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

NCT06498180 | Not Yet Recruiting

• 1 other identifier: 2024-T69-OLP-CP
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Lichen Planus; Periodontal Diseases

Keywords

Periodontal initial therapy; Erosive oral lichen planus; Local anesthesia

Outcome Measures

Primary Outcomes (1)

• The erosion area of oral lichen planus

  The erosion area of oral lichen planus

  3 months

Secondary Outcomes (6)

• visual analogue scale

  2, 4, 8, and 12 weeks

• Clinical score of oral lichen planus

  2, 4, 8, and 12 weeks

• probing depth

  4, 8, and 12 weeks

• clinical attachment loss

  4, 8, and 12 weeks

• plaque index

  4, 8, and 12 weeks

Other Outcomes (1)

• complication

  2, 4, 8, and 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

In the experimental group, subjects will undergo periodontal initial treatment under local anesthesia combined with glucocorticoid local blockade therapy (such as triamcinolone acetonide injection), local use of triamcinolone acetonide ointment, and 1% sodium bicarbonate rinse (avoiding systemic use during visits) after baseline examination, while receiving the following professional oral hygiene guidance: Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes A periodontist with rich clinical experience will perform periodontal initial treatment under local anesthesia.

Other: Periodontal initial treatment under local anesthesia; Drug: Glucocorticoid Therapy; Behavioral: oral hygiene instruction

Control group

ACTIVE COMPARATOR

In the control group, participants will undergo routine glucocorticoid local blockade therapy (such as triamcinolone acetonide injection), local administration of triamcinolone acetonide ointment, and 1% sodium bicarbonate rinse (avoiding systemic medication during visits) after baseline examination, while receiving the following professional oral hygiene guidance: Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes Based on ethical considerations, all participants will receive full mouth periodontal initial treatment at the end of the trial.

Drug: Glucocorticoid Therapy; Behavioral: oral hygiene instruction

Interventions

Periodontal initial treatment under local anesthesia OTHER

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

Experimental group

Glucocorticoid Therapy DRUG

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)

Control group; Experimental group

oral hygiene instruction BEHAVIORAL

Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• 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: 10.1186/s13063-025-09340-5.

  PMID: 41430296 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linjun Shi, Doctor

  Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Zhen, Doctor

CONTACT

+86-021-53315576; shjyiec@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)