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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habit cessation counselling with management for OPMD | Active Comparator | n=100; Habit cessation counselling with general and medical management for OPMD |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Habit quit rates | Discontinuation of habit more than 1 month. | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Any oral lesion suspicious of malignancy.
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| Name | Affiliation | Role |
|---|---|---|
| Shalini Gupta, MDS,FDSRCS | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Medicine and Radiology, CDER, AIIMS | New Delhi | National Capital Territory of Delhi | 100029 | India |
The study data can be made available on request via email to principal investigator
after publication in journal for a period of 12 months
email of principal investigator shalinigupta@hotmail.com
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A prospective pilot interventional longitudinal study
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The investigator who provided behavioural counselling to the participants was blinded to their clinical diagnosis of oral lesions
| 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 |
|
| 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 |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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