to 5°C enhances the success rate in pain management during treatment. Clinical Relevance This article reports on a randomized clinical trial demonstrating that cooling 3% mepivacaine to 5°C significantly improves anesthetic success and pain management in cases of irreversible pulpitis during endodontic procedures. Cryoanalgesia Irreversible Pulpitis Temperature Modulation Pain Management Cold Therapy Local Anesthesia. Figures Figure 1 Figure 2 Introduction In endodontics, effective anesthesia is crucial for both patient comfort and the efficiency of the clinical procedure. Anesthesia inadequacy not only heightens patient fear and anxiety but also extends treatment duration, thereby potentially tarnishing the clinician's reputation and undermining confidence in endodontic care (1). The efficacy of anesthesia depends on several factors, including the chosen technique and anatomical nuances associated with the inferior alveolar nerve (IAN) in lower molars (2, 3). Moreover, the inflammatory process within the pulp can significantly impede anesthetic efficacy. The clinician's principal choice for mandibular molars is the inferior alveolar nerve block (IANB). However, its success rates reduce in the presence of pulpal inflammation, ranging from approximately 20–70% (4). Conversely, buccal infiltration is the standard technique for maxillary molars. Nevertheless, its efficacy diminishes in teeth afflicted with symptomatic irreversible pulpitis, with failure rates ranging from 28–47% (5). Supplemental techniques such as buccal infiltration in mandibular molars, periodontal ligament injection, intraosseous anesthesia, and oral premedication have been proposed to bolster anesthesia success rates (6). Anatomical considerations significantly influence anesthesia success, with mandibular posterior teeth exhibiting markedly higher rates of anesthesia failure compared to other teeth (7). Furthermore, alterations in pulp characteristics induced by inflammatory processes precipitate anesthetic failure (4), while inflammation-induced vasodilation can expedite systemic absorption, thereby diminishing the concentration of local anesthetics (8). The choice of anesthetic solution is also crucial to anesthesia success. Among the array of options in dentistry, lidocaine and 4% articaine stand out as common choices. A systematic review revealed that 4% articaine (with 1:100,000 epinephrine) outperformed lidocaine (2% with 1:100,000 epinephrine) (5) in posterior teeth with inflamed pulps necessitating root canal therapy. However, retrospective studies have hinted at a higher risk of paresthesia linked with articaine (9,10). While a systematic review concluded that articaine could be safe, it underscored limitations in study quality, result consistency, and data precision, which could impinge on the robustness of inferences drawn from systematic reviews. Moreover, selection bias, inherent in all systematic reviews, remains a persistent challenge (11). Another noteworthy anesthetic solution is mepivacaine, available in either 2% concentration with vasoconstrictor or 3% without vasoconstrictor. Mepivacaine boasts favorable chemical properties, including a lower pKa and reduced vasodilation, culminating in prolonged anesthesia duration. Consequently, it is a potentially suitable option for pediatric patients and individuals with systemic disorders (2, 12). Studies comparing mepivacaine to lidocaine have demonstrated no disparities in anesthetic efficacy (5, 11). Despite extensive research efforts, achieving complete pulpal anesthesia in cases of irreversible pulpitis has remained elusive, prompting endeavors to identify optimal pain management strategies during endodontic procedures (5). Cryoanalgesia has emerged as an effective method of pain management in medical practice. By inducing temperature reduction and vasoconstriction, cold application leads to a decrease in tissue metabolites, inflammatory mediators, and neuropeptides (1). Previous research into cryoanalgesia has yielded promising results. For example, it has been shown that cold refrigerated lignocaine significantly improves anesthetic efficacy compared to lignocaine at room temperature, achieving an 86.6% success rate for maxillary first molars in irreversible pulpitis (13). Similarly, another study comparing cold refrigerated mepivacaine with room temperature mepivacaine in healthy maxillary first premolars revealed no significant differences in the onset of pulp anesthesia; however, cold refrigerated mepivacaine exhibited a longer duration of action (14). No prior research appears to have explored the influence of temperature on the action of 3% mepivacaine in irreversible pulpitis. Therefore, the present study aimed to assess the efficacy of cold refrigerated 3% mepivacaine compared to 3% mepivacaine at room temperature in teeth diagnosed with irreversible pulpitis. The null hypothesis posited no difference between the two types of this local anesthetic. Materials and Methods Ethical approval The trial was registered in ClinicalTrials.gov registry (ID: NCT06268912). This randomized clinical trial has been written approved by the Ethics in Human Research Committee (END-ECL-2022-01) and conducted from September 2022 to May 2023. The trial was registered on ClinicalTrials.gov (ID: NCT06268912) and has been written according CONSORTS 2010 guidelines. Study design and clinical data collection A total of 26 participants were enrolled, inclusion criteria were healthy individuals classified according to the American Society of Anesthesiologists ASA I-II, aged between 18 and 60 years, presenting with irreversible pulpitis. Exclusion criteria were (ASA III-VI), pregnant or lactating individuals, those with known allergies or sensitivities to study substances, pulp necrosis, ongoing treatment, acute or chronic apical abscess, non-restorable teeth, and cases of unsuccessful anesthesia techniques (absence of lip numbness for lower molars or positive response to cold test). Participants were diagnosed with irreversible pulpitis in molar teeth, adhering to specific inclusion and exclusion criteria. Detailed written and verbal information about the study was provided, and participants gave written informed consent. Diagnosis of irreversible pulpitis followed the American Association of Endodontics guidelines, characterized by sharp pain upon thermal stimuli, lingering pain (often exceeding 30 seconds after stimulus removal), spontaneous or unprovoked pain, and referred pain. Subsequently, participants rated their preoperative pain and anxiety using the Heft-Parker Visual Analog Scale (VAS). Anxiety Levels on the one VAS were categorized into four sections: no anxiety (0 mm), mild anxiety (>zero to ≤54mm, moderate anxiety >54 mm to <114 mm), and severe anxiety (≥ 114). Preoperative pain levels were similarly measured. Participants were randomly assigned to one of two groups, with 13 patients each group: Group 1 received 3% mepivacaine at room temperature, and Group 2 received 3% mepivacaine at 5ºC. The same clinician (J.T.), a final-year resident, performed all treatment procedures. Anesthetics administered using a self-aspirating syringe with a 25 mm 30-gauge needle. For maxillary teeth, buccal and palatal infiltration was performed, while for lower molars, the inferior alveolar nerve block (IANB) and buccal infiltration were administered. The first cartridge was administered over approximately 2 minutes, and the second buccal infiltration was administered either for maxillary teeth or mandibular teeth with 1 cartridge of 1.8ml. A blood aspiration test was conducted for each anesthetic injection. The total dose of anesthetic solution administered before treatment initiation was 3.6 ml. Ten minutes post-initial anesthesia, lip numbness (specifically for lower teeth) was assessed to validate anesthesia success. Subsequently, the operator repeated the cold pulp test on the tooth with pulpitis and adjacent tooth to ensure IANB success. Pulp anesthesia success was determined by the absence of response to the cold test in two consecutive negative evaluations (15). After a 10-minute interval, the operator verified the presence