Oral Lichen Planus, Periodontal Diseases
Conditions
Keywords
Periodontal initial therapy, Erosive oral lichen planus, Local anesthesia
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
Interventions
OTHERPeriodontal 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
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)
BEHAVIORALoral hygiene instruction
Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The erosion area of oral lichen planus | 3 months | The erosion area of oral lichen planus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale | 2, 4, 8, and 12 weeks | 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 |
| Clinical score of oral lichen planus | 2, 4, 8, and 12 weeks | — |
| probing depth | 4, 8, and 12 weeks | — |
| plaque index | 4, 8, and 12 weeks | — |
| Full mouth bleeding scores | 4, 8, and 12 weeks | — |
| clinical attachment loss | 4, 8, and 12 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| complication | 2, 4, 8, and 12 weeks | Infection, bleeding, liver and kidney damage, difficulty eating due to pain |
Countries
China
Contacts
Primary ContactHong Zhen, Doctor
Outcome results
None listed