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To check Effectivess of lycopene therapy versus cryotherpay for the treatment of oral leukoplakia

Phase 4
Conditions
Health Condition 1: null- Patient with biopsy proven cases of oral leukoplakia
Registration Number
CTRI/2016/04/006827
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

All healthy male and female between 15-60 years having oral leukoplakia (biopsy proven) reporting to department of oral and maxillofacial surgery , CDER AIIMS

2. Patients having size of primary lesion more than 1 cm.

3. Patient having history of tobacco chewing/smoking.

Exclusion Criteria

1.Patient having white lesion with negative history of tobacco use.

2.Patients with lesion of size less than 1 cm.

3.Patients with lesion associated with ulcero-proliferative growth or suspicious of squamous cell carcinoma.

4.Patients who are nursing or pregnant.

5.Patients with uncontrolled systemic disease.

6.Patient who are allergic to tomato and food products containing tomato extracts.

7.Patient not willing to quit the adverse habit.

8.Patient refuses to give consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare clinical response (reduction in size of leukoplakia patch) after lycopene therapy and cryotherapy in the <br/ ><br>management of oral leukoplakia.Timepoint: after 1 month and 3 month
Secondary Outcome Measures
NameTimeMethod
To see for the presence of any new localization/recurrence after therapyTimepoint: evaluation to be done after 3 month and 6 months
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