Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications.

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Overuse of antibiotics in such cases contributes to antimicrobial resistance. The appropriateness of antibiotic use must be evaluated to ensure rational prescribing and minimize unnecessary prescriptions. Objectives This review aims to evaluate the effectiveness and associated signs and symptoms of empiric antibiotic treatment for ≤5 days compared to >5 days in patients presenting with dental pain. Methods This protocol has been conducted following PRISMA-P guidelines. A comprehensive search of four electronic databases, such as PubMed, Scopus, Cochrane and Embase was performed to find pertinent studies. This study will follow PICOS framework, including individuals receiving antibiotic treatment for oro-facial pain. Randomized controlled trials evaluating the use of empirical antibiotics for 5 days for dental pain management. Outcomes assessed will be pain reduction, quality of life improvement, adverse events related to antibiotic, clinical resolution, microbiological and radiological findings, biomarkers, antimicrobial resistance, cost implications. Independent reviewers will screen the studies, assess the risk of bias by using RoB-2 and certainty of evidence by using GRADE. Where feasible, a meta-analysis will be conducted to synthesize findings and provide a quantitative summary of the results. Results The study commenced in February 2025 and is anticipated to be completed by May 2025. Conclusions This review will evaluate the effectiveness of antibiotic prescriptions for dental pain, minimizing adverse effects and identifying guideline adherence gaps. Findings will support antibiotic stewardship and inform policies to promote rational use, aiming to curb antimicrobial resistance while ensuring effective, evidence-based pain management in dental practice. 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F1000Research 2025, 14 :415 ( https://doi.org/10.12688/f1000research.163353.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] Previously titled: Systematic review protocol on antibiotic use for orofacial pain: Policy and practice implications Nishant Mehta https://orcid.org/0000-0001-6273-4892 1 , Richa Shrivastava 2 , Neha Patyal https://orcid.org/0000-0002-6115-8878 3 , Arpit Gupta https://orcid.org/0000-0002-6115-8878 4 Nishant Mehta https://orcid.org/0000-0001-6273-4892 1 , Richa Shrivastava 2 , Neha Patyal https://orcid.org/0000-0002-6115-8878 3 , Arpit Gupta https://orcid.org/0000-0002-6115-8878 4 PUBLISHED 22 Jul 2025 Author details Author details 1 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 2 Oral health Sciences Centre, Postgraduate institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 3 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 4 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India Nishant Mehta Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Richa Shrivastava Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Neha Patyal Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Arpit Gupta Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Antimicrobial Resistance collection. Abstract Background Dental pain and intraoral swelling, commonly resulting from pulpal and periapical infections, are leading causes of emergency visits. Overuse of antibiotics in such cases contributes to antimicrobial resistance. The appropriateness of antibiotic use must be evaluated to ensure rational prescribing and minimize unnecessary prescriptions. Objectives This review aims to evaluate the effectiveness and associated signs and symptoms of empiric antibiotic treatment for ≤5 days compared to >5 days in patients presenting with dental pain. Methods This protocol has been conducted following PRISMA-P guidelines. A comprehensive search of four electronic databases, such as PubMed, Scopus, Cochrane and Embase was performed to find pertinent studies. This study will follow PICOS framework, including individuals receiving antibiotic treatment for oro-facial pain. Randomized controlled trials evaluating the use of empirical antibiotics for 5 days for dental pain management. Outcomes assessed will be pain reduction, quality of life improvement, adverse events related to antibiotic, clinical resolution, microbiological and radiological findings, biomarkers, antimicrobial resistance, cost implications. Independent reviewers will screen the studies, assess the risk of bias by using RoB-2 and certainty of evidence by using GRADE. Where feasible, a meta-analysis will be conducted to synthesize findings and provide a quantitative summary of the results. Results The study commenced in February 2025 and is anticipated to be completed by May 2025. Conclusions This review will evaluate the effectiveness of antibiotic prescriptions for dental pain, minimizing adverse effects and identifying guideline adherence gaps. Findings will support antibiotic stewardship and inform policies to promote rational use, aiming to curb antimicrobial resistance while ensuring effective, evidence-based pain management in dental practice. READ ALL READ LESS Keywords Orofacial Pain, Antimicrobial resistance, antimicrobial, practice guidelines, clinical decision making Corresponding Author(s) Arpit Gupta ( [email protected] ) Close Corresponding author: Arpit Gupta Competing interests: No competing interests were disclosed. Grant information: This research is supported by funding from the Department of Health Research, Ministry of Health and Family Welfare, Government of India [Grant number:- EM-Del/Centreforguidelines/DHR/2024]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Mehta N et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Mehta N, Shrivastava R, Patyal N and Gupta A. Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.12688/f1000research.163353.2 ) First published: 08 Apr 2025, 14 :415 ( https://doi.org/10.12688/f1000research.163353.1 ) Latest published: 22 Jul 2025, 14 :415 ( https://doi.org/10.12688/f1000research.163353.2 ) Revised Amendments from Version 1 In this revised version of our article, we have incorporated several important updates and clarifications in response to reviewer feedback. First, to ensure the highest quality of evidence and reduce bias, we limited our inclusion criteria exclusively to randomized controlled trials (RCTs), consistent with PRISMA and Cochrane guidelines. We acknowledge that this may result in a smaller pool of studies, and we have explicitly noted the potential limitations and the need for future high-quality RCTs in this field. Second, we have updated and detailed the search results from multiple databases—PubMed, Embase, Scopus, and Cochrane Central—with exact counts to enhance transparency. Third, while the hand search is planned, its timing is not yet specified and will be conducted subsequently. Fourth, the article title has been revised to better reflect the scope and focus, now titled “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” Finally, we have added a clear statement declaring no competing interests, ensuring full disclosure. These revisions improve the clarity, transparency, and rigor of the protocol compared to the previous version. In this revised version of our article, we have incorporated several important updates and clarifications in response to reviewer feedback. First, to ensure the highest quality of evidence and reduce bias, we limited our inclusion criteria exclusively to randomized controlled trials (RCTs), consistent with PRISMA and Cochrane guidelines. We acknowledge that this may result in a smaller pool of studies, and we have explicitly noted the potential limitations and the need for future high-quality RCTs in this field. Second, we have updated and detailed the search results from multiple databases—PubMed, Embase, Scopus, and Cochrane Central—with exact counts to enhance transparency. Third, while the hand search is planned, its timing is not yet specified and will be conducted subsequently. Fourth, the article title has been revised to better reflect the scope and focus, now titled “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” Finally, we have added a clear statement declaring no competing interests, ensuring full disclosure. These revisions improve the clarity, transparency, and rigor of the protocol compared to the previous version. See the authors' detailed response to the review by Sanjana Santhosh Kumar See the authors' detailed response to the review by Lydia N. Melek READ REVIEWER RESPONSES Introduction The global burden of dental pain significantly impacts individuals’ quality of life and can lead to costly healthcare interventions. 1 Dental pain and intraoral swelling are among the most common reasons why patients seek emergency care. 2 Dentists are among the leading antibiotic prescribers globally, contributing significantly to outpatient prescriptions. 3 International data indicate that dentists contribute approximately 7–10% of antibiotic prescriptions in primary care. 4 Antibiotics play a crucial role in managing systemic infections and preventing complications in high-risk patients, their routine use in dental pain management remains a contentious issue. 5 Antibiotic prophylaxis in dentistry helps prevent complications like dry sockets and infections, especially in high-risk patients. However, routine post-extraction antibiotic use is debated. Some argue that it aids healing and prevents infections, while others believe natural defenses suffice, even after surgery. 6 Although, While certain oro-facial infections may necessitate empirical antibiotic administration, dentists frequently prescribe antibiotics for pain management as well. 7 – 10 The overuse and misuse of antibiotics contribute significantly to antimicrobial resistance (AMR), a growing global health crisis. 11 Evidence suggests that 30% to 85% of dental antibiotic prescriptions may be unnecessary or suboptimal, raising concerns about AMR and antibiotic stewardship. 12 – 14 The World Health Organization (WHO) identifies AMR and antibiotic misuse as major global public health threats, contributing to over 6.5 million deaths annually. 15 Several systematic reviews and clinical guidelines outline the indications and efficacy of antibiotics for odontogenic infections. 16 – 20 The American Dental Association (ADA) has released guidelines on the antibiotics use for managing dental pain and swellings related to endodontic infections. 7 These evidence-based guidelines from the American Dental Association (ADA) emphasize that antibiotics should be reserved for cases involving systemic involvement and that immediate definitive conservative dental treatment should be prioritized. 7 However, due to scarcity of the systematic evidence evaluating the effectiveness of antibiotics in managing oro-facial pain. Moreover, despite existing recommendations, there is no consensus on the optimal duration of antibiotic therapy for dental infections. Some studies suggest that shorter courses (≤5 days) may be as effective as longer courses (>5 days) in achieving clinical resolution while reducing the risk of resistance, adverse effects, and healthcare costs. 