Diagnostic tests for oro-facial pain: protocol for a suite of systematic reviews and meta-analyses

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The overlapping clinical symptoms often complicate the diagnostic process, especially in primary care settings. While traditional methods such as symptom evaluation and basic clinical tests are routinely used, the diagnostic accuracy of these approaches remains unclear across various conditions. This underscores the need for a comprehensive evidence synthesis to evaluate the performance of clinical signs, symptoms, and point-of-care (POC) tests. Protocol This protocol outlines a suite of eight systematic reviews and meta-analyses, each focused on a specific cause of oro-facial pain: pulpal/periapical pathology, periodontal disease, temporomandibular disorders, maxillary sinusitis, neuralgias, salivary gland disorders, bone-related pathologies, and mucosal conditions. The reviews will include cross-sectional, cohort, and diagnostic randomized controlled trials that compare one or more index tests to recognized reference standards such as histological evaluation, advanced imaging, or consensus-based clinical diagnosis. A comprehensive literature search will be conducted across multiple databases. Methodological quality will be assessed using the QUADAS-2 tool, and statistical analysis will include meta-analytic models (bivariate and HSROC) to synthesize diagnostic performance measures including sensitivity, specificity, and likelihood ratios. Discussion This review suite aims to bridge the knowledge gap in diagnostic accuracy of clinical and POC tests used in the evaluation of oro-facial pain. By systematically appraising and synthesizing available evidence, the findings are expected to guide clinicians in selecting the most reliable diagnostic tools tailored to specific conditions. Ultimately, this work may support better diagnostic decision-making, reduce unnecessary interventions, and improve patient outcomes in both general and specialized dental care settings. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/14-495/v1", "name": "Diagnostic tests for oro-facial pain: protocol for a suite of systematic..." } } ] } Home Browse Diagnostic tests for oro-facial pain: protocol for a suite of systematic... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Rai A, Mahuli SA, Mahuli AV et al. Diagnostic tests for oro-facial pain: protocol for a suite of systematic reviews and meta-analyses [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :495 ( https://doi.org/10.12688/f1000research.164451.1 ) 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 Diagnostic tests for oro-facial pain: protocol for a suite of systematic reviews and meta-analyses [version 1; peer review: awaiting peer review] Arpita Rai 1 , Simpy Amit Mahuli https://orcid.org/0009-0003-0798-2000 2 , Amit Vasant Mahuli 3 , Amit Kumar 4 , Ansul Kumar 5 Arpita Rai 1 , Simpy Amit Mahuli https://orcid.org/0009-0003-0798-2000 2 , [...] Amit Vasant Mahuli 3 , Amit Kumar 4 , Ansul Kumar 5 PUBLISHED 14 May 2025 Author details Author details 1 Associate Professor, Oral Medicine and Radiology, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India 2 PhD Scholar, Dental Institute, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 3 Associate Professor, Public Health Dentistry, Dental Institute, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 4 Associate Professor, Department of Laboratory Medicine, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 5 Associate Professor, Department of Cardiothoracic and Vascular Surgery, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India Arpita Rai Roles: Conceptualization, Data Curation, Funding Acquisition, Methodology, Supervision, Validation, Writing – Review & Editing Simpy Amit Mahuli Roles: Conceptualization, Data Curation, Methodology, Resources, Validation, Visualization, Writing – Original Draft Preparation Amit Vasant Mahuli Roles: Data Curation, Formal Analysis, Methodology, Software, Supervision, Validation, Writing – Review & Editing Amit Kumar Roles: Data Curation, Formal Analysis, Methodology, Resources, Software, Visualization, Writing – Review & Editing Ansul Kumar Roles: Resources, Supervision, Visualization, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW Abstract Introduction Oro-facial pain presents a significant diagnostic challenge due to its diverse etiologies, including dental, musculoskeletal, neurological, sinus-related, and mucosal conditions. The overlapping clinical symptoms often complicate the diagnostic process, especially in primary care settings. While traditional methods such as symptom evaluation and basic clinical tests are routinely used, the diagnostic accuracy of these approaches remains unclear across various conditions. This underscores the need for a comprehensive evidence synthesis to evaluate the performance of clinical signs, symptoms, and point-of-care (POC) tests. Protocol This protocol outlines a suite of eight systematic reviews and meta-analyses, each focused on a specific cause of oro-facial pain: pulpal/periapical pathology, periodontal disease, temporomandibular disorders, maxillary sinusitis, neuralgias, salivary gland disorders, bone-related pathologies, and mucosal conditions. The reviews will include cross-sectional, cohort, and diagnostic randomized controlled trials that compare one or more index tests to recognized reference standards such as histological evaluation, advanced imaging, or consensus-based clinical diagnosis. A comprehensive literature search will be conducted across multiple databases. Methodological quality will be assessed using the QUADAS-2 tool, and statistical analysis will include