Actively Recruiting
The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% Fluocinolone Acetonide Oral Paste in the Management of Atrophic-Erosive Oral Lichen Planus
Led by Chulalongkorn University · Updated on 2026-03-06
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oral lichen planus (OLP), a chronic inflammatory condition that causes painful mouth sores and affects quality of life. This clinical trial compares the effects of curcumin delivered in nanogels, a natural anti-inflammatory treatment with improved absorption, to the standard corticosteroid treatment using 0.1% fluocinolone acetonide oral paste. The goal is to see if curcumin nanogels can provide similar relief with fewer side effects. Participants will be randomly assigned to one of two groups: one applying curcumin nanogels three times daily for four weeks, and the other applying 0.1% fluocinolone acetonide oral paste on the same schedule. Both treatments target affected areas in the mouth. This double-blind trial ensures neither participants nor researchers know which treatment is given to maintain unbiased results. During the study, researchers will assess changes in the severity of oral lichen planus lesions using the Oral Lichen Planus Disease Activity Scale (OLP-DAS) at the start, two weeks, and four weeks. Participants will also complete a satisfaction questionnaire after four weeks of treatment. The total participation lasts four weeks, focusing on treatment effects and patient experience under monitored conditions.
CONDITIONS
Brief Title
The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide written informed consent
- Clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (OLP)
- Presence of symptoms (pain score greater than 0 at baseline)
- Ability to communicate and follow instructions
- Willingness to apply oral paste treatment and comply with study protocol
You will not qualify if you...
- Pregnancy or lactation
- Current orthodontic treatment
- Uncontrolled diabetes mellitus (HbA1c over 7% or fasting plasma glucose over 130 mg/dL)
- Use of anticoagulants or antiplatelet agents
- Severe dry mouth (Challacombe score over 7)
- History of gastric ulcers, duodenal ulcers, or gallstones
- Presence of any active malignancy or infection
- Use of topical or systemic treatment for OLP in the past 2 weeks
- Current use of immunosuppressants
- Known allergy to corticosteroids or herbal agents such as turmeric
- Diagnosis of oral lichenoid contact lesion or graft-versus-host disease (GVHD)
- History of allogeneic bone marrow transplantation
- Current smokers
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants apply either curcumin nanogels or 0.1% fluocinolone acetonide oral paste to affected oral areas three times daily.
Baseline visit and visits at 2 weeks and 4 weeks
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Chulalongkorn University
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
T
Tossapol Maneethorn, D.D.S.
P
Pirawish Limlawan, D.D.S., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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