Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates

Study Overview
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Brief Summary
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The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. A prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and OPMD were randomly divided in two groups. Group A ( n=100; Habit cessation counselling with general and medical management for OPMD). Group B ( n=100; Habit cessation counselling with general and medical management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review).

Detailed Description
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A prospective pilot interventional study was carried out in a Oral Medicine unit at a tertiary referral center where OPMD and Oral cancer screening is carried out routinely in all patients examined in the Out Patient Department (OPD). Ethical clearance for conducting the study and taking serial intraoral photographs of OPMD in consenting participants was obtained from the Institute Ethics Committee.All patients in OPD were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the Tobacco Cessation Clinic (TCC) for individual counselling session.This counselling was based on the toolkit issued by the World Health Organization (WHO) for delivering brief tobacco intervention under WHO capacity building training package.The patients then underwent detailed intraoral examination for any oral mucosal changes. Those patients that were diagnosed as having any OPMD as per clinical diagnostic criteria were then recruited as participants in the study. A total of 200 participants with current tobacco and areca nut habits and OPMDs were recruited after informed written consent and randomly assigned to the two groups. The Control Group A had 100 participants who received standard management protocol for OPMD. The experimental Group B received all the management as in Control Group A but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. All the participants were reviewed at 1, 3 and 6 months for surveillance of OPMD lesions and habit status.The data was analysed for statistically significant differences between the two groups p<0.05.

Official Title
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Visual Communication Through Personal Intraoral Photographs of Oral Potentially Malignant Disorders in Current Tobacco and Areca Nut Users Improves Habit Abstinence: a Pilot Interventional Study

Conditions
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Precancerous Conditions

Intervention / Treatment
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* Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders
* Other: visual exposure to personal intraoral photographs of oral lesions at baseline and review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current tobacco and areca nut users. Presence of oral potentially malignant disorders Exclusion Criteria: • Any oral lesion suspicious of malignancy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective pilot interventional longitudinal study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Habit cessation counselling with management for OPMD<br>n=100; Habit cessation counselling with general and medical management for OPMD | Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders<br>* WHO toolkit for Tobacco cessation (5A's and 5R's model)<br>|
| Experimental: Habit cessation counselling, management for OPMD and intraoral photographs<br>n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review | Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders<br>* WHO toolkit for Tobacco cessation (5A's and 5R's model)<br>Other: visual exposure to personal intraoral photographs of oral lesions at baseline and review<br>* Chairside digital intraoral photographs of oral potentially malignant disorder with smart phone and showing the photograph to the participant explaining the abnormal areas of concern<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Habit quit rates | Discontinuation of habit more than 1 month. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of oral lesions | Change in size of lesions from baseline in millimeters | 6 months | 
| Oral burning sensation | Change in oral burning sensation from baseline Visual Analogue Scale (VAS) scale 0-10; 0: No oral burning sensation; 10: Worst oral burning sensation | 6 months | 
| Colour of oral lesions | Change in colour of oral lesions from red to white | 6 months | 
| Inter incisal mouth opening | Change in interincisal mouth opening from baseline in millimeters | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cessation, tobacco use, smokeless tobacco, areca, intraoral photography, abstinence