World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research - Core outcome set for clinical trials of burning mouth syndrome

The World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research aims to develop the core outcome set for burning mouth syndrome (BMS) clinical trials. The methodology will be guided by the work developed by the COMET initiative. We aim to conduct a systematic review (SR) summarising all the outcomes used to date in all interventional studies including randomized controlled trials (RCTs), controlled clinical trials (CCTs), observational studies and case series investigating any pharmacological (topical or systemic) or non-pharmacological treatment or intervention for the management of BMS. The SR will be followed by qualitative work, through focus groups with patients. The group of outcomes identified in these two stages will then be used to develop a Delphi survey, which will be circulated to patients, clinicians and researchers.

Finally, the outcomes identified during the Delphi survey will be presented to clinicians and researchers at the American Association of Oral Medicine conference in Las Vegas, May 2025, for ratification. The group of outcomes to be included in the COS will be finalised.

A previous project “Adopting IMMPACT recommended outcome measures in clinical trials in burning mouth syndrome: A Delphi method” had been registered in the COMET database and its first study completed and published - “World Workshop in Oral Medicine VII: Reporting of IMMPACT-recommended outcome domains in randomized controlled trials of burning mouth syndrome: A systematic review”. The results of the systematic review pointed to an underreporting of IMMPACT outcome domains in RCT of burning mouth syndrome.

The new project plans to expand on the work previously done in BMS COS by investigating all outcomes reported in all interventional studies, not exclusively on RCTs, to be as comprehensive and inclusive as possible.


Prof Lene Baad-Hansen, Aarhus University, Denmark
Dr Roddy McMillan, University College London Hospital, UK
Dr Amal Dafar, King Fahad Hospital, Saudi Arabia and University of Gothenburg, Sweden
Dr Daniela Adamo, University of Naples ”Federico II”, Italy
Dr Kununya Pimolbutr, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok, Thailand
Dr Maria Georgaki, National and kapodistrian University of Athens, Greece
Dr Carolina Venda Nova, FCS-UFP, Faculdade de Ciências da Saúde and FP-I3ID, Instituto de Investigação, Inovação e Desenvolvimento, Universidade Fernando Pessoa, Porto, Portugal
Dr Funmilola Eunice Adewinle, Department of Oral Medicine and Oral Pathology, Obafemi Awolowo University Teaching Hospital, Ile-Ife, Osun State, Nigeria
Dr Jennifer Taylor, University of Glasgow, UK
Dr Arwa Farag, King Abdulaziz University, Saudi Arabia and Tufts University, USA
Prof Richeal Ni Riordain, University College Cork, UK
Professor Jairo Robledo-Sierra, CES University, Colombia
Dr Francis O’Neill, University of Liverpool, UK
Dr Barbara Carey, Guy’s & St Thomas’s NHS Foundation Trust, London, UK
Dr Rui Albuquerque, Guy’s & St Thomas’s NHS Foundation Trust, London, UK
Dr Satu Jääskeläinen, University of Turk, Finland
Prof Richard Ohrbach, University of Buffalo, USA

Further Study Information

Current Stage: Ongoing
Date: January 2024 - May 2025
Funding source(s): The World Workshop on Oral Medicine (WWOM) IX.

Health Area

Disease Category: Dentistry & oral health

Disease Name: Burning mouth syndrome

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research


- Consensus conference
- Delphi process
- Focus group(s)
- Systematic review

- Systematic review of all outcomes published in all interventional studies in BMS (1994 to date)
- Qualitative work with patients (focus groups)
- Delphi survey with patients, clinicians and researchers
- Consensus conference

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