meta-analytic models (bivariate and HSROC) to synthesize diagnostic performance measures including sensitivity, specificity, and likelihood ratios. Discussion This review suite aims to bridge the knowledge gap in diagnostic accuracy of clinical and POC tests used in the evaluation of oro-facial pain. By systematically appraising and synthesizing available evidence, the findings are expected to guide clinicians in selecting the most reliable diagnostic tools tailored to specific conditions. Ultimately, this work may support better diagnostic decision-making, reduce unnecessary interventions, and improve patient outcomes in both general and specialized dental care settings. READ ALL READ LESS Keywords Oro-facial pain, diagnostic accuracy, point-of-care testing, systematic review, pulpitis, temporomandibular disorders, periodontal disease, dental diagnostics Corresponding Author(s) Simpy Amit Mahuli ( [email protected] ) Close Corresponding author: Simpy Amit Mahuli Competing interests: No competing interests were disclosed. Grant information: This review is supported by the Centre for Evidence for Guidelines, Indian Council of Medical Research (ICMR), Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India, New Delhi, India The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Rai A 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: Rai A, Mahuli SA, Mahuli AV et al. Diagnostic tests for oro-facial pain: protocol for a suite of systematic reviews and meta-analyses [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :495 ( https://doi.org/10.12688/f1000research.164451.1 ) First published: 14 May 2025, 14 :495 ( https://doi.org/10.12688/f1000research.164451.1 ) Latest published: 14 May 2025, 14 :495 ( https://doi.org/10.12688/f1000research.164451.1 ) Introduction Oro-facial pain is a prevalent clinical challenge with a wide spectrum of etiologies, including pulpal and periapical pathology, periodontal disease, temporomandibular disorders (TMD), sinusitis, neuralgias, salivary gland conditions, bone-related pathology, and oral mucosal diseases. The overlapping clinical features among these conditions make diagnosis particularly complex for general dentists and clinicians in primary care settings. Despite advances in diagnostic technology, the decision-making process in clinical practice often relies on a combination of subjective symptom assessment, physical examination, and basic diagnostic tools, many of which vary significantly in their diagnostic performance. 1 – 4 The traditional approach to diagnosing oro-facial pain predominantly includes visual-tactile examination, pulp sensibility tests (e.g., thermal and electric), percussion tests, probing, and standard radiography. While these methods remain widely used, their diagnostic accuracy has not been clearly established across all etiologies. More advanced diagnostic aids, such as cone-beam computed tomography (CBCT), magnetic resonance imaging (MRI), salivary and serum biomarkers, and culture or histopathological examinations, are available but are not routinely employed due to accessibility, cost, or lack of clinical familiarity. 5 – 8 Consequently, clinicians often face uncertainty in diagnosis of orofacial pain, which may lead to empirical treatments, misdiagnosis, unnecessary interventions, or delayed care. This uncertainty underscores the urgent need for a reliable evidence base on the diagnostic accuracy of various clinical signs, symptoms, and point-of-care (POC) tests, as they compare against advanced reference standards. 1 , 3 The objective of this suite of nine systematic reviews is to evaluate the diagnostic performance of clinical symptoms, signs, clinical assessments, and POC tests done individually or in combination for various causes of oro-facial pain, using advanced diagnostic methods or consensus clinical criteria as reference standards. By synthesizing available evidence across diverse pain etiologies—including pulpal/periapical infections, periodontal disease, TMD, sinusitis, neural conditions, salivary gland disorders, bone pathologies, and mucosal conditions—this review series aims to, identify the most accurate and reliable diagnostic tools for each condition, and clarify the diagnostic pathway for clinicians working in general or primary care settings. Consequently, the goal is to equip dental practitioners with evidence-based guidance that enhances their ability to diagnose oro-facial pain accurately and efficiently. This will not only facilitate appropriate treatment planning but also reduce unnecessary interventions, improve patient outcomes, and optimize healthcare resources. Objectives This protocol was prepared in accordance with Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P). 9 Reporting guidelines. The study objectives were designed using Patient, Index test, Reference test, Target condition (PIRT) guidelines. The objective of the review is to undertake a series of reviews to establish the diagnostic accuracy of clinical signs, symptoms, and point-of-care (POC) tests for the detection and diagnosis of orofacial pain. We propose a new review for each identified origin of orofacial pain (eight reviews in total): Review 1. Diagnosis of orofacial pain due to pulpitis and/or periapical pathology ( Table 1 ) Table 1. Research Question 1. What is the performance of symptoms, signs and Point of Care (POC) tests for the diagnosis of pulpitis and/or periapical pathology in patients reporting to a healthcare setting with the complain of oro-facial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain suspected of pulpitis/peri-apical pathology Clinical sign and symptoms (alone or in combination) • History of oro-facial pain of any