Precancerous Conditions Clinical Trial
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
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 |
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).
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. |
Country | Name | City | State |
---|---|---|---|
India | Oral Medicine and Radiology, CDER, AIIMS | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
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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