of profound lip numbness (lower teeth) and a negative response to the cold test. Failure to achieve these criteria indicated anesthetic failure, prompting the application of another cartridge (1,8mL) of the same anesthetic solution and technique. Patients who did not exhibit lip numbness or responded positively to the cold test after the second application were excluded from the study. Access cavity preparation commenced 14 to 16 min after the anesthetic technique initiation. Patients were instructed to report any discomfort during the procedure. If supplemental techniques such as intraligamentary or intrapulpal anesthesia were necessary during pulpectomy, they were documented. In order to confirm the succes of the anesthesia, the intensity of any pain felt during the pulpectomy was evaluated using the same 4-point scale described above. Anesthesia efficacy was deemed successful if the operator accessed the pulp chamber without the patient reporting pain (pain scores of no pain or mild pain), allowing the procedure to continue. In cases where pain was reported as moderate or severe, anesthesia efficacy was classified as unsuccessful. The extent of access achieved (within the dentin, pulp chamber, or root canal) was recorded, and supplemental anesthesia techniques (intraligamentary or intrapulpal) were administered based on the pain level at the site before completing the pulpectomy. Statistical analyses This was a pilot proof-of-principle study using a convenience sample of 26 participants. Data were entered into an Excel database (Microsoft Office for Windows XP) and analyzed using SPSS 21.0 (Using Statistical Package for Social Sciences software version 21.0). Fisher's exact test was employed to detect statistically significant differences in anesthesia efficacy between the two study groups and pre-operative variables. A p-value p<0.05, set at 5%, was considered statistically significant. Patient information was treated with strict confidentiality. Each patient was assigned an alphanumeric code to maintain anonymity in all study documentation. The investigator securely stored clinical records, and relevant study documents were archived as per legal requirements, ensuring data security and integrity. Results The analysis revealed no statistically significant differences between patients in the two test groups regarding gender distribution, age (mean age: mepivacaine group, 38 years; cold mepivacaine group, 37 years), or the types of teeth affected by irreversible pulpitis (Table 1). Four participants had a history of smoking, but smoking habits did not correlate with anesthesia success. All cases (19 out of 20) were diagnosed with symptomatic irreversible pulpitis, with one case of asymptomatic irreversible pulpitis. In addition, 12 patients presented with symptomatic apical periodontitis, with one case of asymptomatic periodontitis and seven with normal periapical tissues. Furthermore, five patients took premedication 4 hours before treatment initiation (Table 2). Regarding pretreatment anxiety levels, assessed using the VAS, 3 patients recorded no anxiety, 7 experienced mild anxiety, 6 experienced anxiety, and 4 patients recorded severe anxiety. Preoperative was also evaluated using the VAS, with 2 patients reporting no pain unless provoked by a stimulus, 5 experiencing mild pain, 4 experiencing moderate pain, and 9 reporting severe pain (Table 2). None of the pre-operative variables, including anxiety and pain levels, showed statistical significance concerning pain control, indicating homogeneity between groups and enabling a direct comparison of anesthesia outcomes. Out of the initial 26 patients selected for the study, 6 patients were excluded: 4 due to diagnosis criteria and 2 who declined to participate in the study. All pacients reported subjective lip anesthesia 10 minutes post IANB, however, 2 patients did not achieve the maximum cold test output without experiencing pain, even after the second cartridge was administrated (Fig 1). Three patients experienced pain during anesthetic injection; however, no significant differences were observed between groups regarding pain experienced during injection (p>0.5). Nonetheless, a notable discrepancy was observed during access cavity preparation, with better outcomes noted in the experimental groups (20%) compared to the control group (80%) (Table 3). Discussion Patients with irreversible pulpitis often experience more pain during root canal treatment than those with pulpal necrosis or asymptomatic apical periodontitis, particularly in mandibular teeth compared to maxilla teeth (6). Consequently, understanding the efficacy of anesthetics becomes paramount. Dental clinicians commonly use five solutions: articaine, prilocaine, bupivacaine, lidocaine, and mepivacaine. However, complications such as paresthesia and methemoglobinemia have been associated with the administration of articaine and prilocaine (9), while bupivacaine carries the risk of cardiac and central nervous system problems (16). Despite the advantages of lidocaine, categorized as a class B drug and recommended during pregnancy, mepivacaine— a class C drug—offers comparable or superior vasoconstrictor effects due to its lower vasodilation capacity, positioning it as an alternative (17). Patient anxiety, premedication with non-steroidal anti-inflammatory drugs (NSAIDs), preoperative pain, pulp and periapical diagnosis, and tooth type have been reported as factors influencing anesthesia success during dental procedures. However, in our study, none of the preoperative variables demonstrated statistical relevance in anesthesia success. Anxiety levels in patients with irreversible pulpitis have been reported to surpass those in the general population (18). Heightened anxiety correlates with increased pain, underscoring the interplay between anxiety and pain perception (19). In the present study, pretreatment anxiety levels were assessed using VAS, revealing varying degrees of anxiety among patients. Premedication with NSAIDs has shown efficacy in enhancing the success of IANB compared to placebo groups (20). However, in our study, only a minority of patients received NSAIDs, rendering its impact negligible. One study has suggested that patients with mild preoperative pain (29%) exhibit better anesthesia success rates than those patients with severe preoperative pain (16%) (21). However, our study contradicts this finding, as preoperative pain did not correlate significantly with anesthesia success, aligning with a study that found no significant association between pain levels and IANB success (22). Other preoperative variables were pulpal and periapical diagnosis, with previous studies indicating higher anesthetic efficacy in patients with asymptomatic irreversible pulpitis compared to those with symptomatic irreversible pulpitis (23). However, in the present study, there was only one case of asymptomatic irreversible pulpitis. Tooth type is also a significant factor influencing anesthesia, with mandibular molars presenting a higher risk of anesthetic failure with IANB. Conversely, a single buccal infiltration may not suffice to achieve adequate anesthesia in maxillary molars with a long palatal root and irreversible pulpitis. (24). Pain during anesthesia injection is a common source of anxiety for patients. This discomfort can often be attributed to chemical irritation caused by the mildly acidic nature of anesthetic solution and tissue distension (25). Various techniques have been explored to alleviate injection pain, including warming the local anesthesia solution. While some studies suggest that warming the solution reduces injection pain (26), others have found no advantage (27). Interestingly, our study found no significant difference in injection pain between the control and the experimental groups, indicating that cold anesthesia is no more painful than room temperature. These findings align with a randomized controlled trial that reported increased pain on injection with room temperature anesthesia compared to a cooled formulation (13). To our knowledge, research on cooling local anesthesia has primarily focused on