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

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Precancerous Conditions

Treatments: Other: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT05215860

IEC-616

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current tobacco and areca nut users.
• Presence of oral potentially malignant disorders

Exclusion criteria

• Any oral lesion suspicious of malignancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Habit cessation counselling with management for OPMD

Active Comparator group

Description:

n=100; Habit cessation counselling with general and medical management for OPMD

Treatment:

Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders

Habit cessation counselling, management for OPMD and intraoral photographs

Experimental group

Description:

n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review

Treatment:

Other: 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