Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-24 @ 7:50 PM
Study NCT ID:
NCT04032405
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gingival recession depth', 'timeFrame': 'six months', 'description': 'the distance between the CEJ and gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre'}, {'measure': 'Keratized tissue height', 'timeFrame': 'six months', 'description': 'measured from the mucogingival junction to the gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['connective tissue graft'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF.\n\nMethods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥19 years of age,\n* Periodontally and systemically healthy,\n* FMPS and FMBS \\<15%,\n* Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,\n\nExclusion Criteria:\n\nSmoking,\n\n* Contraindications for surgery,\n* Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.'}, 'identificationModule': {'nctId': 'NCT04032405', 'briefTitle': 'Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects. A Controlled Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'CukurovaU-PER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CAF+CTG', 'description': 'the combined connective tissue graft (CTG) with coronally advanced flap (CAF)', 'interventionNames': ['Procedure: CAF+CTG+i-prf']}, {'type': 'EXPERIMENTAL', 'label': 'CAF+CTG+i-prf', 'description': 'the combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)', 'interventionNames': ['Procedure: CAF+CTG+i-prf']}], 'interventions': [{'name': 'CAF+CTG+i-prf', 'type': 'PROCEDURE', 'description': 'combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)', 'armGroupLabels': ['CAF+CTG', 'CAF+CTG+i-prf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01130', 'city': 'Adana', 'state': 'Balcalı', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'onur ucak Turer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CukurovaU Prof.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mustafa Ozcan', 'investigatorAffiliation': 'Cukurova University'}}}}