cryotherapy. According to one study, cooled anesthesia reduces pain from edema and local inflammation and enhances the effect of local anesthetics (1). In the present study, the overall success rate of the anesthesia technique in the control group was 20%, while in the experimental group; it was 80%, which was statistically significant. These findings are consistent with a study comparing cooled anesthesia and room temperature anesthesia, which reported statistical differences between the control and experimental groups (13). The improved success rate in the experimental group may be attributed to the cooling effect slightly increasing the ionization constant (pKa) value of the anesthetic solution, thereby enhancing its potency (28). However, it is noteworthy that another study found no statistical difference in the onset of anesthesia but it had a longer duration. Nevertheless, this study was limited to maxillary premolars with normal pulp status (14). Another study evaluating the cooling effect of 2% lignocaine with vasoconstrictor and 2% lignocaine without vasoconstrictor for irreversible pulpitis in lower molars found that cold anesthesia had the fastest onset time and caused less pain during injection compared to room temperature and cold anesthesia without vasoconstrictor (29). In the present study, lip numbness and negative cold testing were crucial factors for assessing the adequacy of the anesthetic technique. While all the patients experienced lip numbness, two were excluded due to a positive response to cold stimuli. Therefore, the success of IANB is considered a crucial factor. Lip numbness is commonly believed to indicate anesthesia success, but this may not always correlate with pulpal anesthesia, particularly in cases of inflamed pulps. In contrast, cold testing may offer a higher level of reliability than lip numbness in patients with irreversible pulpitis (30). The cold test is recommended for assessing pulpal anesthesia due to its ease of use, rapidity, cost-effectiveness, good patient tolerance, and minimal risk of adverse effects on the pulp with repeated use (31). The present study employed buccal infiltration as a common technique for achieving pulpal anesthesia in maxillary molars, administering 3.6mL of local anesthetic. However, the success of pulpal anesthesia is notably compromised in cases of irreversible pulpitis compared to normal pulp conditions (32). Clinical studies have highlighted the inefficacy of a single IANB injection in 30–80% of cases of irreversible pulpitis (3). In our investigation, 1.8mL of buccal infiltration was supplemented with IANB in lower molars. Throughout the endodontic procedure, the control group exhibited higher levels of pain compared to the experimental group. Supplemental intraligamentary anesthesia with 3% mepivacaine administered either cold or at room temperature, depending on the group allocation, was employed. These outcomes align with previous research indicating the necessity of supplemental techniques in 54% of cases due to the insufficient efficacy of IANB alone. Statistically significant differences were observed between buccal infiltration and intraosseous anesthesia as preferred supplemental techniques, with intraosseous anesthesia posing a higher risk of osteomyelitis (33). Conclusion Our study revealed a higher success rate of mepivacaine at 5°C compared to temperature mepivacaine, with statistically significant differences. These findings suggest a promising outlook for cold anesthetic solutions in enhancing anesthesia success during endodontic treatment. However, further research with a larger sample size is warranted to strengthen the evidence base. Despite the rejection of our initial hypothesis, the significant differences observed between the two types of mepivacaine underscore the potential benefits of temperature modulation in pain management during endodontic treatment in cases of irreversible pulpitis. Therefore, within the limitations of this clinical trial, it can be concluded that the lower 3% mepivacaine from room temperature to 5°C demonstrates a higher success rate. Declarations Funding The authors declare that none of the findings reported in this study could have been influenced by any known competing financial interests or personal relationships. Conflict of interest The authors deny any conflicts of interest related to this study. References Koteeswaran V, Ballal S, Natanasabapathy V, Kowsky D (2018) Efficacy of Endo- Ice followed by intrapulpal ice application as an adjunct to inferior alveolar nerve block in patients with symptomatic irreversible pulpitis—a randomized controlled trial. Clin Oral Investig 3:501–507 Yu C, Abbott PV (2007) An overview of the dental pulp: Its functions and responses to injury. Aust Dent J 52:S4–6 Hargreaves KM, Keiser K (2002) Local anaesthetic failure in endodontics: mechanisms and management. Endodontic Top 1:26–39 Vieira WA, Paranhos LR, Cericato GO, Franco A, Ribeiro MAG (2018) Is mepivacaine as effective as lidocaine during inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis? A systematic review and meta-analysis. Int Endod J 51:1104–1117 St George G, Morgan A, Meechan J, Needleman I, Yl N, Petrie A (2018) Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev 7:1–25 Nagendrababu V, Pulikkotil SJ, Suresh A, Veettil SK, Bhatia S, Setzer FC (2019) Efficacy of local anaesthetic solutions on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a systematic review and network meta-analysis of randomized clinical trials. Int Endod J 52:779–789 Parirokh M, Kakooei S, Nakhaee N, Manochehrifar H, Abbott P (2022) The effect of the anatomic variables on the success rate of anesthesia in maxillary molars with irreversible pulpitis. 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Anesth Prog 62:135–139 Chavarría-Bolaños D, Rodríguez-Wong L, Noguera-González D, Esparza-Villalpando V, Montero-Aguilar M, Pozos-Guillén A Accuracy of three diagnostic tests to predict inferior alveolar nerve blockade failure in symptomatic irreversible pulpitis. Pain Res Manag 2017:1–8 Argueta-Figueroa L, Arzate-Sosa G, Mendieta-Zenon H (2012) Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with symptomatic versus asymptomatic irreversible pulpitis. Gen Dent 60:39–43 Parirokh M, Samadi I, Nakhaee NAP (2021) Comparison of the anaesthesia success rate in maxillary first and second molars with 3% Prilocaine as the anaesthetic agent. Eur Endod J 6:254–258 Malamed SF (2004) Handbook of Local Anesthesia, 5th edn. Mosby, St Louis, MO Davidson JA, Boom SJ (1992) Warming lignocaine to reduce pain associated with injection. BMJ 305:617–618 Dalton AM, Sharma A, Redwood M, Wadsworth J, Touquet R (1989) Does the warming of local anaesthetic reduce the pain of its injection? Arch Emerg Med 6:247–250 Setnikar I (1966) Ionization of bases with limited solubility. Investigation of substances with local anesthetic activity. J Pharm Sci 55:1190–1195 Vasanthakumar A, Velmurugan NAM et al (2013) Effects of cooling lignocaine hydrochloride for inferior alveolar nerve block - a randomised controlled trial. L Engl 7:1–6 Noguera-Gonzalez D, Cerda-Cristerna BI, Chavarria- Bolaños D, Flores-Reyes H, Pozos-Guillen A (2013) Efficacy of preoperative ibuprofen on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J 46:1056–1062 Hsiao-Wu GW, Susarla SM, White RR (2007) Use of the cold test as a measure of pulpal anesthesia during endodontic therapy: a randomized, blinded, placebo-controlled clinical trial. J Endod 33:406–410 Aggarwal V, Jain A, Debipada K (2009) Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine following an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod 35:925–929 Kanaa MD, Whitworth JM, Meechan JG (2012) Randomized clinical trial a prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod 38:421–425 Tables Table 1 Statistical analysis was conducted using the Mann-Whitney test for age distributions and Fisher ' s exact test for gender distribution. No significant differences were observed between groups regarding gender distribution and mean age. Group I (Control Group) Mean ± SD Group II (Experimental Group) Mean ± SD Age (years) 38,30 ± 16,88 