Use of Injectable Platelet Rich Fibrin in Lichen Planus
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|ClinicalTrials.gov Identifier: NCT03265093|
Recruitment Status : Unknown
Verified September 2017 by Bezmialem Vakif University.
Recruitment status was: Recruiting
First Posted : August 29, 2017
Last Update Posted : September 7, 2017
Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.
Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long
-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.
The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.
The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions
|Condition or disease||Intervention/treatment||Phase|
|Lichen Planus||Other: Platelet Rich Fibrin Injection Drug: Corticosteroid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Blinded, Parallel group, randomized controlled trial|
|Masking Description:||Investigator, Outcomes Assessor|
|Official Title:||Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)|
|Actual Study Start Date :||May 3, 2017|
|Estimated Primary Completion Date :||August 24, 2018|
|Estimated Study Completion Date :||December 29, 2018|
Active Comparator: experimental; Corticosteroid
Intralesional corticosteroid administration
Experimental: Experimental; Injectable Platelet rich fibrin
Injectable Platelet rich fibrin
Other: Platelet Rich Fibrin Injection
Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.
- Visual Analog Scale [ Time Frame: 3 months ]Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.
- Objective evaluation [ Time Frame: 3 months ]The lesions were evaluated according to Thongprasom sign scoring system
- Quality of life [ Time Frame: 3 months ]The oral health quality of life index (OHQoL-16) Grid in mm.
- Oral Hygiene Index [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265093
|Contact: Ebru Sağlam, PhDfirstname.lastname@example.org|
|Contact: Zeliha Betül Özsağıremail@example.com|
|İstanbul, Fatih, Turkey, 34093|
|Contact: Ebru Sağlam, PhD +905052604617 firstname.lastname@example.org|
|Contact: Zeliha Betül Özsağır +905076699794 email@example.com|
|Principal Investigator: Mustafa Tunalı, Assoc.Prof.|
|Principal Investigator: .Ebru Sağlam, PhD|
|Principal Investigator: Tuğba Ünver, PhD|
|Principal Investigator: Zeliha Betül Özsağır|
|Study Chair:||Ebru Sağlam, PhD||Bezmialem Vakif University|
|Study Director:||Mustafa Tunalı, Assoc. prof.||Bezmialem VakifUniversity|
|Principal Investigator:||Tuğba Ünver, PhD||Bezmialem Vakif University|
|Principal Investigator:||Zeliha Betül Özsağır||Bezmialem Vakif University|