Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-30 @ 1:48 AM
Study NCT ID:
NCT04368650
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization involved the computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinding was ensured by assigning the block of sites to study groups according to the specified sequence by a second operator who coded the two treatment sites selected from every patient by the first operator into the following groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone fill', 'timeFrame': '6 months', 'description': 'bone fill evaluation done after 6 months by using ImageJ® software'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sticky bone', 'Intrabony defects', 'Regeneration'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study evaluated the regenerative potential of rhBMP-2 gel in intrabony defects when compared to sticky bone (control).', 'detailedDescription': 'It was done in 40 subjects who were evaluated for a period of 6 months. the results were evaluated clinically (CAL, PPD) and radiographically (bone fill) and after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy male and female patients age 20-55 years with intrabony defects and probing pocket depth of ≥5mm after initial therapy were included in the study.\n\nExclusion Criteria:\n\n* Medically compromised patients, Subjects who underwent radiotherapy or chemotherapy and smokers were excluded.'}, 'identificationModule': {'nctId': 'NCT04368650', 'briefTitle': 'RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'SVS Institute of Dental Sciences'}, 'officialTitle': 'Evaluation of Rhbmp-2 And Sticky Bone in Intrabony Defects - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SVSIDS/PERIO/4/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main treatment group', 'description': 'The in situ BMP-2 gel was prepared to a concentration of approximately 0.5 μg/ml and were stored at 4oC. The gel was then dispensed at site of interest in the study.', 'interventionNames': ['Drug: BMP-2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In patients selected for control group, after degranulation, sticky bone was used to fill the defect. The surgical site was protected and covered using a periodontal dressing.', 'interventionNames': ['Procedure: PRF']}], 'interventions': [{'name': 'BMP-2', 'type': 'DRUG', 'otherNames': ['Experimental group'], 'description': 'lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.', 'armGroupLabels': ['Main treatment group']}, {'name': 'PRF', 'type': 'PROCEDURE', 'otherNames': ['Sticky bone group'], 'description': "For the preparation of sticky bone, the patient's venous blood is collected and centrifuged at 2400rpm for 2min which leads to two different layers in the vacutainer the upper autologous fibrin glue (AFG) and the lower RBC portion, the upper AFG is mixed with a particulate bone graft (hydroxyapatite). Within 5-10 min fibrin meshwork was formed", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '509002', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'SVS Institute of Dental Sciences, Mahabubnagar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SVS Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Dr R Viswa Chandra', 'investigatorAffiliation': 'SVS Institute of Dental Sciences'}}}}