37 ± 8,9 p = .935 ns Gender 6/4 3/7 p = .370 ns Table 2 Frequencies of preoperative variables. Preoperative Variables N N(%) Anxiety No Anxiety 3 15% Mild 7 35% Moderate 6 30% Severe 4 20% Preoperative pain No Pain 2 10% Mild 5 25% Moderate 4 20% Severe 9 45% Premedication Yes 5 25% No 15 75% Pulp diagnosis Symptomatic 19 95% Asymptomatic 1 5% Periapical diagnosis Symptomatic 12 60% Asymptomatic 1 5% Normal 7 35% Tooth type Maxillary molars 12 60% Mandibular molars 8 40% Table 3 Statistical analysis was conducted using Fisher ' s exact test Group I (Control Group) Group II (Experimental Group) Pain on injection 10% (1/10) 20% (2/10) p = .571 ns Pain during treatment 80% (8/10) 20% (2/10) p = < 0.05 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5460715","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":378593703,"identity":"b2452990-ba93-4bfc-a2c2-cd458086f86b","order_by":0,"name":"Gonzalo Gomez","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA30lEQVRIiWNgGAWjYHAD5gaGDwwSJGlhbGCcQbIWZh5i1Mm7dyc+/PHLJk++/WDjY9s2C3kG9vYHeLUYnjm72UCyL62YsSex2Ti3TcKwgeeMAX4tM3K3SRj2HE5sZkhskwZqSWCQyMHvMKCW7T8SgVra+B+2SVuCtMg/x+8weYncbQwHfhxO7JEA2sIItoUBv8MMeM5ulmxsSEucIfGw2bDnnIRhG08Ofi3y7b0bP/74Y5M4vz/54IMfZXXy/OzH8TvM4ACQYGxDEmHDqx5kSwOI/ENI2SgYBaNgFIxoAAC+yUbW/SeG9QAAAABJRU5ErkJggg==","orcid":"","institution":"Universitat Internacional de Catalunya","correspondingAuthor":true,"prefix":"","firstName":"Gonzalo","middleName":"","lastName":"Gomez","suffix":""}],"badges":[],"createdAt":"2024-11-15 13:08:24","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-5460715/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5460715/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":69361607,"identity":"18b5223a-c9f7-4965-8737-98cc4a994dc3","added_by":"auto","created_at":"2024-11-19 14:24:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":27734,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of patients' progress through the randomized controlled trial\u003c/p\u003e","description":"","filename":"Fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-5460715/v1/d9087f145a954b0d7edcead5.png"},{"id":69361608,"identity":"e9f93715-b267-44a7-8a3a-50663e391652","added_by":"auto","created_at":"2024-11-19 14:24:27","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":13841,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003ePain incidence during endodontic treatment\u003c/em\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5460715/v1/26f3c198313ba0329cf3a464.png"},{"id":72552258,"identity":"c13a1c56-898f-44e7-8c90-2ec3b64c21e8","added_by":"auto","created_at":"2024-12-29 14:38:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":376742,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5460715/v1/1ce65729-abf1-44c2-b89d-19a3105a8635.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Temperature Modulation of Cryoanalgesia for Pain Control in Irreversible Pulpitis: a randomized clinical trial ","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIn endodontics, effective anesthesia is crucial for both patient comfort and the efficiency of the clinical procedure. Anesthesia inadequacy not only heightens patient fear and anxiety but also extends treatment duration, thereby potentially tarnishing the clinician's reputation and undermining confidence in endodontic care (1).\u003c/p\u003e \u003cp\u003eThe efficacy of anesthesia depends on several factors, including the chosen technique and anatomical nuances associated with the inferior alveolar nerve (IAN) in lower molars (2, 3). Moreover, the inflammatory process within the pulp can significantly impede anesthetic efficacy.\u003c/p\u003e \u003cp\u003eThe clinician's principal choice for mandibular molars is the inferior alveolar nerve block (IANB). However, its success rates reduce in the presence of pulpal inflammation, ranging from approximately 20\u0026ndash;70% (4). Conversely, buccal infiltration is the standard technique for maxillary molars. Nevertheless, its efficacy diminishes in teeth afflicted with symptomatic irreversible pulpitis, with failure rates ranging from 28\u0026ndash;47% (5). Supplemental techniques such as buccal infiltration in mandibular molars, periodontal ligament injection, intraosseous anesthesia, and oral premedication have been proposed to bolster anesthesia success rates (6).\u003c/p\u003e \u003cp\u003eAnatomical considerations significantly influence anesthesia success, with mandibular posterior teeth exhibiting markedly higher rates of anesthesia failure compared to other teeth (7).\u003c/p\u003e \u003cp\u003eFurthermore, alterations in pulp characteristics induced by inflammatory processes precipitate anesthetic failure (4), while inflammation-induced vasodilation can expedite systemic absorption, thereby diminishing the concentration of local anesthetics (8).\u003c/p\u003e \u003cp\u003eThe choice of anesthetic solution is also crucial to anesthesia success. Among the array of options in dentistry, lidocaine and 4% articaine stand out as common choices. A systematic review revealed that 4% articaine (with 1:100,000 epinephrine) outperformed lidocaine (2% with 1:100,000 epinephrine) (5) in posterior teeth with inflamed pulps necessitating root canal therapy. However, retrospective studies have hinted at a higher risk of paresthesia linked with articaine (9,10). While a systematic review concluded that articaine could be safe, it underscored limitations in study quality, result consistency, and data precision, which could impinge on the robustness of inferences drawn from systematic reviews. Moreover, selection bias, inherent in all systematic reviews, remains a persistent challenge (11). Another noteworthy anesthetic solution is mepivacaine, available in either 2% concentration with vasoconstrictor or 3% without vasoconstrictor. Mepivacaine boasts favorable chemical properties, including a lower pKa and reduced vasodilation, culminating in prolonged anesthesia duration. Consequently, it is a potentially suitable option for pediatric patients and individuals with systemic disorders (2, 12). Studies comparing mepivacaine to lidocaine have demonstrated no disparities in anesthetic efficacy (5, 11).\u003c/p\u003e \u003cp\u003eDespite extensive research efforts, achieving complete pulpal anesthesia in cases of irreversible pulpitis has remained elusive, prompting endeavors to identify optimal pain management strategies during endodontic procedures (5).\u003c/p\u003e \u003cp\u003eCryoanalgesia has emerged as an effective method of pain management in medical practice. By inducing temperature reduction and vasoconstriction, cold application leads to a decrease in tissue metabolites, inflammatory mediators, and neuropeptides (1). Previous research into cryoanalgesia has yielded promising results. For example, it has been shown that cold refrigerated lignocaine significantly improves anesthetic efficacy compared to lignocaine at room temperature, achieving an 86.6% success rate for maxillary first molars in irreversible pulpitis (13). Similarly, another study comparing cold refrigerated mepivacaine with room temperature mepivacaine in healthy maxillary first premolars revealed no significant differences in the onset of pulp anesthesia; however, cold refrigerated mepivacaine exhibited a longer duration of action (14).\u003c/p\u003e \u003cp\u003eNo prior research appears to have explored the influence of temperature on the action of 3% mepivacaine in irreversible pulpitis. Therefore, the present study aimed to assess the efficacy of cold refrigerated 3% mepivacaine compared to 3% mepivacaine at room temperature in teeth diagnosed with irreversible pulpitis. The null hypothesis posited no difference between the two types of this local anesthetic.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003e\u003cu\u003eEthical approval\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was registered in ClinicalTrials.gov registry (ID: NCT06268912). This randomized clinical trial has been written approved by the Ethics in Human Research Committee (END-ECL-2022-01) and conducted from September 2022 to May 2023. The trial was registered on ClinicalTrials.gov (ID: NCT06268912) and has been written according CONSORTS 2010 guidelines.