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Introduction <p>Erosive oral lichen planus (OLP) and periodontitis frequently coexist and may worsen each other. This study will evaluate the effectiveness and safety of combining periodontal initial therapy under local anesthesia with intralesional betamethasone sodium phosphate (BSP) injection in patients with erosive OLP, particularly in enhancing lesion healing.</p> Methods and analysis <p>This is a multicenter, randomized, split-mouth, self-controlled trial. We will recruit 29 adults from five tertiary centers in China. Eligible participants are adults (aged ≥ 18 years) diagnosed with erosive gingival OLP accompanied by generalized periodontitis (stage II–IV). Within each participant, sides will be randomly allocated to a test side (periodontal initial therapy under local anesthesia plus intralesional BSP) and a control side (intralesional BSP alone). Independent outcome assessors and statisticians will be strictly blinded to ensure objectivity of the assessments. The follow-up will last 6 months, with assessments at the 2nd, 4th, 8th, 12th, and 24th weeks. The primary outcome is the reduction in erosive lesion size at the 12th week. Secondary outcomes will include the complete healing rate, OLP clinical severity scores, visual analog score of pain, periodontal parameters, and complications.</p> Discussion <p>This protocol introduces an innovative method for managing erosive OLP accompanied by periodontitis by integrating periodontal initial therapy under local anesthesia with corticosteroid injections. It aims to offer a more effective and patient-centric multidisciplinary treatment strategy. The utilization of local anesthetics will enhance patient comfort and optimize adherence. Findings will guide clinical practice and motivate mechanistic studies.</p> Trial registration <p>The trial has been registered on the Chinese Clinical Trial Registry (No. ChiCTR2400083728; registered on April 30, 2024) and on the U.S. National Institutes of Health Clinical Trials website (No. NCT06498180; registered on July 12, 2024).</p> <p>Protocol version: 1.0</p> <p>Version date: 01 September 2025.</p>

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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

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  • 发表日期：

    2025年12月22日

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  • Huiwen Chen,
  • Liran Shi,
  • Qianhui Shang,
  • Zihao Wei,
  • Qiaozhen Yang,
  • Yining He,
  • Chenxi Li,
  • Zengtong Zhou,
  • Guoyao Tang,
  • Hongying Sun,
  • Gulinuer Awuti,
  • Zhongchen Song,
  • Linjun Shi

摘要

Introduction

Erosive oral lichen planus (OLP) and periodontitis frequently coexist and may worsen each other. This study will evaluate the effectiveness and safety of combining periodontal initial therapy under local anesthesia with intralesional betamethasone sodium phosphate (BSP) injection in patients with erosive OLP, particularly in enhancing lesion healing.

Methods and analysis

This is a multicenter, randomized, split-mouth, self-controlled trial. We will recruit 29 adults from five tertiary centers in China. Eligible participants are adults (aged ≥ 18 years) diagnosed with erosive gingival OLP accompanied by generalized periodontitis (stage II–IV). Within each participant, sides will be randomly allocated to a test side (periodontal initial therapy under local anesthesia plus intralesional BSP) and a control side (intralesional BSP alone). Independent outcome assessors and statisticians will be strictly blinded to ensure objectivity of the assessments. The follow-up will last 6 months, with assessments at the 2nd, 4th, 8th, 12th, and 24th weeks. The primary outcome is the reduction in erosive lesion size at the 12th week. Secondary outcomes will include the complete healing rate, OLP clinical severity scores, visual analog score of pain, periodontal parameters, and complications.

Discussion

This protocol introduces an innovative method for managing erosive OLP accompanied by periodontitis by integrating periodontal initial therapy under local anesthesia with corticosteroid injections. It aims to offer a more effective and patient-centric multidisciplinary treatment strategy. The utilization of local anesthetics will enhance patient comfort and optimize adherence. Findings will guide clinical practice and motivate mechanistic studies.

Trial registration

The trial has been registered on the Chinese Clinical Trial Registry (No. ChiCTR2400083728; registered on April 30, 2024) and on the U.S. National Institutes of Health Clinical Trials website (No. NCT06498180; registered on July 12, 2024).

Protocol version: 1.0

Version date: 01 September 2025.