onset, frequency, duration, progress (intermittent/constant), type of pain (spontaneous/non-spontaneous) localized/generalized/radiating/referred pain, nocturnal pain • History of previous pain • Severity of oro-facial pain assessed by VAS/NRS/any similar criteria • Food lodgement • Pulp sensibility test- Sensitivity to hot/cold/both, Cold test done by tetrafluoroethane, carbon dioxide, ethyl chloride, propane-butane mixture or any other method, heat test done by gutta-percha; ball burnisher or any other method • Electric pulp test • Pulse oximetry • Laser doppler flowmetry • Frank cavitation/pulp exposed by caries • Oro-facial pain with Fever with or without cervical lymphadenopathy • Oro-facial pain with presence of intra-oral/extra-oral sinuses • Oro-facial pain with presence of facial swelling • Frank abscess • Depth of caries lesion • Pulp exposure during excavation, bleeding during excavation • Tooth mobility or tooth extruded • Oro-facial pain with Trismus • Tenderness to vertical percussion by a blunt instrument • Tenderness at apex on palpation • Oro-facial pain questionnaires • Bite test for fracture of tooth • Diagnostic nerve block/selective anaesthesia • Histological examination of the extracted tooth or histological examination of extirpated pulp tissue • Pulpal examination (in vivo) by access cavity preparation - visual inspection of bleeding within the pulp chamber and/or all root canals or of necrotic tissue after an access cavity was created • Advanced radiological techniques like CBCT, MRI, USG • Culture (culture of biofilm consisting of phyla namely but not limited to Actinobacteria, Bacteroidetes, Firmicutes, Fusobacteria, Proteobacteria, Spirochaetes) • Biomarker- Inflammatory biomarkers like interleukins, TNF, matrix metalloproteinase, Nitric oxide synthase, prostaglandins, osteocalcin or others • Immature teeth: radiographic examination combined with observing continued root development • Consensus diagnosis- Examination and clinical evaluation by at least two endodontic specialist/trained individual with clinical examination, and/or Radiographs (IOPA/bitewing)- ○ American Academy of Endodontics (AAE) ○ European Society of Endodontology (ESE) ○ Or any other • Composite reference standard like observation of presence/absence bleeding pulp tissue with the presence/absence of periapical radiolucency or POCs or any other Pulp vitality, pulpitis and/or periapical pathology Review 2. Diagnosis of orofacial pain due to periodontitis and/or gingivitis ( Table 2 ) Table 2. Research Question 2. What is the performance of symptoms, signs, and POC tests for the diagnosis of periodontitis and/or gingivitis in patients reporting to a healthcare setting with the complain of oro-facial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain suspected of periodontitis and/or gingivitis • History of pain in gums of any Onset, frequency, duration, progress, type of pain localized/generalized/radiating/referred pain, Pain while chewing food • Patient reported bleeding from gums • Swelling of gum • Patient reported Pus discharge from gums • Persistent bad breath/halitosis • Dentinal hypersensitivity to hot/cold • Bleeding on probing • Gingival hyperplasia • Pus discharge from gums/gingival/periodontal abscess • Dentinal hypersensitivity to hot/cold • Fever, cervical lymphadenopathy, sinuses, • Periodontal pocket formation- probing depth • Clinical Attachment Loss/Gingival recession • Pathological Migration • Tenderness to Horizontal percussion by a blunt instrument • Tooth loss due to periodontitis • Tooth mobility • Furcation involvement • Gingival and periodontal indices assessing severity of gingivitis and periodontitis (for example Gingival index, CPI, Russel’s index, CPITN) • Advanced radiologic techniques like CBCT, MRI showing bone loss • Biomarkers namely Matrix Metaloproteinase-8, Matrix Metaloproteinase-9, Interleukin-1β, Interleukin -6, Salivary free hemoglobin, Lactate dehydrogenase, BANA detected from saliva/GCF or others • Intraoperative bone loss (intraoperative measurements of the distance from CEJ to the bottom of included defects following debridement) • Culture (GCF/Saliva testing positive for periodontopathic bacteria namely Aggregatibacteractinomycetemcomitans, Porphyromonasgingivalis, Prevotella intermedia, Campylobacter, Eikenella or any other ) • Consensus diagnosis- Full-mouth clinical periodontal examination (probing pocket depth (PPD), full-mouth bleeding score (FMBS) and clinical attachment level (CAL) at six sites per tooth with/without furcation in-volvement (FI) and tooth mobility and determining the number of teeth lost due to periodontitis) by periodontal specialists ○ Centers for Disease Control and Prevention and American Academy of Periodontology (CDC/AAP) criteria ○ American Academy of Periodontology and the European Federation of Periodontology (AAP/EFP) criteria, Or any other • Composite Reference standard: CDC/AAP or AAP/EFP criteria with radiographic evidence of bone loss (IOPA/Bite wing/OPG) or any others Periodontitis and/or gingivitis Review 3. Diagnosis of orofacial pain due to temporomandibular joint ( Table 3 ) Table 3. Research Question 3. What is the performance of symptoms, signs, clinical assessments and POC tests for the diagnosis of orofacial pain affecting the temporomandibular joint in patients reporting to a healthcare setting with the chief complain of oro-facial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain suspected of Temporomandibular disorders • History of pain of any Onset, frequency, duration, progress, type of pain localized/generalized/radiating/referred pain • Aching ear pain, or ringing in the ears (tinnitus) • History of Headache, neck pain • Pain in TMJ on