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStudy design and clinical data collection\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eA total of 26 participants were enrolled, inclusion criteria were healthy individuals classified according to the American Society of Anesthesiologists ASA I-II, aged between 18 and 60 years, presenting with irreversible pulpitis. Exclusion criteria were (ASA III-VI), pregnant or lactating individuals, those with known allergies or sensitivities to study substances, pulp necrosis, ongoing treatment, acute or chronic apical abscess, non-restorable teeth, and cases of unsuccessful anesthesia techniques (absence of lip numbness for lower molars or positive response to cold test).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants were diagnosed with irreversible pulpitis in molar teeth, adhering to specific inclusion and exclusion criteria. Detailed written and verbal information about the study was provided, and participants gave written informed consent. Diagnosis of irreversible pulpitis followed the American Association of Endodontics guidelines, characterized by sharp pain upon thermal stimuli, lingering pain (often exceeding 30 seconds after stimulus removal), spontaneous or unprovoked pain, and referred pain.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSubsequently, participants rated their preoperative pain and anxiety using the Heft-Parker Visual Analog Scale (VAS). Anxiety Levels on the one VAS were categorized into four sections: no anxiety (0 mm), mild anxiety (\u0026gt;zero to \u0026le;54mm, moderate anxiety \u0026gt;54 mm to \u0026lt;114 mm), and severe anxiety (\u0026ge; 114). Preoperative pain levels were similarly measured.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants were randomly assigned to one of two groups, with 13 patients each group: Group 1 received 3% mepivacaine at room temperature, and Group 2 received 3% mepivacaine at 5\u0026ordm;C. The same clinician (J.T.), a final-year resident, performed all treatment procedures. Anesthetics administered using a self-aspirating syringe with a 25 mm 30-gauge needle. For maxillary teeth, buccal and palatal infiltration was performed, while for lower molars, the inferior alveolar nerve block (IANB)\u0026nbsp;and buccal infiltration were administered. The first cartridge was administered over approximately 2 minutes, and the second buccal infiltration was administered either for maxillary teeth or mandibular teeth with 1 cartridge of 1.8ml. A blood aspiration test was conducted for each anesthetic injection. The total dose of anesthetic solution administered before treatment initiation was 3.6 ml.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTen minutes post-initial anesthesia, lip numbness (specifically for lower teeth) was assessed to validate anesthesia success. Subsequently, the operator repeated the cold pulp test on the tooth with pulpitis and adjacent tooth to ensure IANB success. Pulp anesthesia success was determined by the absence of response to the cold test in two consecutive negative evaluations (15). After a 10-minute interval, the operator verified the presence of profound lip numbness (lower teeth) and a negative response to the cold test. Failure to achieve these criteria indicated anesthetic failure, prompting the application of another cartridge (1,8mL) of the same anesthetic solution and technique. Patients who did not exhibit lip numbness or responded positively to the cold test after the second application were excluded from the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAccess cavity preparation commenced 14 to 16 min after the anesthetic technique initiation. Patients were instructed to report any discomfort during the procedure. If supplemental techniques such as intraligamentary or intrapulpal anesthesia were necessary during pulpectomy, they were documented. In order to confirm the succes of the anesthesia, the intensity of any pain felt during the pulpectomy was evaluated using the same 4-point scale described above. Anesthesia efficacy was deemed successful if the operator accessed the pulp chamber without the patient reporting pain (pain scores of no pain or\u0026nbsp;mild\u0026nbsp;pain), allowing the procedure to continue. In cases where pain was reported as\u0026nbsp;moderate or\u0026nbsp;severe, anesthesia efficacy was classified as unsuccessful. The extent of access achieved (within the dentin, pulp chamber, or root canal) was recorded, and supplemental anesthesia techniques (intraligamentary or intrapulpal) were administered based on the pain level at the site before completing the pulpectomy.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStatistical analyses\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThis was a pilot proof-of-principle study using a convenience sample of 26 participants. Data were entered into an Excel database (Microsoft Office for Windows XP) and analyzed using SPSS 21.0 (Using Statistical Package for Social Sciences software version 21.0). Fisher\u0026apos;s exact test was employed to detect statistically significant differences in anesthesia efficacy between the two study groups and pre-operative variables. A p-value p\u0026lt;0.05, set at 5%, was considered statistically significant.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatient information was treated with strict confidentiality. Each patient was assigned an alphanumeric code to maintain anonymity in all study documentation. The investigator securely stored clinical records, and relevant study documents were archived as per legal requirements, ensuring data security and integrity.\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe analysis revealed no statistically significant differences between patients in the two test groups regarding gender distribution, age (mean age: mepivacaine group, 38 years; cold mepivacaine group, 37 years), or the types of teeth affected by irreversible pulpitis (Table 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFour participants had a history of smoking, but smoking habits did not correlate with anesthesia success. All cases (19 out of 20) were diagnosed with symptomatic irreversible pulpitis, with one case of asymptomatic irreversible pulpitis. In addition, 12 patients presented with symptomatic apical periodontitis, with one case of asymptomatic periodontitis and seven with normal periapical tissues. Furthermore, five patients took premedication 4 hours before treatment initiation (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRegarding pretreatment anxiety levels, assessed using the VAS, 3 patients recorded no anxiety, 7 experienced mild anxiety, 6 experienced anxiety, and 4 patients recorded severe anxiety. Preoperative was also evaluated using the VAS, with 2 patients reporting no pain unless provoked by a stimulus, 5 experiencing mild pain, 4 experiencing moderate pain, and 9 reporting severe pain (Table 2). None of the pre-operative variables, including anxiety and pain levels, showed statistical significance concerning pain control, indicating homogeneity between groups and enabling a direct comparison of anesthesia outcomes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOut of the initial 26 patients selected for the study, 6 patients were excluded: 4 due to diagnosis criteria and 2 who declined to participate in the study.\u0026nbsp;All pacients reported subjective lip anesthesia 10 minutes post IANB, however, 2 patients did not achieve the maximum cold test output without experiencing pain, even after the second cartridge was administrated (Fig 1). Three patients experienced pain during anesthetic injection; however, no significant differences were observed between groups regarding pain experienced during injection (p\u0026gt;0.5).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNonetheless, a notable discrepancy was observed during access cavity preparation, with better outcomes noted in the experimental groups (20%) compared to the control group (80%) (Table 3).