Objective To conduct a systematic review analyzing disease definitions and diagnostic criteria used in randomized controlled trials (RCTs) involving burning mouth syndrome (BMS). Methods A systematic search conducted in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar that included RCTs on BMS published between 1994 and 2017 was performed. Results Considerable variability in BMS disease definitions and diagnostic criteria used created substantial heterogeneity in the selection of participants and weakened the rigor of the 36 RCTs identified. The analyzed RCTs routinely under‐reported the methods used to rule in or out study participants and the number of individuals excluded from BMS RCTs. Conclusions Our findings indicate that a large proportion of participants enrolled in these studies may have had an underlying condition that could have explained their BMS symptoms. Thus, outcomes of therapeutic interventions from these BMS RCTs should be interpreted with caution due to heterogeneous disease definitions and diagnostic criteria. In order to improve the quality of clinical trials, future research should focus on establishing consensus for a single definition of BMS that includes specific inclusion and exclusion criteria that should be used to select study participants for clinical trials.

Objectives To determine the frequency of use of the core outcome domains published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in burning mouth syndrome (BMS) randomized controlled trials (RCTs). Methods This systematic review, conducted as part of the World Workshop on Oral Medicine VII (WWOM VII), was performed by searching the literature for studies published in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar from January 1994 (when the first BMS definition came out) through October 2017. Results A total of 36 RCTs (n = 2,175 study participants) were included and analyzed. The overall reporting of the IMMPACT core and supplemental outcome domains was low even after the publication of the IMMPACT consensus papers in 2003 and 2005 (mean before IMMPACT consensus publication = 2.6 out of 6; mean after IMMPACT publication = 3.8 out of 6). Use of validated assessment tools recommended by the IMMPACT consensus was scarce (1.9 out of 6). None of the RCTs reviewed cited the IMMPACT consensus papers. Conclusions The underreporting of IMMPACT outcome domains in BMS RCTs is significant. Raising awareness regarding the existence of standardized outcome domains in chronic pain research is essential to ensure more accurate, comparable, and consistent interpretation of RCT findings that can be clinically translatable.

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Central giant cell granuloma (CGCG) is a benign non-neoplastic, proliferative intraosseous lesion of the jaw with an unknown etiology often diagnosed during the first two decades of life. The true nature of this lesion is controversial and remains elusive. Here, we report a case of central giant cell granuloma, diagnosed using cone-beam computed tomography (CBCT). A 21-year-old female presented to the clinic complaining of a painless swelling involving the right side of the mandible that had started one year previously. A CBCT scan revealed a well-defined, multilocular radiolucent lesion on the right side of the mandible extending from the molar region to the ramus with wispy septations. Wispy septations and undulating borders are some of the characteristic radiographic features of a central giant cell granuloma. The patient underwent an excisional biopsy. The biopsy revealed multinucleated giant cells in a fibrous stroma confirming our radiographic diagnosis of a central giant cell lesion.

The International Classification of Diseases (ICD-11) proposes revisions in the nomenclature, disease definition, and diagnostic criteria for “burning mouth syndrome” (BMS). This process could benefit from additional systematically collected expert input. Thus, the purpose of this study was to use the Delphi method to (1) determine whether revision in nomenclature and alternative names for “BMS” are warranted and (2) identify areas of consensus among experts for changes to the disease description and proposed diagnostic criteria of “BMS,” as described in the ICD-11 (World Health Organization). From 31 international invited experts, 23 who expressed interest were sent the survey. The study used 4 iterative surveys, each with a response rate of ≥82%. Consensus was predefined as 70% of participants in agreement. Data were summarized using both descriptive statistics and qualitative thematic analysis. Consensus indicated that BMS should not be classified as a syndrome and recommended instead renaming to “burning mouth disorder.” Consensus included deletion of 2 diagnostic criteria: (1) emotional distress or functional disability and (2) the number of hours symptoms occur per day. Additional items that reached consensus clarified the disease definition and proposed more separate diagnostic criteria, including a list of local and systemic factors to evaluate as potential secondary causes of oral burning. Experts in this study recommended and came to consensus on select revisions to the proposed ICD-11 BMS nomenclature, diagnostic criteria, and disease definition. The revisions recommended have the potential to improve clarity, consistency, and accuracy of diagnosis for this disorder.

No abstract

Objectives To determine the effectiveness of systemic pharmacotherapeutic interventions compared to placebo in burning mouth syndrome (BMS) randomized controlled trials (RCTs) based on the core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Methods A systematic literature review of RCTs, concerning systemic pharmacotherapeutic interventions for BMS, published from January 1994 through October 2019, and meta‐analysis was performed. Results Fourteen RCTs (n = 734 participants) were included. Of those, nine were eligible for the quantitative assessment due to the availability/homogeneity of data for at least one of the IMMPACT domains. Pain intensity was the only domain reported in all RCTs. Weighted mean changes in pain intensity, based on visual analogue scale (ΔVAS), were reported in three RCTs at 6 ± 2 weeks and only one RCT at 10+ weeks follow‐ups. Quantitative assessment, based on ΔVAS, yielded very low evidence for the effectiveness of alpha‐lipoic acid and clonazepam, low evidence for effectiveness of trazodone and melatonin, and moderate evidence for herbal compounds. Conclusions Based on the RCTs studied, variable levels of evidence exist that suggest that select pharmacological interventions are associated with improved symptoms. However, the underreporting of IMMPACT domains in BMS RCTs restricts the multidimensional assessment of systemic interventions outcomes. Standardized outcome measures need to be applied to future RCTs to improve understanding of intervention outcomes.

Background: A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized IMMPACT core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice. Methods: A BMS-specific COS will be developed using the method recommended by the Core Outcome Measures in Effective Trials (COMET) initiative (Registration: http://www.comet-initiative.org/studies/details/1357). Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of RCTs in BMS conducted by the consortium. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalized COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting. Discussion: A COS for the management of BMS will improve the quality of future RCTs, reduce outcome reporting heterogeneity, and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure enhanced quality evidence for clinical management of the condition.