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

Официальное название

A Randomized Self-control Study of Periodontal Initial Treatment Under Local Anesthesia Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus

Обзор

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

Вмешательства

• Другое 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
• Препарат 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)
• Поведенческое oral hygiene instruction
  Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes

Первичные конечные точки

• The erosion area of oral lichen planus [Срок оценки: 3 months]

Вторичные конечные точки (6)

• visual analogue scale [Срок оценки: 2, 4, 8, and 12 weeks]
• Clinical score of oral lichen planus [Срок оценки: 2, 4, 8, and 12 weeks]
• probing depth [Срок оценки: 4, 8, and 12 weeks]
• clinical attachment loss [Срок оценки: 4, 8, and 12 weeks]
• plaque index [Срок оценки: 4, 8, and 12 weeks]
• Full mouth bleeding scores [Срок оценки: 4, 8, and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Ninth People's Hospital — Шанхай

Публикации

• Chen H, Shi L, Shang Q, Wei Z, Yang Q, He Y, Li C, Zhou Z, Tang G, Sun H, Awuti G, Song Z, Shi L. Efficacy and safety of periodontal initial therapy combined with intralesional betamethasone sodium phosphate injection under local anesthesia in managing erosive oral lichen planus: study protocol for a multi-center, split-mouth, randomized self-controlled trial. Trials. 2025 Dec 22;26(1):589. doi: 1 PMID 41430296

Идентификаторы

NCT: NCT06498180 · 2024-T69-OLP-CP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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