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Evaluation and follow-up of potentially oral precancerous lesions using mobile health technology and light-based tool

Evaluation of Autofluorescence Image guided Surveillance of Oral Potentially Malignant Disorders and development of prediction model for Risk assessment in malignant Transformation: A longitudinal observational study. - SORT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032536
Enrollment
150
Registered
2021-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: K135- Oral submucous fibrosis

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Praveen BN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria- 1. All individuals aged above 18 years fulfilling at least one of the criteria- a. Having history of risk habits (Smoking/ chewing tobacco, betel leaf/nut, alcohol) b. Individuals with positive clinical signs (red or white patches, nonhealing ulcers of the mouth that last more than 3 weeks, restriction of mouth opening, and swelling of the neck) c.Individuals with high Blood pressure/ Hypertension and high blood sugar level/ Diabetes 2.All individuals aged above 40 years irrespective of habits/or oral lesions

Exclusion criteria

Exclusion criteria: 1. Currently undergoing treatment for malignancy 2. Pregnancy 3. Under treatment for tuberculosis or suffering from any acute illness

Design outcomes

Primary

MeasureTime frame
1.The malignant transformation rate amongst the study population 2.Develop prediction model for risk assessment in progression of OPMDs 3.Usefulness of objective assessment of Autofluorescence Imaging in surveillance of OPMDs. Timepoint: 1.malignant transformation will be assessed at 12 months 2.Prediction model will be developed at 3 years 3. Surveillance of OPMDs- at every 3 months—

Secondary

MeasureTime frame
1.The association of diabetes/hypertension and progression of OPMDS 2.The agreement between FHPs, Onsite and Remote diagnosis of oral lesions 3.The agreement between remote diagnosis of oral lesions by specialists and biopsy. Biopsy in field is a challenge and compliance for biopsy expected would be low 4.Prevalence of risk habits, OPMDs/ oral cancer in the study population. Timepoint: 3 years—

Countries

India

Contacts

Public ContactDr Keerthi G

KLE Societys institute of Dental Sciences

praveen.birur@gmail.com09845136960

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026