CTRI/2018/08/015185.

Trial name or title	Treatment for the local application of oral ulcers seen in oral lichen planus
Methods	Parallel, multiple arm, RCT India
Participants	Adults affected by OLP Inclusion criteria: clinically determined cases of OLP; histopathologically confirmed cases of OLP; aged 20–65 years; individuals compliant and ready for study procedure and who will give written consent to undergo the study willingly. Exclusion criteria: asymptomatic; history of use of antibiotics within 1 month or immunomodulating agents within 3 months; presence of lichenoid reactions caused by amalgam fillings, drugs, etc; pregnant women and nursing mothers; uncontrolled diabetes mellitus, hypertension, acidity, immunocompromised conditions; history of allergy or hypersensitivity to drugs under trial; unwilling to undergo the study and do not give informed consent.
Interventions	Group A (intervention 1): clobetasol propionate 0.05% ointment topically using finger on all involved surfaces and to keep it there for 15 minutes followed by rinsing with cold water. Participant will be recalled and assessed every week for 1 month, then recalled every 15 days for next 2 months. Group B (intervention 2): Nano Bio Fusion gel (NBF): natural product consisting of vitamin E, vitamin C and Propolis, which has anti‐inflammatory and antioxidant properties. Topical application 3 times daily for 1 month. Recall every week for first month and then every 15 days for next 3 months. Group C (intervention 3): topical curcumin oral gel, which has anti‐inflammatory properties. Topical application 3 times daily for 1 month. Recall every week for first month and then every 15 days for next 3 months. Group D (control 1): Nano Bio Fusion gel (NBF) topically using finger on all involved surfaces and to keep it there for 15 minutes followed by rinsing with cold water. Participant will be recalled and assessed every week for 1 month, then recalled every 15 days for next 2 months. Group E (control 2): topical curcumin oral gel topically using finger on all involved surfaces and to keep it there for 15 minutes followed by rinsing with cold water. Participant will be recalled and assessed every week for 1 month, then recalled every 15 days for next 2 months.
Outcomes	Primary outcomes: burning sensation (VAS), clinical improvement of the lesion (Escudier scale) Secondary outcomes: mucosal atrophy, candidiasis, estimation of malignant transformation rate of OLP
Starting date	30 October 2017
Contact information	Dr Priyanka Verma, priyankavermamds@gmail.com
Notes	Sponsor: Maulana Azad Institute of Dental Sciences