palpation/function/opening/examiner provocation tests • Joint noise/sounds – Clicking (classical click/reciprocal click), crepitations, popping, or grating sounds when opening or closing the mouth • Range of jaw movement - Difficulty opening or closing the mouth/Lock jaw/limited movements both passively and actively, limitations in condylar translation, and involuntary extraneous movements associated with mouth opening and closing • Tenderness, increased temperature, redness, and swelling of the TMJ • Pus discharge from TMJ • Pain/tenderness/weakness/hypertrophy in masticatory muscles • Muscle-joint palpation • Deviation/deflection of the TMJ • Trigger point identification • TMJ compression test • Dynamic and static pain tests • VAS/NRS/similar pain assessment tools • Algometry • Quantitative Sensory Testing • Diagnostic nerve block • Temporomandibular pain with Fever/cervical lymphadenopathy/sinuses/frank abscess • Clinical diagnostic indices and criteria- Fonesca Anamnestic Index, Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), anamnestic index of temporomandibular dysfunction, Clinical index of temporomandibular dysfunction, Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) or any other • Multiaxial surveys for pain • Anger/stress/anxiety assessment scales • Advanced Radiologic techniques –CBCT, MRI, USG, Radiogrpahs with TMJ views, extraoral radiographs, Radioisotope imaging, Bacterial DNA testing, or PCR for specific bacteria • Arthroscopy/Arthrography • Thermography • Electromyography • Biomarkers namely cortisol, Vitamin D, MCP-1, Cytological analyses throwing over 75% of polymorphonuclear neutrophils (PMN) and WBCover 50,000 cu/mm in the synovial fluid • Culture (TMJ aspiration testing positive for pathogenic bacteria namely Neisseria gonorrhoeae, Staphylococcus aureus, Treponema pallidum, Mycobacterium tuberculosis , Borrelia burgdorferi, Mycoplasma genitalium, Mcoplasmafermentans/oralis, Chlamydia trachomatis, Pseudomonas, E.coli, Hemophilus Influenzae etc.) • Consensus diagnosis- Examination and clinical evaluation by at least two specialists/trained individual with necessary confirmatory aids ○ Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) ○ Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) • Composite Reference standard- like clinical evaluation using (RDC/TMD)/ (DC/TMD) with the presence/absence of radiologic findings or POCs or any other Disc displacement, Myofacial Pain Dysfunction Syndrome, Osteoarthritis Review 4. Diagnosis of orofacial pain due to maxillary sinusitis ( Table 4 ) Table 4. Research Question 4. What is the performance of symptoms, signs, clinical assessments and POC tests for the diagnosis of maxillary sinusitis in patients reporting to a healthcare setting with orofacial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain suspected of sinusitis Clinical signs and symptoms (alone or in combination): • History of facial pain or pressure (unilateral or bilateral), Increased pain upon bending forward • History of flu-like symptoms • History of Nasal congestion or obstruction or Postnasal drip or Purulent nasal discharge (anterior/posterior) or Persistent bad breath/Halitosis • Oro antral communication • Hyposmia or anosmia • Palpation finding: Swelling, tenderness, or erythema over affected sinus areas • Sinus percussion • Mucosal edema or erythema on anterior rhinoscopy • Presence of nasal polyps or deviated nasal septum • Transillumination test findings (diminished or absent light transmission over maxillary sinuses) • Clinical diagnostic criteria (e.g., EPOS, AAO-HNS guidelines) Symptom duration (acute, subacute, chronic, or recurrent sinusitis classification • Histopathological diagnosis • Advanced Radiologic Techniques: ○ Computed Tomography (CT) of paranasal sinuses (for sinus opacification, air-fluid levels, mucosal thickening)/CBCT/3d slicer volumetric segmentation (Automatic segmentation) ○ PET scan (positron emission tomography) ○ Magnetic Resonance Imaging (MRI) for complicated cases (e.g., orbital or intracranial involvement) ○ Ultrasonography for maxillary sinus fluid accumulation ○ Radiography (Waters' view, Caldwell view for sinus opacity, air-fluid levels) • Nasal endoscopy (mucosal edema, purulence, polyps, anatomical abnormalities) • Mucociliary clearance tests • Biomarkers (elevated inflammatory markers such as CRP, ESR, or cytokines in sinus aspirates) • Microbiological culture (sinus aspiration testing positive for pathogenic bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Pseudomonas aeruginosa , or Anaerobes ) • PCR or bacterial DNA testing for sinus pathogens • Consensus diagnosis: Examination and clinical evaluation by at least two specialists/trained individuals with necessary confirmatory diagnostic aids ○ Diagnostic guidelines defined by ○ Clinical Practice Guideline: Adult Sinusitis 2007 ○ Standards of Care Committee of the British Society for Allergy and Clinical Immunology 2008 ○ European Position Paper on Rhinosinusitis and Nasal Polyps 2007 ○ Joint Task Force on Practice Parameters 2005 ○ Rhinosinusitis Initiative 2004 • Composite reference standard: Clinical diagnosis by diagnostic guidelines with POCs or any other Maxillary sinusitis Review 5. Diagnosis of orofacial pain of neural origin ( Table 5 ) Table 5. Research question 5. What is the performance of symptoms, signs, clinical assessments and POC for the diagnosis of neural pain in patients reporting to a healthcare setting with complaints of orofacial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain suspected of be of neural origin Clinical signs and symptoms (alone or in combination): • History of sharp, shooting, or burning pain in the orofacial region, Paroxysmal or