21 Moreover, several studies highlight high prescription rates among dental professionals, often driven by empirical treatment rather than clinical necessity. 22 – 26 The inappropriate use of antibiotics for conditions that do not require them contributes to increased resistance, unnecessary side effects, financial burdens, and potential long-term health risks. 5 Therefore, the concept of “Rational Use of Drugs” emphasizes that medications should be prescribed based on clinical necessity, effectiveness, and cost-effectiveness. 26 However, there is insufficient evidence in dentistry to substantiate this approach. Addressing these issues require the development of evidence-based guidelines tailored to the dental profession and improved adherence to rational prescribing practices. Given the global urgency to combat AMR and improve antibiotic prescribing practices, this review aims to assess the effectiveness of short-duration (≤5 days) versus long-duration (>5 days) antibiotic therapy in patients presenting with oro-facial pain. Materials Design and registration of protocol The protocol follows the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols) guidelines. 27 PRISMA-P guidelines ensure transparency and rigor in systematic review protocols by outlining key components like objectives, search strategy, and bias assessment. They enhance clarity, minimize bias, and improve reproducibility. Using PRISMA-P helps standardize reporting, facilitating peer review and evidence-based decision-making while reducing methodological deviations. Prospective registration of the study protocol was made in PROSPERO; CRD420250610118. 28 This systematic review will answer the following research question: ‘In patients presenting with dental pain, is empiric antibiotic treatment for less than or equal to 5 days as effective as antibiotic treatment for more than 5 days? Eligibility criteria The selection of studies for this systematic review will be guided by PICOS framework (Population, Intervention, Comparison, Outcome, and Study Design), detailed as follows: Population: Individuals receiving empirical antibiotic treatment for dental pain. Intervention: Empirical antibiotics for a shorter duration (5 days). Outcomes: The primary outcomes of the study include the reduction in pain, improvement in quality of life, and assessment of adverse events associated with antibiotic use. Secondary outcomes are clinical resolution of other signs and symptoms, improvement in diagnostic parameters like microbiological tests, radiological findings, relevant biomarkers, reduction in complications, reduction in development of antibiotic resistance, cost considerations. Study design: Randomized controlled trials (RCTs) will be considered eligible. Non-randomized trials, observational studies, case reports, qualitative studies, mixed-method studies, pre-post intervention studies with or without comparators, narrative/systematic reviews, and letters to the editor will be excluded. To ensure the highest quality of evidence and reduce bias, the inclusion criteria has been limited exclusively to randomized controlled trials (RCTs), consistent with PRISMA and Cochrane guidelines. This may result in a smaller pool of eligible studies, which will be transparently reported as a limitation. In such a case, emphasis will be placed on the need for conducting future high-quality RCTs, particularly if the available trials are found to be limited in number or lacking in methodological rigor. Information sources and systematic search strategy A systematic search was conducted to determine the relevant studies published in English across four electronic databases, such as PubMed, Scopus, Cochrane Library (CENTRAL) and Embase. The search strategy utilized a blend of Medical Subject Headings (MeSH) terms, primary keywords, and standardized vocabulary, integrating the following terms: ((“dental,” “teeth,” “orofacial,” “Temporomandibular,”) AND (“pain,” “ache,” “toothache,” “analges * ”) AND (“antimicrobial,” “antibiotic”)). The vocabulary, search syntax, and study design filters were tailored and adapted to each database accordingly. The systematic search was conducted between February 1, 2025 and February 16, 2025 and was independently reviewed and cross-verified by the investigators. Detailed search strategies for each database are provided in Table 1 . Hand search will be performed to identify relevant grey literature from Google Scholar, references of selected studies and previous systematic reviews. Table 1. Search strategy. Search engine Search string Results PubMed (“dental health services”[MeSH Terms] OR (“dental”[All Fields] AND “health”[All Fields] AND “services”[All Fields]) OR “dental health services“[All Fields] OR “dental“[All Fields] OR “dentally“[All Fields] OR “dentals“[All Fields] OR (“teeth s“[All Fields] OR “teeths“[All Fields] OR “tooth“[MeSH Terms] OR “tooth“[All Fields] OR “teeth“[All Fields] OR “tooth s“[All Fields] OR “tooths“[All Fields]) OR (“teeth s“[All Fields] OR “teeths“[All Fields] OR “tooth“[MeSH Terms] OR “tooth“[All Fields] OR “teeth“[All Fields] OR “tooth s“[All Fields] OR “tooths“[All Fields]) OR “orofacial“[All Fields] OR “Temporomandibular“[All Fields]) AND (“pain“[MeSH Terms] OR “pain“[All Fields] OR (“pain“[MeSH Terms] OR “pain“[All Fields] OR “ache“[All Fields]) OR (“toothache“[MeSH Terms] OR “toothache“[All Fields] OR “odontalgia“[All Fields] OR “odontalgias“[All Fields] OR “toothaches“[All Fields]) OR “analges*“[All Fields]) AND (“anti infective agents“[Pharmacological Action] OR “anti infective