Clinical trial NCT05215860: Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Conditions
Keywords: cessation
tobacco use
smokeless tobacco
areca
intraoral photography
abstinence
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective pilot interventional longitudinal study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Any oral lesion suspicious of malignancy.

Primary outcomes:
measure: Habit quit rates
timeFrame: 6 months
Secondary outcomes:
measure: Size of oral lesions
timeFrame: 6 months
measure: Oral burning sensation
timeFrame: 6 months
measure: Colour of oral lesions
timeFrame: 6 months
measure: Inter incisal mouth opening
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Oral Medicine and Radiology, CDER, AIIMS
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Shalini Gupta, MDS,FDSRCS
role: PRINCIPAL_INVESTIGATOR
References: