Oral Surgery Oral Medicine Oral Pathology and Oral Radiology· 2026Q2· Review
World Workshop on Oral Medicine IX: Development of a core outcome set for interventional studies on oral leukoplakia: a systematic review of outcome domains
- 1citations
- Q2SCImago
- 2026year
Short summary
A systematic review of 202 oral leukoplakia (OL) intervention studies found significant variability in outcome reporting, with clinical response, recurrence, and malignant transformation being the most common primary outcomes, and adverse events the most common secondary outcomes.
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Key points
- 202 interventional studies on oral leukoplakia (OL) were included in the systematic review.
- Clinical response (40.6%), recurrence (22.3%), and malignant transformation (22.3%) were the most frequently reported primary outcomes.
- Adverse events were the most common secondary outcome.
- Malignant transformation, a critical outcome, was reported in only 46.5% of studies and 19.1% of RCTs.
- Significant variability exists in outcome measurement and reporting across OL interventional studies.
AI-generated from the title and abstract; the full text is not read.
Abstract
Objectives To identify primary and secondary outcome measures employed in interventional studies on oral leukoplakia (OL). This systematic review is part of the broader "World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research" (WONDER) project, aimed at developing a core outcome set for reporting interventional studies on OL. Study design A systematic search of publications on OL was conducted from 1980 to March 2025, using Ovid MEDLINE, Embase, CENTRAL, CINAHL, and Clinicaltrials.gov databases, in addition to manual searching. Data on outcomes were extracted and categorized according to the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy, and the reported outcome measures were summarized. Results The search identified 6,747 records. After screening and exclusion, 202 studies were included for data extraction. Most studies were conducted in Asia and Europe, with cohort studies (48.5%) and randomized controlled trials (RCT) (23.3%) accounting for almost three quarters of all studies. Clinical response (40.6%), recurrence (22.3%), and malignant transformation (22.3%) were the most frequently reported primary outcomes, while toxicity/adverse events were the most frequent secondary outcomes. Differences in how outcomes were measured and reported across studies were noted, including differences between RCTs and case series. Furthermore, the crucial outcome of OL malignant transformation was only reported in 46.5% of studies and, more specifically, in only 19.1 % (9/47) of RCTs. Conclusions This study highlights the variability in selection and reporting of outcome measures in OL interventional studies. We recommend that, in reporting future interventional studies on OL, authors should clearly highlight the primary and secondary outcome measures used. The ability to synthesis future evidence would be greatly enhanced by the development of a core outcome set for interventional studies on oral leukoplakia.
The authors' abstract, as published at the source. Oral Surgery Oral Medicine Oral Pathology and Oral Radiology, 2026 · DOI ↗
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Field: General Dentistry
General DentistryDentistry