agents“[MeSH Terms] OR (“anti infective“[All Fields] AND “agents“[All Fields]) OR “anti infective agents“[All Fields] OR “antimicrobial“[All Fields] OR “antimicrobials“[All Fields] OR “antimicrobially“[All Fields] OR (“anti bacterial agents“[Pharmacological Action] OR “anti bacterial agents“[MeSH Terms] OR (“anti bacterial“[All Fields] AND “agents“[All Fields]) OR “anti bacterial agents“[All Fields] OR “antibiotic“[All Fields] OR “antibiotics“[All Fields] OR “antibiotic s“[All Fields] OR “antibiotical“[All Fields])) 2810 Embase (antimicrobial:ti,ab,kw OR antibiotic:ti,ab,kw) AND (dental:ti,ab,kw OR tooth:ti,ab,kw OR teeth:ti,ab,kw OR orofacial:ti,ab,kw OR temporomandibular:ti,ab,kw) AND (pain:ti,ab,kw OR ache:ti,ab,kw OR toothache:ti,ab,kw OR analges*:ti,ab,kw) 1020 Scopus ((title-abs-key (dental) OR title-abs-key (tooth) OR title-abs-key (teeth) OR title-abs-key (orofacial) OR title-abs-key (temporomandibular))) AND ((title-abs-key (pain) OR title-abs-key (ache) OR title-abs-key (toothache) OR title-abs-key (analges*))) AND ((title-abs-key (antimicrobial) OR title-abs-key (antibiotic))) 4021 Cochrane Central (dental):ti,ab,kw OR (tooth):ti,ab,kw OR (teeth):ti,ab,kw OR (orofacial):ti,ab,kw OR (temporomandibular):ti,ab,kw AND (pain):ti,ab,kw OR (ache):ti,ab,kw OR (toothache):ti,ab,kw OR (analges*):ti,ab,kw AND (antimicrobial):ti,ab,kw OR (antibiotic):ti,ab,kw 702 Process of study selection and eligibility criteria A reference management software, Covidence will be utilized to systematically organize all retrieved studies and eliminate duplicates. 29 All search results were imported into Covidence to facilitate organization, deduplication, and efficient tracking of individual studies. In first stage (Title/Abstract Screening), a team of investigators will independently screen the titles and abstracts of retrieved citations to assess their likelihood of inclusion. In second stage (Full text screening) potentially eligible articles will undergo a duplicate independent review by the investigators, who will assess them against the predefined inclusion and exclusion criteria. Any disagreements among reviewers will be clarified through group discussions to achieve a mutual agreement. The total number of identified studies will be documented in the PRISMA flow diagram. Process of data collection and elements A pre-established data extraction form will be utilized by two independent reviewers to extract data from the eligible studies. The extracted data will include the author’s first name, date of publication, design of study, country of data collection, sample size, participant age range and mean, indication for antibiotic prescription, antibiotic name, route of administration, duration of use, use of additional analgesics, type of randomized controlled trial, and other key outcome measures. Any disagreements through the data collection process will be resolved through discussion between the independent reviewers. The corresponding authors will be contacted for missing or unclear data. If no response is received after two attempts, the article will be classified as having insufficient data and excluded. Assessment of quality of studies and certainty of evidence The Cochrane Collaboration Risk of Bias 2 (RoB 2) tool will be used to assess the methodological quality of the included randomized controlled trials. 30 This tool assesses five key domains which include randomization process, deviations from intended interventions, missing outcome data, outcome measurement, and selective reporting. Study will be classified as low risk, some concerns, or high risk of bias. The results will be visually represented using a traffic light plot and a summary table to illustrate the risk of bias across studies. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Framework 31 will be applied to determine the overall certainty of evidence. This assessment will consider risk of bias (derived from RoB 2), inconsistency (variation in results), indirectness (applicability of evidence to the research question), imprecision (confidence in effect estimates), and publication bias. Based on these factors, the evidence generated will be categorized into high, moderate, low or very low, ensuring a structured and transparent evaluation of study reliability. Any differences in data extraction will be resolved by mutual discussions. The publication bias will be assessed through funnel plots and Begg’s test if atleast 10 studies are available for meta-analysis. Data analysis and evidence synthesis Strategy for data synthesis Review Manager (RevMan) Version 5.4, The Cochrane Collaboration, 2020 will be used for the meta-analysis using odds ratio and mean difference with 95% confidence interval rates. 32 Heterogeneity will be quantified using I 2 statistic test. The fixed effects model will be preferred but wherever the value of I 2 is more than 50% and/or clinical heterogeneity is high, the random effects model will be employed. Analysis of subgroups or subsets Subgroup analysis will be employed based on age groups (Children less than 18 yrs, Adults more than equal to 18 to 60 years, geriatric more than 60 years), disadvantaged groups (Pregnant women, lactating mothers; Patients with associated co-morbidities such as immunocompromised patients, cancer patients, diabetics, patients with liver and kidney dysfunctions etc.), severity of pain (Mild/moderate/severe), origin of pain (Endodontic origin/periodontal origin/soft tissue/glandular/bony/others) and route of administration (Oral, parenteral). Ethics and dissemination Since no original data will