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

NCT ID: NCT05215860

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-09-30

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.

Conditions

Precancerous Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Habit cessation counselling with management for OPMD

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

WHO toolkit for Tobacco cessation (5A's and 5R's model)

Habit cessation counselling, management for OPMD and intraoral photographs

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

WHO toolkit for Tobacco cessation (5A's and 5R's model)

visual exposure to personal intraoral photographs of oral lesions at baseline and review

Intervention Type: OTHER

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

Interventions

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

WHO toolkit for Tobacco cessation (5A's and 5R's model)

Intervention Type: BEHAVIORAL

visual exposure to personal intraoral photographs of oral lesions at baseline and review

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Any oral lesion suspicious of malignancy.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shalini Gupta

Additional Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalini Gupta, MDS,FDSRCS

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

Oral Medicine and Radiology, CDER, AIIMS

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

IEC-616

Identifier Type: -

Identifier Source: org_study_id