Clinical Trials Logo

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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05215860
Study type Interventional
Source All India Institute of Medical Sciences, New Delhi
Contact
Status Completed
Phase N/A
Start date September 1, 2020
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04153266 - Oral Epithelial Dysplasia Informational Needs Questionnaire
Completed NCT01752101 - Identification of a Plasma Proteomic Signature for Lung Cancer N/A
Completed NCT01752114 - Early Diagnosis of Pulmonary Nodules N/A
Completed NCT00314262 - Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor Phase 1/Phase 2
Completed NCT00179361 - Natural History of Oro-pharyngeal Cancer Precursors N/A
Completed NCT00036283 - Chemoprevention of Oral Premalignant Lesions Phase 2
Recruiting NCT06165614 - Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya Phase 1
Not yet recruiting NCT01837693 - Cervical Cancer Prevention: From DNA to mRNA? - New Technologies for Cervical Cancer Screening 2 N/A
Completed NCT00043615 - Collection of Blood, Bone Marrow, Tumor or Tissue Samples N/A
Active, not recruiting NCT02158858 - A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis Phase 1/Phase 2
Completed NCT02323672 - Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions N/A
Completed NCT00851305 - Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy N/A
Not yet recruiting NCT04065737 - Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization Phase 2
Active, not recruiting NCT00655421 - Oral Cancer Screening in Mumbai, India by Primary Health Care Workers Phase 3
Completed NCT00213603 - Follow-up Modalities of Low Grade Precancerous Bronchial Lesions N/A
Completed NCT03100045 - Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3) Phase 1