be collected, ethical approval is not necessary. The review’s findings will be shared through publications, conference presentations, seminars, social media, and press release. Results The database search is set to start in February 2025, with data extraction from individual studies scheduled for completion by March 2025. The processes of evaluating, organizing, summarizing, and analyzing the data are expected to be concluded by April 2025, while the meta-analysis and certainty of evidence assessment is projected to be finalized by May 2025. Discussion Several systematic reviews and clinical guidelines emphasize antibiotic stewardship strategies aimed at minimizing unnecessary antibiotic use. 16 – 20 This systematic review will comprehensively assess the existing evidence on antibiotic use in the management of oro-facial pain, focusing on key outcomes such as pain relief, quality of life, adverse events, AMR, clinical resolution of signs and symptoms and cost considerations. The findings of this review will provide dental practitioners and healthcare providers with an evidence-based decision-support system regarding the appropriate indications for antibiotic use, the optimal duration of therapy, and the selection of specific antibiotics for oral disease management. Additionally, the review will generate critical evidence to inform policymakers and national and international dental organizations in the development of clinical practice guidelines for antibiotic prescription and in reinforcing antimicrobial stewardship strategies within dental settings. Given the global concern surrounding antibiotic misuse, the findings of this review will also serve as a foundation for designing educational interventions aimed at promoting rational antibiotic-prescribing behaviours among dental professionals. We anticipate potential heterogeneity among the included studies due to variations in antibiotic types, duration of use, disease conditions, and reported outcomes. To address heterogeneity, we will employ a rigorous methodological approach, including well-defined inclusion and exclusion criteria, a standardized data extraction process, and quality assessment using the Cochrane RoB 2 tool. Furthermore, subgroup analyses will be conducted based on age, disease condition, duration of antibiotic use, route of administration, and other relevant factors as needed. We expect this systematic review shall provide fresh perspectives to this field of antibiotic research in dentistry, inspiring further investigations and guiding future studies. Ethics and consent Ethical approval and consent were not required. Data availability No data associated with this article. Reporting guidelines Figshare: PRISMA-P checklist for ‘[Systematic review protocol on antibiotic use for orofacial pain: Policy and practice implications]’. https://doi.org/10.6084/m9.figshare.28682657 . 33 Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication). Acknowledgements Nil References 1. Delgado-Pérez VJ, Patiño-Marín N, Rueda-Ibarra V, et al. : Epidemiological and Oral Public Health Aspects of Dental Pain: A Narrative Review. 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Publisher Full Text Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 08 Apr 2025 ADD YOUR COMMENT Comment Author details Author details 1 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 2 Oral health Sciences Centre, Postgraduate institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 3 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India 4 Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India Nishant Mehta Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Richa Shrivastava Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Neha Patyal Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Arpit Gupta Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This research is supported by funding from the Department of Health Research, Ministry of Health and Family Welfare, Government of India [Grant number:- EM-Del/Centreforguidelines/DHR/2024]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) version 2 Revised Published: 22 Jul 2025, 14:415 https://doi.org/10.12688/f1000research.163353.2 version 1 Published: 08 Apr 2025, 14:415 https://doi.org/10.12688/f1000research.163353.1 Copyright © 2025 Mehta N et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Mehta N, Shrivastava R, Patyal N and Gupta A. Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.12688/f1000research.163353.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 2 VERSION 2 PUBLISHED 22 Jul 2025 Revised Views 0 Cite How to cite this report: Kumar SS. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.182982.r399967 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v2#referee-response-399967 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 08 Aug 2025 Sanjana Santhosh Kumar , University of Rochester, Rochester, New York, USA Approved VIEWS 0 https://doi.org/10.5256/f1000research.182982.r399967 I did go through the revised protocol. ... Continue reading READ ALL I did go through the revised protocol. It looks perfect and I’m fine with it Competing Interests: No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Kumar SS. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.182982.r399967 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v2#referee-response-399967 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 08 Apr 2025 Views 0 Cite How to cite this report: Kumar SS. