Prevalence of precancerous lesions and its associated factors in Manipur

Not yet recruiting

Conditions: INDIVIDUALS WITH SIGNS AND SYMPTOMS OF ORAL PREMALIGNANT LESIONS AND CONDITIONS

Registration Number: CTRI/2021/06/034010

Lead Sponsor: Indian Council of Medical Research

Brief Summary: A)Background Globally oral cancer is one of the most common cancers and are preceded by oral pre-malignant lesions and conditions such as oral leukoplakia, oral submucous fibrosis (OSMF),and oral erythroplakia which can be easily detected by visual inspection or palpation by health care professionals

B)NoveltyThe proposed study on Oral Premalignant Lesions and conditions would be the first of its kind in the northeast part of India.There is a high rate of mortality and morbidity among individuals and hence it requires to be detected in the premalignant stage to prevent deaths.

C)Objectives

1. To estimate the prevalence of oral premalignant lesions.

2. To identify the probable risk factors associated with oral premalignant lesions

3.To suggest preventive measures for oral cancers by early identification of oral premalignant lesions.

2. 4. To prevent malignant transformation of these cases by early detection and to counsel the detected cases for pursuing early treatment.

3. 5.To address the north eastern community for awareness and prevention of cancer through this study.

D)Methods*:*

The present study will include case and control group. Individual having history of tobacco usage, denture wearers or any other irritational factors such as malposed teeth impinging on the mucosa and/or having signs and symptoms of OPML and conditions would be included in the case group while those presenting with no signs of OPML and conditions but having the history of tobacco usage, denture wearers, or any other irritational factor, etc would constitute to control group. All individuals will be subjected to a questionnaire and the oralcavity of these participants will be examined. Individuals belonging to the case group would then be subjected to vital staining using toluidine blue dye and biopsy followed by histopathological examination. The data obtained will be subjected to statistical analysis.

E) Expected outcome*:* The present study is expected to show high prevalence of oralpremalignant lesions and hence can be used to predict the incidence of oral cancers.

F)Keywords: Oral Premalignant Lesions, Oral Premalignant Conditions, Leukoplakia, Oral Submucous Fibrosis, Tobacco use

G)Abbreviations**:** OPML= Oral Premalignant Lesions, OSMF= Oral Submucous Fibrosis

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 2800

Inclusion Criteria

1)individuals residing in Manipur for more than 6months 2)individuals who have the history of tobacco usage, denture wearers or any other irritational factors and/or having signs and symptoms of oral premalignantlesions.

Exclusion Criteria

1)Individuals less than 18yrs of age 2)Migratory population with not more than 6 months of residence in Manipur 3)Individuals not having history of tobacco usage ,denture wearers,or any other irritational factors 4)Individuals having no sings and symptoms of oral premalignant lesions.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the present study is expected to show high prevalence of oral premalignant lesions and conditions .	7 days

Secondary Outcome Measures

Name	Time	Method
the study may predict the incidence of oral cancers in Manipur	2 years

Trial Locations

Locations (1): Dental College Regional Institute of Medical Sciences (RIMS)
🇮🇳
West, MANIPUR, India
Dental College Regional Institute of Medical Sciences (RIMS)
🇮🇳West, MANIPUR, India
Dr Tanya Nandkeoliar
Principal investigator
9891725253
tanya.nandkeoliar@gmail.com