\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePatients with irreversible pulpitis often experience more pain during root canal treatment than those with pulpal necrosis or asymptomatic apical periodontitis, particularly in mandibular teeth compared to maxilla teeth (6). Consequently, understanding the efficacy of anesthetics becomes paramount. Dental clinicians commonly use five solutions: articaine, prilocaine, bupivacaine, lidocaine, and mepivacaine. However, complications such as paresthesia and methemoglobinemia have been associated with the administration of articaine and prilocaine (9), while bupivacaine carries the risk of cardiac and central nervous system problems (16). Despite the advantages of lidocaine, categorized as a class B drug and recommended during pregnancy, mepivacaine\u0026mdash; a class C drug\u0026mdash;offers comparable or superior vasoconstrictor effects due to its lower vasodilation capacity, positioning it as an alternative (17).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatient anxiety, premedication with non-steroidal anti-inflammatory drugs (NSAIDs), preoperative pain, pulp and periapical diagnosis, and tooth type have been reported as factors influencing anesthesia success during dental procedures. However, in our study, none of the preoperative variables demonstrated statistical relevance in anesthesia success.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnxiety levels in patients with irreversible pulpitis have been reported to surpass those in the general population (18). Heightened anxiety correlates with increased pain, underscoring the interplay between anxiety and pain perception (19). In the present study, pretreatment anxiety levels were assessed using VAS, revealing varying degrees of anxiety among patients. Premedication with NSAIDs has shown efficacy in enhancing the success of IANB compared to placebo groups (20). However, in our study, only a minority of patients received NSAIDs, rendering its impact negligible.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOne study has suggested that patients with mild preoperative pain (29%) exhibit better anesthesia success rates than those patients with severe preoperative pain (16%) (21). However, our study contradicts this finding, as preoperative pain did not correlate significantly with anesthesia success, aligning with a study that found no significant association between pain levels and IANB success (22). Other preoperative variables were pulpal and periapical diagnosis, with previous studies indicating higher anesthetic efficacy in patients with asymptomatic irreversible pulpitis compared to those with symptomatic irreversible pulpitis (23). However, in the present study, there was only one case of asymptomatic irreversible pulpitis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTooth type is also a significant factor influencing anesthesia, with mandibular molars presenting a higher risk of anesthetic failure with IANB. Conversely, a single buccal infiltration may not suffice to achieve adequate anesthesia in maxillary molars with a long palatal root and irreversible pulpitis. (24).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePain during anesthesia injection is a common source of anxiety for patients. This discomfort can often be attributed to chemical irritation caused by the mildly acidic nature of anesthetic solution and tissue distension (25). Various techniques have been explored to alleviate injection pain, including warming the local anesthesia solution. While some studies suggest that warming the solution reduces injection pain (26), others have found no advantage (27). Interestingly, our study found no significant difference in injection pain between the control and the experimental groups, indicating that cold anesthesia is no more painful than room temperature. These findings align with a randomized controlled trial that reported increased pain on injection with room temperature anesthesia compared to a cooled formulation (13).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo our knowledge, research on cooling local anesthesia has primarily focused on cryotherapy. According to one study, cooled anesthesia reduces pain from edema and local inflammation and enhances the effect of local anesthetics (1). In the present study, the overall success rate of the anesthesia technique in the control group was 20%, while in the experimental group; it was 80%, which was statistically significant. These findings are consistent with a study comparing cooled anesthesia and room temperature anesthesia, which reported statistical differences between the control and experimental groups (13).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe improved success rate in the experimental group may be attributed to the cooling effect slightly increasing the ionization constant (pKa) value of the anesthetic solution, thereby enhancing its potency (28). However, it is noteworthy that another study found no statistical difference in the onset of anesthesia but it had a longer duration. Nevertheless, this study was limited to maxillary premolars with normal pulp status (14). Another study evaluating the cooling effect of 2% lignocaine with vasoconstrictor and 2% lignocaine without vasoconstrictor for irreversible pulpitis in lower molars found that cold anesthesia had the fastest onset time and caused less pain during injection compared to room temperature and cold anesthesia without vasoconstrictor (29).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn the present study, lip numbness and negative cold testing were crucial factors for assessing the adequacy of the anesthetic technique. While all the patients experienced lip numbness, two were excluded due to a positive response to cold stimuli. Therefore, the success of IANB is considered a crucial factor. Lip numbness is commonly believed to indicate anesthesia success, but this may not always correlate with pulpal anesthesia, particularly in cases of inflamed pulps. In contrast, cold testing may offer a higher level of reliability than lip numbness in patients with irreversible pulpitis (30). The cold test is recommended for assessing pulpal anesthesia due to its ease of use, rapidity, cost-effectiveness, good patient tolerance, and minimal risk of adverse effects on the pulp with repeated use (31).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe present study employed buccal infiltration as a common technique for achieving pulpal anesthesia in maxillary molars, administering 3.6mL of local anesthetic. However, the success of pulpal anesthesia is notably compromised in cases of irreversible pulpitis compared to normal pulp conditions (32). Clinical studies have highlighted the inefficacy of a single IANB injection in 30\u0026ndash;80% of cases of irreversible pulpitis (3). In our investigation, 1.8mL of buccal infiltration was supplemented with IANB in lower molars.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThroughout the endodontic procedure, the control group exhibited higher levels of pain compared to the experimental group. Supplemental intraligamentary anesthesia with 3% mepivacaine administered either cold or at room temperature, depending on the group allocation, was employed. These outcomes align with previous research indicating the necessity of supplemental techniques in 54% of cases due to the insufficient efficacy of IANB alone. Statistically significant differences were observed between buccal infiltration and intraosseous anesthesia as preferred supplemental techniques, with intraosseous anesthesia posing a higher risk of osteomyelitis (33).\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOur study revealed a higher success rate of mepivacaine at 5\u0026deg;C compared to temperature mepivacaine, with statistically significant differences. These findings suggest a promising outlook for cold anesthetic solutions in enhancing anesthesia success during endodontic treatment. However, further research with a larger sample size is warranted to strengthen the evidence base. Despite the rejection of our initial hypothesis, the significant differences observed between the two types of mepivacaine underscore the potential benefits of temperature modulation in pain management during endodontic treatment in cases of irreversible pulpitis. Therefore, within the limitations of this clinical trial, it can be concluded that the lower 3% mepivacaine from room temperature to 5\u0026deg;C demonstrates a higher success rate.