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384236 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384236 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 27 May 2025 Sanjana Santhosh Kumar , University of Rochester, Rochester, New York, USA Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.179686.r384236 The topic is very relevant and important to acknowledge. The introduction is well written. The methods section is comprehensive; however, the rationale for including only randomized controlled trials (RCTs) warrants further justification, especially considering the potential scarcity of such ... Continue reading READ ALL The topic is very relevant and important to acknowledge. The introduction is well written. The methods section is comprehensive; however, the rationale for including only randomized controlled trials (RCTs) warrants further justification, especially considering the potential scarcity of such studies in the context of dental antibiotic research. Additionally, the date of the hand search has not been specified. The results of the search strategy are incomplete, as they do not provide a breakdown of the number of articles retrieved from each database until the day of submission of this protocol. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Oral health, Orthodontics, Orofacial Pain I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Kumar SS. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384236 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384236 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 09 Aug 2025 Arpit Gupta , Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India 09 Aug 2025 Author Response We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and ... Continue reading We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and align with PRISMA and Cochrane standards. We will transparently report any limitations and emphasize the need for future high-quality RCT if limited number of trials with robust methodology will be scarce. The dates of the hand search have not been specified, as this step is scheduled to be conducted in the future. The search strategy results have been updated with detailed counts from each database: PubMed (2810), Embase (1020), Scopus (4021), and Cochrane Central (702). We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and align with PRISMA and Cochrane standards. We will transparently report any limitations and emphasize the need for future high-quality RCT if limited number of trials with robust methodology will be scarce. The dates of the hand search have not been specified, as this step is scheduled to be conducted in the future. The search strategy results have been updated with detailed counts from each database: PubMed (2810), Embase (1020), Scopus (4021), and Cochrane Central (702). Competing Interests: The statement “No competing interests to disclose” has been added. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 09 Aug 2025 Arpit Gupta , Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India 09 Aug 2025 Author Response We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and ... Continue reading We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and align with PRISMA and Cochrane standards. We will transparently report any limitations and emphasize the need for future high-quality RCT if limited number of trials with robust methodology will be scarce. The dates of the hand search have not been specified, as this step is scheduled to be conducted in the future. The search strategy results have been updated with detailed counts from each database: PubMed (2810), Embase (1020), Scopus (4021), and Cochrane Central (702). We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and align with PRISMA and Cochrane standards. We will transparently report any limitations and emphasize the need for future high-quality RCT if limited number of trials with robust methodology will be scarce. The dates of the hand search have not been specified, as this step is scheduled to be conducted in the future. The search strategy results have been updated with detailed counts from each database: PubMed (2810), Embase (1020), Scopus (4021), and Cochrane Central (702). Competing Interests: The statement “No competing interests to disclose” has been added. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Melek LN. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384234 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384234 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 26 May 2025 Lydia N. Melek , Alexandria University, Alexandria, Egypt Approved VIEWS 0 https://doi.org/10.5256/f1000research.179686.r384234 The protocol is accurately designed and written following the guidelines of systematic reviews. The topic is interesting and useful for practitioners. However, I prefer adding the word "resulting from infection" to "orofacial pain" in the title. The word orofacial pain ... Continue reading READ ALL The protocol is accurately designed and written following the guidelines of systematic reviews. The topic is interesting and useful for practitioners. However, I prefer adding the word "resulting from infection" to "orofacial pain" in the title. The word orofacial pain on its own can indicate concepts different from the one meant here. Wishing the authors the best of luck with their completed research. