Oral Leukoplakia Clinical Trial
Official title:
Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia: A Randomized Placebo Controlled Study
Oral leukoplakia is the most commonly occurring oral premalignant disorder. It has an overall
prevalence rate of 1-4% with highest prevalence rate of 10.54% in Asian countries. The
management of leukoplakia includes conventional as well as surgical modalities. The
conventional approaches include Beta Carotene, Lycopene, ascorbic acid, alpha tocopherol,
retinoids. But, no significant results are documented on regression rate and prevention of
recurrence of the lesions.
Melatonin chemically N-acetyl-5-methoxytryptamine is a hormone produced in the pineal gland.
It is synthesized from the amino acid, tryptophan. The basic physiological function of
melatonin is to control day night cycle and hence is commonly used in insomnia, jet lag and
some other psychological disorders.
Melatonin has a potent antioxidant effect and other actions such as modulation of cell cycle
and induction of apoptosis, inhibition of telomerase activity, inhibition of metastasis,
prevention of circadian disruption, anti-angiogenesis and stimulation of cell differentiation
To date, no treatment modality has demonstrated its clear superiority for leukoplakia. There
are many pathways by which melatonin can be used beneficially for management oral
leukoplakia.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | September 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Clinically and histologically proven cases of leukoplakia associated with tobacco. With age 18 years and above. Willing and able to participate in the study and signed informed consent. Exclusion Criteria: Patients suspicious of malignant transformation of the lesion with frank ulceration or growth. Patients consuming or have consumed drugs for treatment of leukoplakia. Patients who have red or white lesions persisting after radiotherapy treatment Patients with acquired and congenital immunodeficiency disorders like AIDS, chemotherapy, addiction to injectable opioids and any other significant medical or systemic or autoimmune conditions. Pregnancy or lactation phase. Known allergy to melatonin. |
Country | Name | City | State |
---|---|---|---|
India | Post graduate institute of dental sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the size of the lesion. | measurement of the lesion and scored according to RECIST criteria | four and a half months | |
Secondary | Degree of dysplasia | Grading of dysplasia according to Speight classification (2007). | four and a half months | |
Secondary | Expression of immunopositivity of ki67 cells in the lesion. | Percentage of a total number of Ki-67 positive cells to a total number of cells will be primarily deducted. | four and a half months |
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