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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Periodontal initial treatment under local anesthesia

    Other intervention

    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

    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

    Behavioral

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

Treatment groups

29 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 3 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The erosion area of oral lichen planus

The erosion area of oral lichen planus

Time frame
3 months

Secondary outcomes

1

visual analogue scale

Mark a horizontal line of 0-10cm on paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, with higher scores indicating greater pain intensity

Time frame
2, 4, 8, and 12 weeks
2

Clinical score of oral lichen planus

Time frame
2, 4, 8, and 12 weeks
3

probing depth

Time frame
4, 8, and 12 weeks
4

clinical attachment loss

Time frame
4, 8, and 12 weeks

Other outcomes

1

complication

Infection, bleeding, liver and kidney damage, difficulty eating due to pain

Time frame
2, 4, 8, and 12 weeks

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: