Clinical trial NCT06498180: Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus
Official title: A Randomized Self-control Study of Periodontal Initial Treatment Under Local Anesthesia Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Lichen Planus
Periodontal Diseases
Keywords: Periodontal initial therapy
Erosive oral lichen planus
Local anesthesia
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The erosion area of oral lichen planus
timeFrame: 3 months
Secondary outcomes:
measure: visual analogue scale
timeFrame: 2, 4, 8, and 12 weeks
measure: Clinical score of oral lichen planus
timeFrame: 2, 4, 8, and 12 weeks
measure: probing depth
timeFrame: 4, 8, and 12 weeks
measure: clinical attachment loss
timeFrame: 4, 8, and 12 weeks
measure: plaque index
timeFrame: 4, 8, and 12 weeks
measure: Full mouth bleeding scores
timeFrame: 4, 8, and 12 weeks
Other outcomes:
measure: complication
timeFrame: 2, 4, 8, and 12 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Linjun Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: