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RecruitingNot ApplicableNCT06932848

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% Fluocinolone Acetonide Oral Paste in the Management of Atrophic-Erosive Oral Lichen Planus

Sponsor

Chulalongkorn University

Enrollment

30 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Oral Lichen Planus

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria13

  • 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

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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.

Locations(1)

Faculty of Dentistry, Chulalongkorn University

Bangkok, Thailand

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