Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04786327
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004492', 'term': 'Edetic Acid'}], 'ancestors': [{'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in probing pocket depth', 'timeFrame': '9 months', 'description': 'the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe'}, {'measure': 'the change bleeding on probing score', 'timeFrame': '9 months', 'description': 'the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period'}, {'measure': 'the change Clinical attachment level', 'timeFrame': '9 months', 'description': 'the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe'}, {'measure': 'Cone beam radiograph', 'timeFrame': '9 months', 'description': 'Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic periodontitis', 'Intra-bony defects', 'Minimally invasive surgical technique', 'Platelet rich fibrin,', 'Growth factor enhanced matrix 21S'], 'conditions': ['Periodontal Regeneration']}, 'descriptionModule': {'briefSummary': 'Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density', 'detailedDescription': ': Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007\n\nExclusion Criteria:\n\n* Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.\n* Smokers\n* Pregnant patients.\n* Patients with aggressive periodontitis.\n* Patients with multiple interconnected vertical defect walls.'}, 'identificationModule': {'nctId': 'NCT04786327', 'acronym': 'RCT', 'briefTitle': 'Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'treated by using Minimally invasive flap only.', 'description': '7 sites treated with Minimally invasive flap only', 'interventionNames': ['Procedure: Minimal invasive flap technique']}, {'type': 'EXPERIMENTAL', 'label': 'Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .', 'description': '7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft', 'interventionNames': ['Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin']}, {'type': 'EXPERIMENTAL', 'label': 'MIST with root conditioning (EDTA) and GEM 21S .', 'description': '7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S', 'interventionNames': ['Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S']}], 'interventions': [{'name': 'Minimal invasive flap technique', 'type': 'PROCEDURE', 'otherNames': ['regenerative surgery'], 'description': 'contained defect treated with Minimally invasive flap', 'armGroupLabels': ['treated by using Minimally invasive flap only.']}, {'name': 'Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin', 'type': 'PROCEDURE', 'otherNames': ['regenerative surgery'], 'description': 'contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft', 'armGroupLabels': ['Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .']}, {'name': 'minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['regenerative surgery'], 'description': 'contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect', 'armGroupLabels': ['MIST with root conditioning (EDTA) and GEM 21S .']}]}, 'contactsLocationsModule': {'locations': [{'zip': '020', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Malak Mohamed Shoukheba', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'malak m shoukheba, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'tanta university faculty of dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate prof', 'investigatorFullName': 'malak mohamed shoukheba', 'investigatorAffiliation': 'Tanta University'}}}}