To see effect of 3 different treatment modalities for white patch in oral cavity

Pre and post treatment expression of p53, iNOS and TGF-beta in Potentially malignant oral disorders

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007571

Enrollment

Registered

2016-12-14

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: null- Oral Leukoplakia

Interventions

Intervention1: Oral Vitamin A capsules: 3,00,000 IU weekly for 9 months Intervention2: Topical Bleomycin: 1% wt/vol bleomycin in DMSO was applied to involved area for 5 minutes once daily for 14 conse

Eligibility

Inclusion criteria

Inclusion criteria: Patients with white lesion or mixed red and white lesion of oral mucosa clinically diagnosed as leukoplakia based on criteria from World Health Organization

Exclusion criteria

Exclusion criteria: 1. Any white patch caused by friction 2. Patients with severe systemic disease including pregnant women, respiratory, cardiovascular, renal & hepatic disease 3. Those not willing to Participate

Design outcomes

Primary

Measure	Time frame
Response was graded based on size of lesion as: 1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) 2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) 3. Stable response: no response or no change in size of lesion 4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion. Timepoint: Response was graded based on size of lesion as: 1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) 2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) 3. Stable response: no response or no change in size of lesion 4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion.	—

Measure

Time frame

Response was graded based on size of lesion as: 1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) 2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) 3. Stable response: no response or no change in size of lesion 4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion. Timepoint: Response was graded based on size of lesion as: 1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) 2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) 3. Stable response: no response or no change in size of lesion 4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion.

—

Secondary

Measure	Time frame
To report any malignant transformation or conversion to malignancy at any time during 9 months follow upTimepoint: Regular follow up was done at interval of 4 weeks upto 9 months. Any suspicious lesion was biopsied at interim stage.	—

Countries

India

Contacts

Public ContactDr Shikha

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com

Outcome results

None listed

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