Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
Primary Purpose
Precancerous Conditions
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders
visual exposure to personal intraoral photographs of oral lesions at baseline and review
Sponsored by
About this trial
This is an interventional prevention trial for Precancerous Conditions focused on measuring cessation, tobacco use, smokeless tobacco, areca, intraoral photography, abstinence
Eligibility Criteria
Inclusion Criteria:
- Current tobacco and areca nut users.
- Presence of oral potentially malignant disorders
Exclusion Criteria:
• Any oral lesion suspicious of malignancy.
Sites / Locations
- Oral Medicine and Radiology, CDER, AIIMS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Habit cessation counselling with management for OPMD
Habit cessation counselling, management for OPMD and intraoral photographs
Arm Description
n=100; Habit cessation counselling with general and medical management for OPMD
n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review
Outcomes
Primary Outcome Measures
Habit quit rates
Discontinuation of habit more than 1 month.
Secondary Outcome Measures
Size of oral lesions
Change in size of lesions from baseline in millimeters
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
Colour of oral lesions
Change in colour of oral lesions from red to white
Inter incisal mouth opening
Change in interincisal mouth opening from baseline in millimeters
Full Information
NCT ID
NCT05215860
First Posted
December 25, 2021
Last Updated
January 28, 2022
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT05215860
Brief Title
Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Conditions
Keywords
cessation, tobacco use, smokeless tobacco, areca, intraoral photography, abstinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective pilot interventional longitudinal study
Masking
Investigator
Masking Description
The investigator who provided behavioural counselling to the participants was blinded to their clinical diagnosis of oral lesions
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Habit cessation counselling with management for OPMD
Arm Type
Active Comparator
Arm Description
n=100; Habit cessation counselling with general and medical management for OPMD
Arm Title
Habit cessation counselling, management for OPMD and intraoral photographs
Arm Type
Experimental
Arm Description
n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review
Intervention Type
Behavioral
Intervention Name(s)
Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders
Intervention Description
WHO toolkit for Tobacco cessation (5A's and 5R's model)
Intervention Type
Other
Intervention Name(s)
visual exposure to personal intraoral photographs of oral lesions at baseline and review
Intervention Description
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 Outcome Measure Information:
Title
Habit quit rates
Description
Discontinuation of habit more than 1 month.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Size of oral lesions
Description
Change in size of lesions from baseline in millimeters
Time Frame
6 months
Title
Oral burning sensation
Description
Change in oral burning sensation from baseline Visual Analogue Scale (VAS) scale 0-10; 0: No oral burning sensation; 10: Worst oral burning sensation
Time Frame
6 months
Title
Colour of oral lesions
Description
Change in colour of oral lesions from red to white
Time Frame
6 months
Title
Inter incisal mouth opening
Description
Change in interincisal mouth opening from baseline in millimeters
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current tobacco and areca nut users.
Presence of oral potentially malignant disorders
Exclusion Criteria:
• Any oral lesion suspicious of malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Gupta, MDS,FDSRCS
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral Medicine and Radiology, CDER, AIIMS
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
100029
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
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