Evidence map›Paper›PMID 41430296›Full record

ArticleTrials2025

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.

Huiwen Chen, Liran Shi, Qianhui Shang, Zihao Wei, Qiaozhen Yang, Yining He, Chenxi Li, Zengtong Zhou, Guoyao Tang, Hongying Sun and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06498180 (A Randomized Self-control Study of Periodontal Initial Treatment Under Local Anesthesia Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06498180 nanot yet recruitingnot on this map

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

TypeinterventionalSponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityRan2024 to 2028Enrolled29ConditionsOral Lichen Planus, Periodontal DiseasesArmsPeriodontal initial treatment under local anesthesia, Glucocorticoid Therapy, oral hygiene instruction
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Huiwen Chen *Department of Periodontology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China.
Liran Shi *Department of Stomatology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.
Qianhui Shang *Department of Periodontics, the First Affiliated Hospital of Xinjiang Medical University (the Affiliated Stomatology Hospital of Xinjiang Medical University), Stomatology Disease Institute of Xinjiang Uyghur Autonomous Region, Urumqi, China.
Zihao WeiSchool of Stomatology, Zhejiang Provincial Clinical Research Center for Oral Diseases, Stomatology Hospital, Zhejiang University School of Medicine, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Hangzhou, China.
Qiaozhen YangDepartment of Stomatology, Huashan Hospital, Fudan University, Shanghai, China.
Yining HeBiostatistics Office of Clinical Research Unit, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
Chenxi LiDepartment of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China.
Zengtong ZhouDepartment of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China.
Guoyao TangDepartment of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China.
Hongying SunDepartment of Stomatology, Huashan Hospital, Fudan University, Shanghai, China. sunhongying@fudan.edu.cn.
Gulinuer AwutiDepartment of Periodontics, the First Affiliated Hospital of Xinjiang Medical University (the Affiliated Stomatology Hospital of Xinjiang Medical University), Stomatology Disease Institute of Xinjiang Uyghur Autonomous Region, Urumqi, China. guawuti@sina.com.
Zhongchen SongDepartment of Periodontology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China. szhongchen@sina.com.
Linjun ShiDepartment of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, College of Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China. drshilinjun@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionErosive 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 registrationThe 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.

Indexed as

Anesthesia, LocalBetamethasoneGlucocorticoidsLichen Planus, OralPeriodontitisAdultChinaFemaleHumansInjections, IntralesionalMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeBetamethasonebetamethasone sodium phosphateGlucocorticoidsAnesthesiaBetamethasoneErosive lichen planusIntralesional injectionPeriodontal therapyPeriodontitis

Identifiers

PMID41430296
PMCPMC12751475

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.