continuous pain episodes, Pain triggered by touch, chewing, talking, or temperature changes • Dysesthesia, hyperalgesia, or allodynia in affected areas • Clinical examination along the course of affected nerves - Localized swelling, redness, warmth in affected regions, Tenderness (e.g., trigeminal nerve, facial nerve, glossopharyngeal nerve), Pus discharge or abscess formation near affected nerves • Muscle weakness or paralysis in the orofacial region • Orofacial pain with or without autonomic symptoms (lacrimation, rhinorrhoea, facial flushing, ptosis, or miosis) • Orofacial pain with or without presence of systemic infection signs such as fever, fatigue, or malaise or Cervical lymphadenopathy • Neurological examination (like decreased or altered sensation, loss of corneal reflex, or asymmetric facial movement) • Psychological distress evaluation (stress, anxiety, depression scales related to chronic pain) • Hot and cold tests • Quantitative sensory testing (QST) • Diagnostic nerve blocks to differentiate neural pain from other causes • Histopathologic examination • Radiographic Techniques: ○ Magnetic Resonance Imaging (MRI) for nerve inflammation, abscess formation, or compressive pathology ○ Computed Tomography (CT) scan for bony involvement and infection spread ○ High-resolution ultrasonography (HRUS) for nerve swelling or abscess detection ○ Radionuclide imaging for detecting areas of increased metabolic activity due to infection • Nerve conduction studies (NCS) • Electromyography (EMG) for neural dysfunction assessment • Biomarker analysis (elevated inflammatory markers such as CRP, ESR, cytokines in cerebrospinal fluid or blood) • Consensus diagnosis: Examination and clinical evaluation by at least two specialists/trained individuals with necessary confirmatory diagnostic criteria • Composite reference standard: clinical evaluation with neurological examination and POCs and any other finding • Microbiological culture (nerve aspiration or tissue biopsy testing positive for pathogenic bacteria such as Staphylococcus aureus, Streptococcus species, Mycobacterium tuberculosis, Treponema pallidum, Borrelia burgdorferi, Mycoplasma, Pseudomonas aeruginosa, Escherichia coli ) PCR or bacterial DNA testing from nerve aspirates Trigeminal neuralgia, Bell’s palsy, Post-herpetic neuralgia Review 6. Diagnosis of orofacial pain due to salivary gland conditions ( Table 6 ) Table 6. Research Question 6. What is the performance of symptoms, signs, clinical assessments and POC for the diagnosis of salivary gland conditions in patients presenting to a healthcare setting with complaints of orofacial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oro-facial pain affecting the salivary glands Clinical signs and symptoms (alone or in combination): • History of Swelling, tenderness, or erythema of the affected salivary gland (parotid, submandibular, sublingual) • History of oro-facial pain of any onset, frequency, duration, progress (intermittent/constant), type of pain (spontaneous/non-spontaneous) localized/generalized/radiating/referred pain • Purulent discharge from the salivary duct upon massage • Dry mouth or altered saliva consistency • Fever and systemic signs of infection (malaise, chills, fatigue) • Difficulty in mastication, swallowing, or speaking • Palpable firm or fluctuant mass in the glandular region • Regional lymphadenopathy • Halitosis (bad breath) associated with infection • Sialolith • Pain intensity assessment using Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) • Fine-needle aspiration cytology (FNAC) for bacterial identification and inflammatory cell analysis • Histopathological diagnosis • Advanced Radiologic Techniques: ○ Sialography to evaluate ductal obstruction or structural abnormalities ○ Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan for deep-seated infections and sialolithiasis • Ultrasonography (USG) for glandular swelling and abscess formation • Biomarker: Salivary biomarker analysis (elevated inflammatory markers such as IL-1β, TNF-α, MMP-8, and CRP) • Blood investigations (CBC, ESR, CRP) to assess systemic involvement • Consensus diagnosis: Examination and clinical evaluation by at least two specialists/trained individuals with necessary confirmatory diagnostic aids • Composite reference standard: Clinical evaluation with other diagnostic aids or POCs • Microbiological culture (salivary gland aspirate, pus, or ductal discharge testing positive for pathogenic bacteria such as Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridians, Haemophilus influenzae, Actinomyces israelii, Fusobacterium nucleatum, Pseudomonas aeruginosa, Escherichia coli ) • PCR or bacterial DNA testing from glandular aspirates Sialadenitis Review 7. Diagnosis of orofacial pain originating from bone (maxilla or mandible) ( Table 7 ) Table 7. Research Question 7. What is the performance of symptoms, signs, clinical assessments and POC for diagnosing bone conditions in patients presenting with orofacial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with orofacial pain originating form maxilla or mandible Clinical signs and symptoms (alone or in combination): • History of oro-facial pain of any onset, frequency, duration, progress (intermittent/constant), type of pain (spontaneous/non-spontaneous) localized/generalized/radiating/referred pain, • Throbbing, dull, or sharp pain localized to the jaw or affected facial area • Pain exacerbation with mastication or palpation • Tenderness on palpation over the affected bone region • Swelling, erythema, and increased temperature over the bone or adjacent soft tissue • Presence of sinus tracts or fistulae suggesting chronic infection • History of oro-facial pain with regional