Core Outcome Measures in Effectiveness Trials

World Workshop on Oral Medicine VII: Burning mouth syndrome: A systematic review of disease definitions and diagnostic criteria utilized in randomized clinical trials

General Information

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.

Ariyawardana, A. Chmieliauskaite, M. Farag, A. M. Albuquerque, R. Forssell, H. Nasri-Heir, C. Klasser, G. D. Sardella, A. Mignogna, M. D. Ingram, M. Carlson, C. R. Miller, C. S.


Oral Dis
25 Suppl 1
141 - 156
Further Study Information

- October 2017
Funding source(s):
The WWOM VII Steering Committee gratefully acknowledges the following organizations and companies that provided financial support for WWOM VII: American Academy of Oral Medicine, European Association of Oral Medicine, The British Society for Oral Medicine, Oral Diseases, Henry Schein Cares Foundation, Colgate Palmolive, Xerostom, Afyx, The World Dental Education Foundation, and Unilever.

Health Area

Disease Category
Dentistry & oral health

Disease Name
Burning mouth syndrome

Target Population

Age Range


Nature / type of Intervention


Systematic review

Stakeholders Involved


Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

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