Oral Lichen Planus
Conditions
Keywords
Atrophic-Erosive Oral Lichen Planus, Curcumin, Nanogels, Fluocinolone Acetonide, Mucosal Disease, Autoimmune Disease
Brief summary
This randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lichen planus (OLP). The study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.
Detailed description
Oral lichen planus (OLP) is a chronic, immune-mediated inflammatory condition that causes painful mucosal lesions and significantly impairs patients' quality of life. Although topical corticosteroids are the standard treatment, their long-term use is associated with adverse effects. Curcumin, a natural compound with anti-inflammatory and antioxidant properties, has shown promise as an alternative treatment. However, its clinical application is limited by poor bioavailability. This randomized, double-blind, controlled clinical trial aims to compare the therapeutic effects of curcumin in nanogels and 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive OLP. Thirty eligible participants will be randomly assigned to either the curcumin nanogel or fluocinolone group, and treatment outcomes will be evaluated using the Oral Lichen Planus Disease Activity Scale (OLP-DAS) and a patient satisfaction questionnaire over a 4-week period. The study is conducted at the Faculty of Dentistry, Chulalongkorn University, and seeks to evaluate whether curcumin nanogels offer comparable therapeutic efficacy to corticosteroids, with potentially fewer side effects.
Interventions
DRUGCurcumin in Nanogels
Participants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks.
DRUG0.1% Fluocinolone Acetonide Oral Paste
Participants will apply 0.1% fluocinolone acetonide oral paste to the affected oral mucosa three times daily for 4 weeks. This corticosteroid paste is the standard treatment for oral lichen planus.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (NRS pain score \> 0 at baseline) * Ability to communicate and follow instructions * Willingness to apply oral paste treatment and comply with study protocol
Exclusion criteria
* Pregnancy or lactation * Current orthodontic treatment * Uncontrolled diabetes mellitus (HbA1c \> 7% or FPG \> 130 mg/dL) * Use of anticoagulants or antiplatelet agents * Severe dry mouth (Challacombe score \> 7) * History of gastric ulcers, duodenal ulcers, or gallstones * Presence of any active malignancy or infection * Use of topical/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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in OLP-DAS Score | Baseline, 2 weeks, and 4 weeks | Evaluation of change in Oral Lichen Planus-Disease Activity Scale (OLP-DAS) score, which includes lesion severity, lesion extent, and pain score, from baseline to follow-up The Oral Lichen Planus-Disease Activity Scale (OLP-DAS) includes 3 components: * OLP Sign Score (0-65) * OLP Severity Index (0-20) * Numerical Rating Scale for pain (0-10) The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product Satisfaction Questionnaire | At 4 weeks after treatment start | Product satisfaction will be evaluated using a modified 6-item Product Satisfaction Questionnaire. Items include: * Taste of the oral paste * Oral sensation * Irritation * Convenience of use * Willingness to continue using the product * Overall satisfaction Each item is scored from 0 (not satisfied at all) to 10 (completely satisfied). The total score ranges from 0 to 60. Higher scores indicate better satisfaction. Minimum Value: 0 Maximum Value: 60 Units of Measure: Points Meaning of Higher Scores: Better outcome (higher satisfaction) |
Countries
Thailand
Contacts
CONTACTTossapol Maneethorn, D.D.S.
CONTACTPirawish Limlawan, D.D.S., Ph.D.
PRINCIPAL_INVESTIGATORPirawish Limlawan, D.D.S., Ph.D.
Faculty of Dentistry, Chulalongkorn University
Outcome results
None listed