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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal initial treatment under local anesthesia | Other | Removal of plaque retention factors, supragingival scaling and subgingival scraping under local anesthesia with articaine (combined with manual and ultrasound methods), and polishing |
| Measure | Description | Time Frame |
|---|---|---|
| The erosion area of oral lichen planus | The erosion area of oral lichen planus | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2, 4, 8, and 12 weeks |
| Clinical score of oral lichen planus |
| Measure | Description | Time Frame |
|---|---|---|
| complication | Infection, bleeding, liver and kidney damage, difficulty eating due to pain | 2, 4, 8, and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Zhen, Doctor | Contact | +86-021-53315576 | shjyiec@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Linjun Shi, Doctor | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41430296 | Derived | Chen H, Shi L, Shang Q, Wei Z, Yang Q, He Y, Li C, Zhou Z, Tang G, Sun H, Awuti G, Song Z, Shi L. Efficacy and safety of periodontal initial therapy combined with intralesional betamethasone sodium phosphate injection under local anesthesia in managing erosive oral lichen planus: study protocol for a multi-center, split-mouth, randomized self-controlled trial. Trials. 2025 Dec 22;26(1):589. doi: 10.1186/s13063-025-09340-5. |
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| 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 |
|
| 2, 4, 8, and 12 weeks |
| probing depth | 4, 8, and 12 weeks |
| clinical attachment loss | 4, 8, and 12 weeks |
| plaque index | 4, 8, and 12 weeks |
| Full mouth bleeding scores | 4, 8, and 12 weeks |
| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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