Curcumin vs retinoic acid topical application in treatment of oralpremalignant lesions

Not yet recruiting

Brief Summary: Potentially malignant lesions (PML) are oral mucosal lesions that are at

enhanced danger of malignant transformation compared to healthy mucosal

lesions.They account for 17% to 35% of all new cases of oral

cavity cancer and undergo malignant transformation between 0.7% and

2.9% annually.The most commonly described premalignant oral lesions

are leukoplakia,erythroplakia,oral lichen planus, and submucous

fibrosis.

The early detection and therapeutic management of these lesions are very

much essential to prevent malignant transformation.

Although many medicinal agents have been tried in the past,there is no gold standard which has been

established for treating these conditions.We are using topical application of curcumin and retinoic acid in the

treatment of these lesions.

Curcumin is a yellow color plant

derivative obtained from the root of

Curcuma longa (Turmeric) which

belongs to the ginger family,with

anti-inflammatory, antifibrotic,

antioxidant, and anticarcinognic

property.Retinoic acid is a metabolite of

vitamin A) which has significant role

in cell growth,differentiation and

apoptosis, anti inflammatory,and anti

oxidant property.

Recruitment & Eligibility

Inclusion Criteria

Age > 20 years Patient with cessation of habit 1 month before intervention.
Patients reporting to the department of oral and maxillofacial surgery with clinical sign and histologically proven premalignant lesions.
Patients with early stage lesion Patients willing to be a part of the study and giving consent for the same.

Exclusion Criteria

1)Patient with h/o topical therapy to oral lesion.
2)Patients with hypersensitivity to drug 3)Patients reporting to the department of oral and maxillofacial surgery with clinical sign and histologically proven premalignant lesions.
4)Pregnancy 5)Patients with advanced stage lesion 6)Patients with h/o reported adverse effects to treatment with retinoic acid and curcumin.

Primary Outcome Measures

Name	Time	Method
3)Change in size of lesion	1)Baseline \| 2)During application period- \| 15 days once- upto 1 month \| Every month once- upto 3 months \| 3)During followup- \| Every month once- upto 3 months
1)Pain- Visual analog scale	1)Baseline \| 2)During application period- \| 15 days once- upto 1 month \| Every month once- upto 3 months \| 3)During followup- \| Every month once- upto 3 months
2)Burning sensation of the lesion	1)Baseline \| 2)During application period- \| 15 days once- upto 1 month \| Every month once- upto 3 months \| 3)During followup- \| Every month once- upto 3 months

Secondary Outcome Measures

Name	Time	Method
Adverse effects	Single visit

Locations (1): Sri Rajiv Gandhi College of dental Sciences
🇮🇳
Bangalore, KARNATAKA, India
Sri Rajiv Gandhi College of dental Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Hemavati U
Principal investigator
9663906416
drhemau85@gmail.com