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that none of the findings reported in this study could have been influenced by any known competing financial interests or personal relationships.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors deny any conflicts of interest related to this study.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKoteeswaran V, Ballal S, Natanasabapathy V, Kowsky D (2018) Efficacy of Endo- Ice followed by intrapulpal ice application as an adjunct to inferior alveolar nerve block in patients with symptomatic irreversible pulpitis\u0026mdash;a randomized controlled trial. Clin Oral Investig 3:501\u0026ndash;507\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu C, Abbott PV (2007) An overview of the dental pulp: Its functions and responses to injury. Aust Dent J 52:S4\u0026ndash;6\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHargreaves KM, Keiser K (2002) Local anaesthetic failure in endodontics: mechanisms and management. Endodontic Top 1:26\u0026ndash;39\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVieira WA, Paranhos LR, Cericato GO, Franco A, Ribeiro MAG (2018) Is mepivacaine as effective as lidocaine during inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis? A systematic review and meta-analysis. Int Endod J 51:1104\u0026ndash;1117\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSt George G, Morgan A, Meechan J, Needleman I, Yl N, Petrie A (2018) Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev 7:1\u0026ndash;25\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNagendrababu V, Pulikkotil SJ, Suresh A, Veettil SK, Bhatia S, Setzer FC (2019) Efficacy of local anaesthetic solutions on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a systematic review and network meta-analysis of randomized clinical trials. Int Endod J 52:779\u0026ndash;789\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eParirokh M, Kakooei S, Nakhaee N, Manochehrifar H, Abbott P (2022) The effect of the anatomic variables on the success rate of anesthesia in maxillary molars with irreversible pulpitis. J Endod 48:707\u0026ndash;713\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVandermeulen E (2000) Pain perception, mechanisms of action of local anesthetics and possible causes of failure. Rev Belge Med Dent 55:29\u0026ndash;40\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaas DA, Lennon D (1995) A 21 year retrospective study of reports of paresthesia following local anaesthetic administration. J Can Dent Assoc 61:319\u0026ndash;320\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHopman AJG, Baart JA, Brand HS (2017) Articaine and neurotoxicity-A review. Br Dent J 223:501\u0026ndash;506\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSu N, Li C, Wang H et al (2016) Efficacy and safety of articaine versus lidocaine for irreversible pulpitis treatment: A systematic review and meta-analysis of randomised controlled trials. Aust Endod J 42:4\u0026ndash;15\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVirdee SS, Seymour D, Bhakta S (2015) Effective anaesthesia of the acutely inflamed pulp: part 1. The acutely inflamed pulp. Br Dent J 219:385\u0026ndash;390\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGurucharan I, Sekar M, Balasubramanian S, Narasimhan S (2021) Effect of precooling injection site and cold anesthetic administration on injection pain, onset, and anesthetic efficacy in maxillary molars with symptomatic irreversible pulpitis: a randomized controlled trial. Clin Oral Investig 26:1855\u0026ndash;1860\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDabarakis N, Tsirlis A, Parisis N, Tsoukalas D (2006) The role of temperature in the action of mepivacaine. Anesth Prog 53:91\u0026ndash;94\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl Sayed M, Gaballah K Postanesthetic cold sensibility test as an Indicator for the efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis of mandibular molars. Int J Dent 2021:1\u0026ndash;11\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNaguib M, Magboul MM, Samarkandi AH, Attia M (1998) Adverse effects and drug interactions associated with local and regional anaesthesia. Drug Saf 18:221\u0026ndash;250\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSu N, Liu Y, Yang X, Shi Z, Huang Y (2014) Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: A meta-analysis of randomised controlled trials. Int Dent J 64:96\u0026ndash;107\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDou L, Vanschaayk MM, Zhang Y, Fu X, Ji P, Yang D (2018) The prevalence of dental anxiety and its association with pain and other variables among adult patients with irreversible pulpitis. BMC Oral Health 18:1\u0026ndash;6\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLin C, Wu S, Yi C (2017) Association between anxiety and pain in dental treatment : A systematic review and meta-analysis. J Dent Res 96:155\u0026ndash;162\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC (2018) Effect of oral premedication on the anaesthetic efficacy of inferior alveolar nerve block in patients with irreversible pulpitis \u0026ndash; A systematic review and network meta-analysis of randomized controlled trials. Int Endod J 51:989\u0026ndash;1004\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAggarwal V, Singla M, Geethapriya N (2006) Effect of preoperative pain on inferior alveolar Nerve Block. Anesth Prog 62:135\u0026ndash;139\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChavarr\u0026iacute;a-Bola\u0026ntilde;os D, Rodr\u0026iacute;guez-Wong L, Noguera-Gonz\u0026aacute;lez D, Esparza-Villalpando V, Montero-Aguilar M, Pozos-Guill\u0026eacute;n A Accuracy of three diagnostic tests to predict inferior alveolar nerve blockade failure in symptomatic irreversible pulpitis. Pain Res Manag 2017:1\u0026ndash;8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArgueta-Figueroa L, Arzate-Sosa G, Mendieta-Zenon H (2012) Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with symptomatic versus asymptomatic irreversible pulpitis. Gen Dent 60:39\u0026ndash;43\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eParirokh M, Samadi I, Nakhaee NAP (2021) Comparison of the anaesthesia success rate in maxillary first and second molars with 3% Prilocaine as the anaesthetic agent. Eur Endod J 6:254\u0026ndash;258\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMalamed SF (2004) Handbook of Local Anesthesia, 5th edn. Mosby, St Louis, MO\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDavidson JA, Boom SJ (1992) Warming lignocaine to reduce pain associated with injection. BMJ 305:617\u0026ndash;618\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDalton AM, Sharma A, Redwood M, Wadsworth J, Touquet R (1989) Does the warming of local anaesthetic reduce the pain of its injection? Arch Emerg Med 6:247\u0026ndash;250\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSetnikar I (1966) Ionization of bases with limited solubility. Investigation of substances with local anesthetic activity. J Pharm Sci 55:1190\u0026ndash;1195\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVasanthakumar A, Velmurugan NAM et al (2013) Effects of cooling lignocaine hydrochloride for inferior alveolar nerve block - a randomised controlled trial. L Engl 7:1\u0026ndash;6\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNoguera-Gonzalez D, Cerda-Cristerna BI, Chavarria- Bola\u0026ntilde;os D, Flores-Reyes H, Pozos-Guillen A (2013) Efficacy of preoperative ibuprofen on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J 46:1056\u0026ndash;1062\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHsiao-Wu GW, Susarla SM, White RR (2007) Use of the cold test as a measure of pulpal anesthesia during endodontic therapy: a randomized, blinded, placebo-controlled clinical trial. J Endod 33:406\u0026ndash;410\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAggarwal V, Jain A, Debipada K (2009) Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine following an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod 35:925\u0026ndash;929\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKanaa MD, Whitworth JM, Meechan JG (2012) Randomized clinical trial a prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod 38:421\u0026ndash;425\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv id=\"Fig1\" class=\"Figure\"\u003e\u0026nbsp;\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Italic\"\u003eStatistical analysis was conducted using the Mann-Whitney test for age distributions and Fisher\u003c/span\u003e\u0026apos;\u003cspan class=\"Italic\"\u003es exact test for gender distribution. No significant differences were observed between groups regarding gender distribution and mean age.