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

NCT05215860 | Completed

• 1 other identifier: IEC-616
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Precancerous Conditions

Keywords

cessation; tobacco use; smokeless tobacco; areca; intraoral photography; abstinence

Outcome Measures

Primary Outcomes (1)

• Habit quit rates

  Discontinuation of habit more than 1 month.

  6 months

Secondary Outcomes (4)

• Size of oral lesions

  6 months

• Oral burning sensation

  6 months

• Colour of oral lesions

  6 months

• Inter incisal mouth opening

  6 months

Study Arms (2)

Habit cessation counselling with management for OPMD

ACTIVE COMPARATOR

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

Habit cessation counselling, management for OPMD and intraoral photographs

EXPERIMENTAL

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

Interventions

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)

Habit cessation counselling with management for OPMD; Habit cessation counselling, management for OPMD and intraoral photographs

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

Habit cessation counselling, management for OPMD and intraoral photographs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any oral lesion suspicious of malignancy.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Oral Medicine and Radiology, CDER, AIIMS

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

Location

MeSH Terms

Conditions

Precancerous Conditions; Tobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Neoplasms; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shalini Gupta, MDS,FDSRCS

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who provided behavioural counselling to the participants was blinded to their clinical diagnosis of oral lesions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: A prospective pilot interventional longitudinal study

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 31, 2022
• Study Start: September 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after publication in journal for a period of 12 months
• Access Criteria: email of principal investigator shalinigupta@hotmail.com

Locations

IN (1)