Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02594605
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2015-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applied The Platelet Rich Fibrin in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly', 'timeFrame': '4 weeks', 'description': 'Change from baseline IGF-1, VEGF, BMP-2, FGF-2 levels of GCF at 1 month were measured by periopaper.'}], 'secondaryOutcomes': [{'measure': 'Alteration of Clinical Attachment Level', 'timeFrame': '6 month', 'description': 'Change from baseline Clinical Attachment Levels at 6 months were measured with periodontal probe.'}, {'measure': 'Alteration of Periodontal Pocket Depth', 'timeFrame': '6 month', 'description': 'Change from baseline Pocket Depth at 6 months were measured with periodontal probe.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '19878476', 'type': 'BACKGROUND', 'citation': 'Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.'}, {'pmid': '30624092', 'type': 'DERIVED', 'citation': 'Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.', 'detailedDescription': 'PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy\n\nExclusion Criteria:\n\n* The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months'}, 'identificationModule': {'nctId': 'NCT02594605', 'briefTitle': 'Applied The Platelet Rich Fibrin in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing', 'orgStudyIdInfo': {'id': '385/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet Rich Fibrin', 'description': 'Platelet Rich Fibrin was applied with conventional flap surgery for treatment of periodontal bone loss in test group.', 'interventionNames': ['Device: Platelet Rich Fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Flap Surgery', 'description': 'Platelet Rich Fibrin was not applied to control groups. Only conventional flap surgery was applied to control groups.', 'interventionNames': ['Device: Conventional Flap Surgery']}], 'interventions': [{'name': 'Platelet Rich Fibrin', 'type': 'DEVICE', 'description': 'Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.', 'armGroupLabels': ['Platelet Rich Fibrin']}, {'name': 'Conventional Flap Surgery', 'type': 'DEVICE', 'description': 'Only Conventional Flap Surgery treatment the bone loss limitedly.', 'armGroupLabels': ['Conventional Flap Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Denizli', 'state': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Alper KIZILDAĞ', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Yasin ÇiÇEK', 'role': 'STUDY_CHAIR', 'affiliation': 'Adiyaman University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Health Sciences Institute', 'investigatorFullName': 'Alper KIZILDAĞ', 'investigatorAffiliation': 'Ataturk University'}}}}