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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Oral Lichen Planus; Periodontal Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06498180

2024-T69-OLP-CP

Details and patient eligibility

About

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

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: oral hygiene instruction

Drug: Glucocorticoid Therapy

Other: Periodontal initial treatment under local anesthesia

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: oral hygiene instruction

Drug: Glucocorticoid Therapy