Management of oral lichen planus with triamcinolone acetonide and injectable platelet-rich fibrin
| ISRCTN | ISRCTN11783938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11783938 |
| Secondary identifying numbers | MS3030 |
- Submission date
- 18/06/2021
- Registration date
- 09/07/2021
- Last edited
- 09/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Oral lichen planus is an inflammatory condition that affects the mucous membranes inside the mouth. This study aims to compare injectable platelet-rich fibrin and triamcinolone acetonide injections for the treatment of oral lichen planus.
Who can participate?
Patients over 18 years old with bilateral oral lichen planus
What does the study involve?
Participants are randomised by coin toss to decide which side of their mouth is to be treated with injectable platelet-rich fibrin and which is to be treated with triamcinolone acetonide. After local anaesthesia, the treatment is injected in several sites in the mouth once a week for 4 weeks. During the treatment, participants are assessed at weeks 0, 1, 2, 3, 4 and then once a month for 3 months.
What are the possible benefits and risks of participating?
The results of the study may lead to an effective and efficient treatment for oral lichen planus with few or no side effects.
When is the study starting and how long is it expected to run for?
April 2019 to October 2021
Where is the study run from?
Damascus University (Syria)
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Noor Abdualrahman Alhallak
nooralhallak93@gmail.com
Contact information
Scientific
Mazzeh
Damascus
0096311
Syria
| Phone | +963 (0)934459512 |
|---|---|
| noor7.alhallak@damascusuniversity.edu.sy |
Study information
| Study design | Split-mouth randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN11783938_PIS.pdf |
| Scientific title | Management of oral lichen planus lesions using intralesional platelet-rich fibrin and triamcinolone acetonide injection |
| Study objectives | The researchers are trying to test the efficacy of injectable platelet-rich fibrin and comparing it to triamcinolone acetonide injection in the treatment of oral lichen planus. |
| Ethics approval(s) | Approved 26/08/2019, Damascus University Rector (Baramkeh, Damascus, Syria; +966 (0)55 506 3806; email: not available), ref: MS3030 |
| Health condition(s) or problem(s) studied | Bilateral oral lichen planus lesions |
| Intervention | This study is a split-mouth randomised clinical trial. Participants are randomised by coin toss to decide which side of their mouth is to be treated by injectable platelet-rich fibrin and which is to be treated by triamcinolone acetonide (40 mg/ml). After local anesthesia, the injection is placed in several sites directly into the subepithelial connective tissue just underlying the lesion adjacent to normal mucosa, once a week for 4 weeks. During the treatment, participants are assessed at weeks 0, 1, 2, 3, 4 and then once a month for 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Injectable platelet-rich fibrin, triamcinolone acetonide |
| Primary outcome measure | Pain measured using a Visual Analog Scale (VAS) once a week during treatment for 4 weeks |
| Secondary outcome measures | 1. Clinical presentation of oral lichen planus measured using the REU scoring system at 1, 2, 3 and 4 weeks 2. Treatment response: surface areas of erythema and ulceration measured with a sterile flexible periodontal scale probe at 1, 2, 3 and 4 weeks 3. Recurrence rate measured by clinical examination at the end of treatment (day 30) 4. Quality of life measured using OHIP- 14 before treatment and at the end of treatment (day 30) |
| Overall study start date | 23/04/2019 |
| Completion date | 01/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | Patients diagnosed with oral lichen planus lesions |
| Key exclusion criteria | 1. Patients with systemic disease 2. A history of topical therapy for oral lichen planus in the last 2 weeks or systemic treatment for oral lichen planus in the last 3 months 3. Pregnancy or lactation 4. Patients who had taken immunodepressant drugs the past 3 months |
| Date of first enrolment | 15/09/2019 |
| Date of final enrolment | 01/07/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
0096311
Syria
Sponsor information
University/education
Damascus University Rector
Baramkeh
Damascus
0096311
Syria
| Phone | +963 (0)1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | After finishing the follow-up procedure and writing the article, the researchers are planning to publish (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Noor Abdualrahman Alhallak (nooralhallak93@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/07/2021 | No | Yes | ||
| Protocol file | 09/07/2021 | No | No |
Additional files
- ISRCTN11783938_PIS.pdf
- Uploaded 09/07/2021
- ISRCTN11783938_PROTOCOL.pdf
- Uploaded 09/07/2021
Editorial Notes
08/07/2021: Uploaded protocol (not peer reviewed). The participant information sheet has been uploaded.
06/07/2021: Trial's existence confirmed by Damascus University.
