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

NCT ID: NCT06498180

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2028-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Periodontal initial treatment under local anesthesia

Intervention Type: OTHER

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

Intervention Type: 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)

oral hygiene instruction

Intervention Type: BEHAVIORAL

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

Glucocorticoid Therapy

Intervention Type: 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)

oral hygiene instruction

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: OTHER

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)

Intervention Type: DRUG

oral hygiene instruction

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linjun Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Hong Zhen, Doctor

Role: CONTACT

shjyiec@163.com

+86-021-53315576

Facility Contacts

Linjun Shi, Doctor

Role: primary

drshilinjun@126.com

+86 18149733306

Other Identifiers

2024-T69-OLP-CP

Identifier Type: -

Identifier Source: org_study_id