Effect of Vitamin A and Beta-Carotene on Recurrence After Surgical Treatment of Oral Leukoplakia: A Prospective Study

ASSESSING THE IMPACT OF VITAMIN A AND BETA-CAROTENE ON RECURRENCE RATES FOLLOWING SURGICAL TREATMENT OF ORAL LEUKOPLAKIA : A PROSPECTIVE STUDY - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108696

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: -

Interventions

Intervention1: surgical excision of leukoplakia: surgical excision of leukoplakia followed by chemopreventive methods Vitamin A 50,000IU /40 gm beta carotene Control Intervention1: comparethe chemopre

Eligibility

Inclusion criteria

Inclusion criteria: Discrete lesions less than 3cm in size on buccal mucosa. Histopathologically low medium and high risk epithelial dysplasia.

Exclusion criteria

Exclusion criteria: Lesion size more than3cm in size. Any other systemic pathologies. Hb less than 10 gm/dL Any previous treatment done for oral leukoplakia. Previous or current diagnosis of squamous cell carcinoma. other etiological factors sharp cusp in dentition, fractured tooth, lip biting habits etc.

Design outcomes

Primary

Measure	Time frame
Recurrence of oral leukoplakia at the surgical site or adjacent mucosa, assessed clinically at 3, 6, and 9 months following surgical excision, with or without adjunctive Vitamin A or beta-carotene therapy.Timepoint: At 1month following surgical excision.	—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDrAjay Parihar

GOVERNMENT COLLEGE OF DENTISTRY,INDORE

ajaycbct@gmail.com09926430661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026