Plain English Summary
Background and study aims
Leukoplakia is a white patch in the mouth. The WHO Collaborating Centres for Oral Precancerous conditions have clinically defined the term oral leukoplakia (OL) as “white mucosal lesions that have a risk of progressing to squamous carcinoma”. To date, the term OL should be used to recognize “predominantly white plaques of questionable risk having excluded (other) known diseases or disorders that carry no increased risk for cancer”. The vast majorities of OLs are localized lesions and follow a benign course. Small subsets of these lesions can become cancerous.
The aim of this study was to assess the effectiveness of surgery in the treatment of OL, in order to compare the "wait and see" approach in term of possible malignant transformation.
Who can participate?
Caucasian patients aged 18 years or above, with OL without signs of cancer
What does the study involve?
Participants will be randomly assigned to receive either surgical removal of the OL, or treatment as usual
What are the possible benefits and risks of participating?
Where is the study run from?
CIR-Dental School, University of Turin, Italy
When is the study starting and how long is it expected to run for?
January 2012 to December 2014
Who is funding the study?
Università degli Studi di Torino (University of Turin), Italy
Who is the main contact?
Prof. Paolo G. Arduino
A randomized no intervention-controlled trial of surgery in oral leukoplakia with no dysplasia
The aim of this study is to evaluate the surgical outcome of patients diagnosed with an oral leukoplakia without dysplasia, compared to patients with the same diagnosis who did not undergo surgery
Approved 07/01/2009, CIR-Dental School (Via Nizza 230, Turin, 10126, Italy; firstname.lastname@example.org), ref: AP-RB2009/1234
Two arm randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Oral leukoplakia with no signs of dysplasia
Consecutive Caucasian patients, attending the Oral Medicine Section of the Department of Surgical Sciences, Turin Hospital, Italy, from January 2012 and December 2013, are selected for the present study. Participants are randomly divided into two groups. Allocation to treatment arms is performed using sequentially numbered randomization table. RANCODE (version 3.6) is used to generate the randomization sequence.
The first group of patients undergo surgical excision of the lesion with a traditional scalpel, (GROUP A_TS) whereas the second group of patients are followed up with no surgical session (GROUP B_NS).
The period of follow up is 5 years.
Primary outcome measure
Malignant transformation of the biopsied lesion measured using visual inspection by a physician every six months
Secondary outcome measures
Progression of the disease measured using visual inspection by a physician every six months
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Caucasian patients, attending the Oral Medicine Section of the Department of Surgical Sciences, Turin Hospital
2. Diagnosis of oral leukoplakia with no signs of dysplasia
3. Adults aged 18 and older
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Patients with a previous diagnosis of oral cancer.
2. Pregnant or lactating females; patients with incapacity to understand verbal and written instructions
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
CIR-Dental School; University of Turin
Via Nizza 230
Università degli Studi di Torino
University of Turin, 都灵大学, UNITO
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2020 results in https://pubmed.ncbi.nlm.nih.gov/32958584/ (added 02/12/2020)