A study to assess the burden of ill effects of tobacco abuse and oral precancer in rural areas of Sangli district

Phase 1

Recruiting

Conditions: To survey approximately total 2500 or more patients with habit of tobacco chewing in any form in five rural areas and note the icidence and prevalence of oral premalignant conditions and lesions

Registration Number: CTRI/2017/11/010515

Lead Sponsor: Maharashtra University Of Health Sciences

Brief Summary: Oral cancer has become a global health problem and its increasing incidence and mortality rates are particularly relavant in certain parts of India.

Worldwide, oral cancer has one of the lowest survival rates that remain unalterd despite recent therapeutic advances. Early detection is widely recognized as the corner stone to reduce diagnostic delay and thus to improve survival. In many instances a significant proportion of oral squamous cell carcinomas developed from premalignant lesions and conditions such as leukoplakia, submucous fibrosis and lichen planus.

Identification of this oral premalignant lesions is very important in order to prevent malignant transformation and its related morbodity and mortality. The demographic details, sites and type of lesions, habits and its frequency of consumption, duration and type of habits including smoking and non smoking form, mixed habits and alcohol consumption can be studied in this respect and these hold much promice in creating awareness about association of these habits with oral precancer and cancer. Western Maharashtra is one of the important hub for tobacco manufacturing and studies have reported increased incidence of oral cancer in association with tobacco usage. Not many epidemiological studies have been conducted regarding oral precancer and hence our project aims to study the same in the rural areas of Sangli district and to creat awareness amongst the population about the deleterious effects of consumption of tobacco, areca nut and alcohol.

This cross sectional study will be carried out in the rural areas of Sangli district. Informed written consent will be obtained prior to beginning of the study. Demographic details, socioeconomic status, information related to consumption of tobacco, areca nut and alcohol or other habits will be recorded. Oral examination of all the patients will be conducted day light with help of the diagnostic instruments. Patient awareness education will be given regarding the habits and its deleterious effects. All records entered will be cross- checked for correctness. The entire data obtained will be entered in MS Excel and analyzed in statistical package for social sciences (SPSS)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 2500

Inclusion Criteria

Subjects with habit of chewing tobacco or areca nut, smoking tobacco, or alcohol consumption or any other habit 2) having signs of Oral premalignant lesions and conditions like leukoplakia, erythroplakia, oral submucus fibrosis and lichen planus.

Exclusion Criteria

Patients with white or red lesions other than oral premalignant lesions and conditions Patients with oral cancer Subjects not willing to participate in the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and prevalence of oral precancer lesions and conditions	Period of 4 months

Secondary Outcome Measures

Name	Time	Method
epidemiological study of oral precancer in western maharashtra	2 years

Trial Locations

Locations (1): Dept. of Oral Pathology and Microbiology , Vasantdada Patil Dental Ciollege And Hospital, Sangli
🇮🇳
Sangli, MAHARASHTRA, India
Dept. of Oral Pathology and Microbiology , Vasantdada Patil Dental Ciollege And Hospital, Sangli
🇮🇳Sangli, MAHARASHTRA, India
Dr Mrs Priya S Joshi
Principal investigator
9890712016
sangeetakov@yahoo.co.in