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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin Group | Experimental | Curcumin nanogels applied 3 times daily for 4 weeks |
|
| Fluocinolone Paste Group | Active Comparator | 0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin in Nanogels | Drug | Participants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in OLP-DAS Score | 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:
The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity. | Baseline, 2 weeks, and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Product Satisfaction Questionnaire | Product satisfaction will be evaluated using a modified 6-item Product Satisfaction Questionnaire. Items include:
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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tossapol Maneethorn, D.D.S. | Contact | 086-9253975 | comeblack_ubama@hotmail.com | |
| Pirawish Limlawan, D.D.S., Ph.D. | Contact | 084-090-3309 | pirawish@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pirawish Limlawan, D.D.S., Ph.D. | Faculty of Dentistry, Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Chulalongkorn University | Recruiting | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D000080385 | Nanogels |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| 0.1% Fluocinolone Acetonide Oral Paste | Drug | 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. |
|
| At 4 weeks after treatment start |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D005782 | Gels |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D053761 | Nanocomposites |
| D049329 | Nanostructures |
| D053758 | Nanoparticles |