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Completed

NCT Number: NCT05215860

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

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Medicine and Radiology, CDER, AIIMS

New Delhi, National Capital Territory of Delhi, 100029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any oral lesion suspicious of malignancy.

Treatment and study plan

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

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

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

Primary outcomes

  1. Habit quit rates

    Time frame: 6 months

    Discontinuation of habit more than 1 month.

Secondary outcomes

  1. Size of oral lesions

    Time frame: 6 months

    Change in size of lesions from baseline in millimeters

  2. Oral burning sensation

    Time frame: 6 months

    Change in oral burning sensation from baseline Visual Analogue Scale (VAS) scale 0-10; 0: No oral burning sensation; 10: Worst oral burning sensation

  3. Colour of oral lesions

    Time frame: 6 months

    Change in colour of oral lesions from red to white

  4. Inter incisal mouth opening

    Time frame: 6 months

    Change in interincisal mouth opening from baseline in millimeters

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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