Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 6:19 AM
Study NCT ID:
NCT03265093
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Injectable Platelet Rich Fibrin in Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigator, Outcomes Assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Blinded, Parallel group, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Thongprasom sign scoring system', 'timeFrame': '6 months', 'description': 'The lesions were evaluated according to Thongprasom sign scoring system'}, {'measure': 'Oral Health- Related Quality of Life index (OHIP-14)', 'timeFrame': '6 months', 'description': 'Patients were asked to grade the Oral Health- Related Quality of Life index'}], 'secondaryOutcomes': [{'measure': 'Oral Hygiene Index', 'timeFrame': '6 months', 'description': 'Oral Hygiene Index were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain Measurement', 'Platelet Activation', 'Quality of Life'], 'conditions': ['Lichen Planus']}, 'descriptionModule': {'briefSummary': '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.\n\nLichen 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\n\n-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.\n\nThe 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.\n\nThe 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', 'detailedDescription': 'Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Oral erosive lesions were diagnosed according to Andreasen classification.\n2. Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.\n3. No previous treatment of oral lichen planus at least 3 months.\n4. Willingness and ability to complete the present clinical trial.\n5. Patients of ages above 18 years old without skin involvement.\n\nExclusion Criteria:\n\n1. Histological signs of dysplasia.\n2. Using drugs associated with lichenoid reaction.\n3. Pregnant, lactating and smoker patients.\n4. Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history."}, 'identificationModule': {'nctId': 'NCT03265093', 'briefTitle': 'Use of Injectable Platelet Rich Fibrin in Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)', 'orgStudyIdInfo': {'id': 'EbSAGLAM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'experimental; Corticosteroid', 'description': 'Intralesional corticosteroid administration', 'interventionNames': ['Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental; Injectable Platelet rich fibrin', 'description': 'Injectable Platelet rich fibrin', 'interventionNames': ['Other: Platelet Rich Fibrin Injection']}], 'interventions': [{'name': 'Platelet Rich Fibrin Injection', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental; Injectable Platelet rich fibrin']}, {'name': 'Corticosteroid', 'type': 'DRUG', 'description': 'Corticosteroid injection', 'armGroupLabels': ['experimental; Corticosteroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Ebru SAĞLAM', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ebru Sağlam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Mustafa Tunalı, Assoc. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem VakifUniversity'}, {'name': 'Tuğba Ünver, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Zeliha Betül Özsağır', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}