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

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

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).

Study Overview

• Status: Completed
• Conditions: Precancerous Conditions
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 100029
      • Oral Medicine and Radiology, CDER, AIIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any oral lesion suspicious of malignancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Habit cessation counselling with management for OPMD; 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; WHO toolkit for Tobacco cessation (5A's and 5R's model)
Experimental: 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	Behavioral: 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); Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Principal Investigator: Shalini Gupta, MDS,FDSRCS, All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 25, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: smokeless tobacco; cessation; tobacco use; abstinence; areca; intraoral photography
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: IEC-616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study data can be made available on request via email to principal investigator
• IPD Sharing Time Frame: after publication in journal for a period of 12 months
• IPD Sharing Access Criteria: email of principal investigator shalinigupta@hotmail.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No