Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus

NCT06498180 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Phase

Not applicable

Started

2024-12-31

Last updated

2024-07-12

Condition(s) studied

Oral Lichen PlanusPeriodontal Diseases

Investigational drug(s) / intervention(s)

Periodontal initial treatment under local anesthesiaGlucocorticoid Therapyoral hygiene instruction

Periodontal initial treatment under local anesthesia: Removal of plaque retention factors, supragingival scaling and subgingival scraping under local anesthesia with articaine (combined with manual and ultrasound methods), and polishing

Glucocorticoid Therapy: Local blockade therapy with Betamethasone Sodium Phosphate Injection (containing 1.4mg Betamethasone equivalent), local use of 1% Triamcinolone Acetate Ointment, and rinsing with 1% Sodium Bicarbonate (avoiding systemic use during visits)

oral hygiene instruction: Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes

Study summary

The purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. It will also understand the safety of this treatment regimen.

This study is a single-center, parallel-group, randomized self-controlled trial. The researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus.

Participants will:

One side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy Clinical examination at 2, 4, 8, and 12 weeks after treatment Note down the size of their erosion lesion area and periodontal clinical parameters

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Existence of erosive oral lichen planus that lasts for more than 2 months * Erosive lesions are located in the buccal mucosa and gingival buccal sulcus of the bilateral mandibular posterior teeth area * The erosive lesions are mild to moderate (single or multiple small area erosions; 3mm ≤ longest diameter ≤ 10mm; 9mm2 ≤ total area of erosions ≤ 100mm2), and the degree of erosion on both sides is similar (the difference in the size of erosion on both sides does not exceed ± 25%) * The plaque index in the area of erosive lesions is ≥ 3; Dental calculus index ≥ 2; Gingival index ≥ 2; * Accompanied by stage II-IV extensive periodontitis Exclusion Criteria: * Pregnant women, lactating women, or women planning to conceive during the trial period * Patients with coagulation dysfunction or other uncontrolled systemic diseases who cannot undergo periodontal treatment * Has undergone basic periodontal treatment within the past 6 months * Individuals with a history of allergy to local anesthetic drugs such as articaine * Individuals with contraindications to glucocorticoids * Patients with lesion area erosion caused by trauma or chemical stimulation * Patients with mental disorders who are difficult to cooperate with treatment

Primary outcome measure(s)

The erosion area of oral lichen planus — 3 months
The erosion area of oral lichen planus

Trial sites (1)

Facility	City	Region	Status
Shanghai Ninth People's Hospital	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06498180 on ClinicalTrials.gov ↗ ← All trials in China