lymphadenopathy • Visible bone changes such as lucency, sequestra formation, cortical erosion, or periosteal reactions on conventional radiographs • Extraoral signs such as facial asymmetry or trismus • Use of clinical diagnostic criteria (e.g., any standardized criteria for diagnosing osteomyelitis) in conjunction with pain assessment scales (Visual Analog Scale, Numerical Rating Scale) • Histopathological diagnosis • Advanced Diagnostic Techniques: Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) to delineate the extent of bone involvement and detect sequestra or abscess formation • Radionuclide bone scanning to evaluate metabolic activity in suspected areas • Biomarker Analysis: Assessment of systemic inflammatory markers (e.g., elevated ESR, CRP, leukocyte counts) in conjunction with clinical findings • Consensus Diagnosis: Diagnosis based on comprehensive evaluation by at least two specialists (oral/maxillofacial surgeons, radiologists, infectious disease experts) • Composite reference standard: Clinical diagnosis with confirmatory aids or POCs or any other • Microbiological Culture: Bone biopsy, curettage, or aspirate yielding a positive culture for pathogenic bacteria (e.g., Staphylococcus aureus, Streptococcus species, Actinomyces, anaerobic bacteria ) Osteomyelitis, Osteoradionecrosis Review 8. Diagnosis of orofacial pain due to oral mucosal conditions ( Table 8 ) Table 8. Research Question 8. What is the performance of symptoms, signs, clinical assessments and POC for diagnosing oral mucosal conditions in patients presenting with orofacial pain? Population (P) Index test (I) Reference standard (Any) (R) Target condition (T) General population (any age, gender) with permanent/deciduous teeth presenting with oral mucosal conditions Clinical signs and symptoms (alone or in combination): • Clinical signs and symptoms observed during conventional oral examination may include, but are not limited to: • History of oro-facial pain of any Onset, frequency, duration, progress, type of pain localized/generalized/radiating/referred pain • History of Altered sensation (numbness, dysesthesia) around the affected mucosa • History of persistent bad breath/halitosis linked to the infection • Regional swelling and increased local temperature • Fever, Cervical lymphadenopathy • Erythema, ulceration, or white/yellow plaques on the oral mucosa • Induration or necrosis of the mucosal tissue • Presence of exudate or purulent discharge from mucosal lesions • Vesicles, erosions, hemorrhagic crusts, petechiae, purpura, erythema • Mucoscopy • Use of pain assessment tools such as the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) • Application of clinical diagnostic criteria to categorize the lesion severity • Histopathological examination of biopsy samples • Imaging studies (where applicable) such as digital radiography • Biomarkers: Assessment of immunological or salivary biomarkers (e.g., elevated levels of inflammatory cytokines such as IL-1β, TNF-α, or CRP) • Consensus Diagnosis: Evaluation by at least two specialists (such as oral medicine experts and infectious disease clinicians) using comprehensive clinical information • Composite Reference standard: Clinical evaluation with other diagnostic aids or PoCs • Microbiological Culture and Sensitivity Testing: Obtaining an oral mucosal swab, tissue biopsy, or aspirate that yields a positive culture for pathogenic micro-organism • Polymerase Chain Reaction (PCR) or bacterial DNA testing for pathogen identification Ulcerative/vesiculobullous lesions, Burning mouth syndrome, Oral lichen planus/lichenoid reactions, OSMF, Oral candidiasis Aligned to the objectives listed above, the specific research questions answered through the suite of systematic reviews are listed in Tables 1 through 8 . Methods Eligibility criteria: We will include • Retrospective/prospective cross sectional and cohort studies that evaluate the diagnostic accuracy of single index tests as well as studies that directly compare two or more index tests, • Studies that evaluate test combinations alone or test combinations in comparison to a single test or other test combinations, • Randomised controlled trials (RCTs) of the diagnostic test accuracy of one or more index tests in comparison to a refence test. Information sources and search strategy We will search PubMed, EMBASE, the Cochrane Library and SCOPUS for the eligible studies from inception to April 2025. The PubMed search strategy will be structured to ensure comprehensive retrieval of relevant studies related to the diagnostic performance of clinical assessments and Point of Care (POC) tests for the target conditions. The search will incorporate terms related to “diagnostic test accuracy,” “diagnostic accuracy,” “odds ratios,” “likelihood ratio,” “positive predictive value,” and “negative predictive value,” combined with specific conditions of interest. These conditions will include pulpitis, pulp exposure, pulp disease, periapical abscess, periapical pathology, gingivitis, periodontitis, temporomandibular infections, sinusitis, bacterial neuralgia, osteomyelitis of the jaw, and oral bacterial infections. Boolean operators (AND/OR) will be used to optimize search sensitivity and specificity. Filters such as “English language,” “human studies,” and the exclusion of systematic reviews, meta-analyses, and review articles will be applied to refine the results. Additional searches will be conducted in Cochrane, Embase and SCOPUS using similar terms, to ensure comprehensive coverage. The strategy will be iteratively refined to capture the most relevant literature while minimizing irrelevant results. The detailed search strategy can be accessed through the supplementary