Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04372420
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participant and outcome assessor are masked from the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-02', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BONE FILL', 'timeFrame': '6 MONTHS', 'description': 'The evaluation of bone fill was performed after 6 months by using ImageJ® software.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.', 'detailedDescription': '44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using ImageJ® software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to PRF. From this trial conducted over a period of 6 months, the unique properties associated with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material for Grade II furcation defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy male and female patients of age group 20-55 yrs\n* grade II furcation involvement and probing pocket depth of ≥5mm\n\nExclusion Criteria:\n\n* Medically compromised patients\n* subjects who underwent radiotherapy or chemotherapy in the past 12 months\n* patients having uncontrolled periodontal disease and\n* subjects smoking ≥10 cigarettes per day were excluded'}, 'identificationModule': {'nctId': 'NCT04372420', 'briefTitle': 'Bone Morphogenetic Protein-2 In Grade II Furcation Defects.', 'organization': {'class': 'OTHER', 'fullName': 'SVS Institute of Dental Sciences'}, 'officialTitle': 'Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SVSIDS/PERIO/3/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RhBMP-2', 'description': 'RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation', 'interventionNames': ['Drug: RhBMP-2 absorbable sponge in grade II furcation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLATELET RICH FIBRIN', 'description': 'Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions', 'interventionNames': ['Procedure: PLATELET RICH FIBRIN in grade II furcation']}], 'interventions': [{'name': 'RhBMP-2 absorbable sponge in grade II furcation', 'type': 'DRUG', 'otherNames': ['Experimental group'], 'description': 'The collagen sponge is impregnated with rhBMP-2 at a concentration of 0.5 μg/ml/1cm3 and were stored at 4°C. This rhBMP-2 impregnated collagen sponge was then dispensed at grade II furcation site', 'armGroupLabels': ['RhBMP-2']}, {'name': 'PLATELET RICH FIBRIN in grade II furcation', 'type': 'PROCEDURE', 'otherNames': ['Control group'], 'description': "For preparation of PRF, patient's venous blood is collected into 10ml glass tube or glass-coated plastic tube and centrifuged at 2700 rpm for 12min which leads to two different layers in the test tube, the upper platelet rich fibrin and the lower RBC portion. The formed PRF clot could then be removed from the glass tube and used in grade II furcation", 'armGroupLabels': ['PLATELET RICH FIBRIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '509002', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'RV Chandra', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SVS Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr R Viswa Chandra', 'investigatorAffiliation': 'SVS Institute of Dental Sciences'}}}}