\u003c/span\u003e\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGroup I (Control Group)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGroup II (Experimental Group)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAge (years)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e38,30\u0026thinsp;\u0026plusmn;\u0026thinsp;16,88\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e37\u0026thinsp;\u0026plusmn;\u0026thinsp;8,9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;.935\u003csup\u003ens\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGender\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6/4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3/7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;.370\u003csup\u003ens\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\u0026nbsp;\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFrequencies of preoperative variables.\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePreoperative Variables\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eN\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eN(%)\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAnxiety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNo Anxiety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMild\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e35%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eModerate\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e30%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSevere\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePreoperative pain\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNo Pain\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e10%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMild\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e25%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eModerate\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSevere\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e45%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePremedication\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eYes\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e25%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNo\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e75%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePulp diagnosis\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSymptomatic\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e95%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAsymptomatic\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePeriapical diagnosis\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSymptomatic\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e60%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAsymptomatic\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNormal\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e35%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTooth type\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMaxillary molars\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e60%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMandibular molars\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e40%\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Italic\"\u003eStatistical analysis was conducted using Fisher\u003c/span\u003e\u0026apos;\u003cspan class=\"Italic\"\u003es exact test\u003c/span\u003e\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGroup I (Control Group)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGroup II (Experimental Group)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePain on injection\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e10% (1/10)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20% (2/10)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;.571\u003csup\u003ens\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePain during treatment\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e80% (8/10)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20% (2/10)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ep\u0026thinsp;=\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Cryoanalgesia, Irreversible Pulpitis, Temperature Modulation, Pain Management, Cold Therapy, Local Anesthesia.","lastPublishedDoi":"10.21203/rs.3.rs-5460715/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5460715/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjetives:\u003c/strong\u003eThis prospective, randomized clinical trial aimed to evaluate the efficacy of pulpal anesthesia in pain control during endodontic procedures by comparing administration of 3% mepivacaine at refrigerated temperature to 3% mepivacaine at room temperature in teeth diagnosed with irreversible pulpitis. The null hypothesis posited no difference between the two types of this local anesthetic.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods:\u003c/strong\u003eTwenty-six patients diagnosed with irreversible pulpitis of teeth were randomly distributed in two groups. Group 1 received 3% mepivacaine at room temperature, while Group 2 received 3% mepivacaine at 5°C. Preoperative variables were assessed, including pulp and periapical diagnosis, tooth type, pain levels, and anxiety level. Following administration of 3.6ml of local anesthesia, treatment commenced. Pain experienced during injection and pulpectomy were recorded. Fisher's exact test was employed to analyze preoperative factors and anesthetic success, with statistical significance set at p\u0026lt;0.05.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003eThe study findings revealed statistical differences in the success rate of anesthesia between the two groups. Group 2, which received mepivacaine at 5°C, exhibited an 80% higher success rate than Group I, which received mepivacaine at room temperature (20%). None of the preoperative variables demonstrated a significant correlation with anesthetic success.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eWithin the constraints of this clinical trial, it can be inferred that lowering the temperature of plain 3% mepivacaine from room temperature to 5°C enhances the success rate in pain management during treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Relevance \u003c/strong\u003eThis article reports on a randomized clinical trial demonstrating that cooling 3% mepivacaine to 5°C significantly improves anesthetic success and pain management in cases of irreversible pulpitis during endodontic procedures.\u003c/p\u003e","manuscriptTitle":"Temperature Modulation of Cryoanalgesia for Pain Control in Irreversible Pulpitis: a randomized clinical trial ","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-19 14:24:07","doi":"10.21203/rs.3.rs-5460715/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"4922e0b4-a2fd-4ef2-adc6-177267fa963a","owner":[],"postedDate":"November 19th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-29T14:38:08+00:00","versionOfRecord":[],"versionCreatedAt":"2024-11-19 14:24:07","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5460715","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5460715","identity":"rs-5460715","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}