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Oral and Maxillofacial Surgery I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Melek LN. Reviewer Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384234 ) The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384234 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 09 Aug 2025 Arpit Gupta , Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India 09 Aug 2025 Author Response We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and ... Continue reading We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” Competing Interests: The competing interests statement has also been included as ‘No competing interests to disclose’ Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 09 Aug 2025 Arpit Gupta , Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India 09 Aug 2025 Author Response We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and ... Continue reading We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” Competing Interests: The competing interests statement has also been included as ‘No competing interests to disclose’ Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 08 Apr 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 2 (revision) 22 Jul 25 read Version 1 08 Apr 25 read read Lydia N. Melek , Alexandria University, Alexandria, Egypt Sanjana Santhosh Kumar , University of Rochester, Rochester, USA Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Kumar S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 08 Aug 2025 | for Version 2 Sanjana Santhosh Kumar , University of Rochester, Rochester, New York, USA 0 Views copyright © 2025 Kumar S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I did go through the revised protocol. It looks perfect and I’m fine with it Competing Interests No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Kumar SS. Peer Review Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.182982.r399967) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-415/v2#referee-response-399967 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Kumar S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 27 May 2025 | for Version 1 Sanjana Santhosh Kumar , University of Rochester, Rochester, New York, USA 0 Views copyright © 2025 Kumar S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The topic is very relevant and important to acknowledge. The introduction is well written. The methods section is comprehensive; however, the rationale for including only randomized controlled trials (RCTs) warrants further justification, especially considering the potential scarcity of such studies in the context of dental antibiotic research. Additionally, the date of the hand search has not been specified. The results of the search strategy are incomplete, as they do not provide a breakdown of the number of articles retrieved from each database until the day of submission of this protocol. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Oral health, Orthodontics, Orofacial Pain I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 09 Aug 2025 Arpit Gupta, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India We acknowledge concerns regarding the potential scarcity of RCTs in dental antibiotic research. However, we chose to include only RCTs to synthesize the highest level of evidence, reduce bias, and align with PRISMA and Cochrane standards. We will transparently report any limitations and emphasize the need for future high-quality RCT if limited number of trials with robust methodology will be scarce. The dates of the hand search have not been specified, as this step is scheduled to be conducted in the future. The search strategy results have been updated with detailed counts from each database: PubMed (2810), Embase (1020), Scopus (4021), and Cochrane Central (702). View more View less Competing Interests The statement “No competing interests to disclose” has been added. reply Respond Report a concern Kumar SS. Peer Review Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384236) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384236 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Melek L. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 26 May 2025 | for Version 1 Lydia N. Melek , Alexandria University, Alexandria, Egypt 0 Views copyright © 2025 Melek L. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The protocol is accurately designed and written following the guidelines of systematic reviews. The topic is interesting and useful for practitioners. However, I prefer adding the word "resulting from infection" to "orofacial pain" in the title. The word orofacial pain on its own can indicate concepts different from the one meant here. Wishing the authors the best of luck with their completed research. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Oral and Maxillofacial Surgery I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (1) Author Response 09 Aug 2025 Arpit Gupta, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India We have revised the title as suggested to clarify the scope of the review. The new title is: “Systematic Review Protocol on Antibiotic Use for Infection-Related Orofacial Pain: Policy and Practice Implications.” View more View less Competing Interests The competing interests statement has also been included as ‘No competing interests to disclose’ reply Respond Report a concern Melek LN. Peer Review Report For: Systematic Review Protocol on Antibiotic Use for infection related Orofacial Pain: Policy and Practice Implications. [version 2; peer review: 2 approved] . F1000Research 2025, 14 :415 ( https://doi.org/10.5256/f1000research.179686.r384234) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-415/v1#referee-response-384234 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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