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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215860
Other study ID # IEC-616
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 30, 2021

Study information

Verified date January 2022
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Current tobacco and areca nut users. - Presence of oral potentially malignant disorders Exclusion Criteria: • Any oral lesion suspicious of malignancy.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Oral Medicine and Radiology, CDER, AIIMS New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Habit quit rates Discontinuation of habit more than 1 month. 6 months
Secondary Size of oral lesions Change in size of lesions from baseline in millimeters 6 months
Secondary 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
Secondary Colour of oral lesions Change in colour of oral lesions from red to white 6 months
Secondary Inter incisal mouth opening Change in interincisal mouth opening from baseline in millimeters 6 months
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