Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-28 @ 6:23 PM
Study NCT ID:
NCT03769402
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-12-14', 'unreleaseDate': '2018-12-19'}, {'resetDate': '2019-01-09', 'releaseDate': '2018-12-19'}], 'estimatedResultsFirstSubmitDate': '2018-12-14'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D019343', 'term': 'Citric Acid'}], 'ancestors': [{'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Morphogenic protein 2', 'timeFrame': '1 day', 'description': 'The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)'}, {'measure': 'Bone Morphogenic protein 2', 'timeFrame': '3 days', 'description': 'The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)'}, {'measure': 'Bone Morphogenic protein 2', 'timeFrame': '7 days', 'description': 'The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)'}, {'measure': 'Bone Morphogenic protein 2', 'timeFrame': '14 days', 'description': 'The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)'}, {'measure': 'Bone Morphogenic protein 2', 'timeFrame': '30 days', 'description': 'The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)'}], 'secondaryOutcomes': [{'measure': 'Gingival Index', 'timeFrame': '6 months', 'description': 'Estimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)'}, {'measure': 'Plaque index', 'timeFrame': '6 months', 'description': 'Estimation of the amount of dental plaque according to Silness \\& Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)'}, {'measure': 'Probing depth', 'timeFrame': '6 months', 'description': 'Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe'}, {'measure': 'Radiographic bone fill', 'timeFrame': '6 months', 'description': 'Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrabony Periodontal Defect']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after surgery and clinical and radiographic parameters were reassessed after 6 months', 'detailedDescription': 'Citric acid have been widely used to treat root surfaces of periodontally affected teeth in order to render it biologically suitable for fibroblast reattachment. however, systematic reviews showed no clinical significance when it was used as a root surface conditioner. Recently it was found in experimental studies that when citric acid was used on bone surface for a brief period, it increased bone formation and improved consolidation of grafted bone to bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50% concentration for 30 seconds before washing it off and then application of bovine derived xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and radiographic parameters were taken after 6 months of follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders aged between 32-60 years.\n* Selected patient with a single site of:\n\n 1. Two walled or three walled infra-bony defect.\n 2. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.\n 3. Pocket depth of more than or equal to 5 mm.\n 4. Clinical attachment loss equal or more than 3mm\n* Patients ready to comply with oral hygiene measures.\n\nExclusion Criteria:\n\n* Any systemic disease that contra-indicates periodontal surgery or may affect healing.\n* Smokers\n* Pregnant females\n* Drug abusers'}, 'identificationModule': {'nctId': 'NCT03769402', 'briefTitle': 'The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Influence of Citric Acid Bone Surface Etching and Bone Substitute Intra-osseous Defect Fill on Crevicular Fluid BMP-2 Release Profile (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '52-376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Citric acid', 'description': 'Citric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft', 'interventionNames': ['Drug: Citric acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control test', 'interventionNames': ['Drug: Control Test']}], 'interventions': [{'name': 'Citric acid', 'type': 'DRUG', 'description': 'Citric acid ph1, 50% concentration solution', 'armGroupLabels': ['Citric acid']}, {'name': 'Control Test', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Control group, xenograft was used to fill infrabony defects without treating bone surface', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Moustafa Mukhtar', 'investigatorAffiliation': 'Ain Shams University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-12-14', 'type': 'RELEASE'}, {'date': '2018-12-19', 'type': 'UNRELEASE'}, {'date': '2018-12-19', 'type': 'RELEASE'}, {'date': '2019-01-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Moustafa Mukhtar, Teaching assistant, Ain Shams University'}}}}