file. Study selection The search results will be uploaded on Covidence systematic review software for screening. The results of all searches will be screened and assessed independently by two review authors for inclusion. Any disagreements will be resolved through discussion and, if necessary, consultation with another clinical or methodological member of the author team. Studies will be excluded if the data are not presented in the format of a 2 x 2 contingency table or data regarding Diagnostic Accuracy Metrics is not reported. A PRISMA flowchart will be used to report the study selection process. Once agreement on inclusion is reached, the studies will be categorized according to their index test, dental disease and reference test. Data extraction Data will be extracted independently and in duplicate by two review authors using a piloted data extraction form based on the review inclusion criteria. Any disagreements will be resolved through discussion by the review team. Where data are reported for multiple index or refence tests, they will be extracted separately for each. Study authors will be contacted to obtain missing data or clarify characteristics not evident in the published paper. The following data will be recorded for each study: • Sample characteristics (age, gender, condition); • Setting (country, disease prevalence, type of facility); • Study information (design, reference standard, case definition, training and calibration of personnel); • The type of index test(s) used (category, name, conditions, thresholds, if any); • The type of refence test(s) used (category, name, conditions, thresholds, if any); • Study results (true positive, true negative, false positive, false negative, any equivocal results, withdrawal). Risk of bias (quality) assessment We will use the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) to assess the risk of bias and applicability of the primary diagnostic studies across the four domains of participant selection, index test, reference standard, and flow and timing (Whiting 2011). A customized QUADAS tool will be prepared for the present systematic review. Quality assessment will be done independently by two review authors. Any disagreements will be resolved through discussion by the review team. Strategy for data synthesis The primary outcomes of interest will be true positive, true negative, false positive, false negative, sensitivity and specificity of the index tests. Secondary outcomes might include positive and negative likelihood ratios, diagnostic odds ratios (DORs), and the area under the summary receiver operating characteristic curve (AUC). Meta-analysis Where appropriate, and if enough comparable studies are identified, we will conduct a meta-analysis. A bivariate random-effects model may be used to jointly synthesize sensitivity and specificity estimates, accounting for within- and between-study variability and the potential correlation between the two measures. Summary point estimates will be presented with 95% confidence intervals. In cases where diagnostic thresholds vary substantially across studies, we will apply a hierarchical summary receiver operating characteristic (HSROC) model to explore threshold effects and to generate a summary ROC curve. This model will allow us to assess the influence of study-level covariates and estimate the area under the curve (AUC) as an overall measure of test performance. Assessment of heterogeneity We will assess heterogeneity visually through forest plots and SROC curves, and statistically by examining the variance of logit-transformed sensitivity and specificity estimates. Where substantial heterogeneity is suspected, we will explore potential sources using subgroup analysis or meta-regression, depending on the availability and quality of study-level data. Subgroup and sensitivity analyses Subgroup analyses may be conducted based on factors such as the type of diagnostic test (e.g., thermal, electric, percussion, or imaging), and the methodological quality of included studies as assessed by the QUADAS-2 tool. Sensitivity analyses might be performed to evaluate the robustness of the results by excluding studies at high risk of bias, small studies (e.g., fewer than 50 participants), or studies using unclear reference standards. Assessment of reporting bias If ten or more studies are included in each test comparison, we will assess potential reporting bias using Deeks’ funnel plot asymmetry test. A statistically significant non-zero slope might suggest the presence of publication bias. Software Statistical analyses will be performed using appropriate software. RevMan 5 may be used for basic forest plots and data management, while Stata18 (e.g., using the MIDAS or METANDI commands) will be employed for fitting bivariate and HSROC models. GRADE assessment We will use the GRADE approach adapted for diagnostic test accuracy studies to assess the certainty of the evidence for each diagnostic modality. Summary of Findings tables will be developed to present key results, incorporating evaluations of risk of bias, inconsistency, indirectness, imprecision, and publication bias. Discussion The complexity of diagnosing oro-facial pain lies in its multifactorial etiology and the substantial overlap in clinical presentations among various conditions. General practitioners and primary care dentists often rely on traditional diagnostic methods such as symptom assessment, visual-tactile examination, and basic radiography. However, the diagnostic accuracy of these tools varies widely, which can lead to misdiagnosis, unnecessary interventions, and delayed treatment. This protocol addresses a critical gap in clinical practice by proposing a structured evaluation of the diagnostic performance of commonly used clinical signs, symptoms, and point-of-care tests across a wide spectrum of oro-facial pain conditions. By employing systematic review and meta-analytic methods, this suite of reviews aims to generate robust, evidence-based guidance that clinicians can apply in real-world settings. Importantly, the protocol also highlights the growing availability of advanced diagnostic modalities such as cone-beam computed tomography, MRI, and biomarker-based testing. While these techniques show promise in improving diagnostic precision, their accessibility and cost may limit their routine use. By comparing these methods to traditional and POC tests, the review series may help define a more practical and cost-effective diagnostic workflow. Overall, this work has the potential to enhance diagnostic confidence among clinicians, reduce the burden of diagnostic uncertainty, and ultimately improve outcomes for patients suffering from oro-facial pain. Study status This systematic review is presently undergoing screening of articles. The protocol for this systematic review has been registered with PROSPERO in December, 2024 (CRD42024617050). Reporting guidelines Figshare: PRISMA-P-checklist for manuscript titled DIAGNOSTIC TESTS FOR ORO-FACIAL PAIN: PROTOCOL FOR A SUITE OF SYSTEMATIC REVIEWS AND META-ANALYSES. DOI: https://doi.org/10.6084/m9.figshare.28831526 10 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Ethics, consent and dissemination Ethical approval and consent was not required in this study because no data are related to an individual patient. The results will be disseminated through peer-reviewed publications. Data availability No data are associated with this article. Extended data No extended data. References 1. Balasubramaniam R, Klasser GD: Dental (Odontogenic) Pain. J. Can. Dent. Assoc. 2014; 80 : e30. Reference Source 2. Hargreaves KM, Berman LH: Oral Diagnosis: Diagnosing the Patient in Pain. Cohen's Pathways of the Pulp. St. Louis: Mosby Elsevier; 11th ed.2016; 2–26. 3. Renton T, Durham J, Aggarwal VR: Diagnosis and treatment of abnormal oro-facial pain including atypical odontalgia and phantom tooth pain: A review. J. Oral Rehabil. 2012 May; 39 (5): 277–284. Publisher Full Text 4. Nixdorf DR, Moana-Filho EJ, Law AS, et al. : Frequency of nonodontogenic pain after endodontic therapy: A systematic review and meta-analysis. J. Endod. 2010 Sep; 36 (9): 1494–1498. PubMed Abstract | Publisher Full Text | Free Full Text 5. Levin LG, Law AS, Holland GR, et al. : Identify and define all diagnostic terms for pulpal health and disease states. J. Endodont. 2009 Dec; 35 (12): 1645–1657. PubMed Abstract | Publisher Full Text 6. Zakrzewska JM, McMillan R, Chambers WA: Differential diagnosis of facial pain and guidelines for management. Br. J. Anaesth. 2013 Jul; 111 (1): 95–104. PubMed Abstract | Publisher Full Text 7. Sessle BJ: The neural basis of temporomandibular joint and masticatory muscle pain. J. Orofac. Pain. 1999; 13 (4): 238–245. PubMed Abstract 8. Baad-Hansen L, Pigg M, Ivanovic SE, et al. : Intraoral somatosensory abnormalities in patients with atypical odontalgia: a controlled multicenter quantitative sensory testing study (allodynia). Pain. 2013 Jun; 154 (6): 1287–1294. PubMed Abstract | Publisher Full Text | Free Full Text 9. Shamseer L, Moher D, Clarke M, et al. : Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2; 349 :g7647. PubMed Abstract | Publisher Full Text 10. Mahuli S: PRISMA -P checklist for manuscript titled “DIAGNOSTIC TESTS FOR ORO-FACIAL PAIN: PROTOCOL FOR A SUITE OF SYSTEMATIC REVIEWS AND META-ANALYSES.” Dataset. figshare. 2025. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 May 2025 ADD YOUR COMMENT Comment Author details Author details 1 Associate Professor, Oral Medicine and Radiology, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India 2 PhD Scholar, Dental Institute, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 3 Associate Professor, Public Health Dentistry, Dental Institute, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 4 Associate Professor, Department of Laboratory Medicine, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India 5 Associate Professor, Department of Cardiothoracic and Vascular Surgery, Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, India Arpita Rai Roles: Conceptualization, Data Curation, Funding Acquisition, Methodology, Supervision, Validation, Writing – Review & Editing Simpy Amit Mahuli Roles: Conceptualization, Data Curation, Methodology, Resources, Validation, Visualization, Writing – Original Draft Preparation Amit Vasant Mahuli Roles: Data Curation, Formal Analysis, Methodology, Software, Supervision, Validation, Writing – Review & Editing Amit Kumar Roles: Data Curation, Formal Analysis, Methodology, Resources, Software, Visualization, Writing – Review & Editing Ansul Kumar Roles: Resources, Supervision, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This review is supported by the Centre for Evidence for Guidelines, Indian Council of Medical Research (ICMR), Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India, New Delhi, India The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 14 May 2025, 14:495 https://doi.org/10.12688/f1000research.164451.1 Copyright © 2025 Rai A 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. 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Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 May 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status AWAITING PEER REVIEW 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 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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