Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-28 @ 5:00 PM
Study NCT ID:
NCT04932161
Status:
UNKNOWN
Last Update Posted:
2021-06-21
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017886', 'term': 'Durapatite'}], 'ancestors': [{'id': 'D006882', 'term': 'Hydroxyapatites'}, {'id': 'D001031', 'term': 'Apatites'}, {'id': 'D002130', 'term': 'Calcium Phosphates'}, {'id': 'D010710', 'term': 'Phosphates'}, {'id': 'D010756', 'term': 'Phosphoric Acids'}, {'id': 'D017976', 'term': 'Phosphorus Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D017553', 'term': 'Phosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment Level', 'timeFrame': 'from baseline to 6 months', 'description': 'Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.'}, {'measure': 'Probing Depth', 'timeFrame': 'from baseline to 6 months', 'description': 'Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months.'}, {'measure': 'Bone Regeneration', 'timeFrame': 'at 3 months and 6 months', 'description': 'Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': 'from baseline to 6 months', 'description': 'Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.'}, {'measure': 'Gingivitis', 'timeFrame': 'from baseline to 6 months', 'description': 'Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrabony defects', 'Titanium Granules'], 'conditions': ['Intrabony Periodontal Defect']}, 'descriptionModule': {'briefSummary': 'The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).\n\nTitanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.', 'detailedDescription': 'Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.\n\nAfter reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSystemically healthy male and female patients of age \\>18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of \\>3mm.\n\nExclusion Criteria:\n\nMedically compromised patients, patients \\<18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.'}, 'identificationModule': {'nctId': 'NCT04932161', 'briefTitle': 'Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects', 'organization': {'class': 'OTHER', 'fullName': 'SVS Institute of Dental Sciences'}, 'officialTitle': 'Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study', 'orgStudyIdInfo': {'id': 'SVSIDS/PERIO/4/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Titanium Granules as a bone graft in intrabony defects', 'description': 'In test group, after reflection of flap and degranulation, bone graft i.e., titanium particles will be placed in the void created by the defect and sutures will be placed.', 'interventionNames': ['Procedure: Titanium Granules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxyapatite as a bone graft in intrabony defects', 'description': 'In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed.', 'interventionNames': ['Procedure: Hydroxyapatite']}], 'interventions': [{'name': 'Titanium Granules', 'type': 'PROCEDURE', 'description': 'After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.', 'armGroupLabels': ['Titanium Granules as a bone graft in intrabony defects']}, {'name': 'Hydroxyapatite', 'type': 'PROCEDURE', 'description': 'After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.', 'armGroupLabels': ['Hydroxyapatite as a bone graft in intrabony defects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '509002', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rampalli V Chandra, MDS; DNB', 'role': 'CONTACT', 'email': 'viswachandra@hotmail.com', 'phone': '9908183071'}], 'facility': 'SVS Institute of Dental Sciences, Mahabubnagar', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'R V Chandra, MDS;DNB;PhD', 'role': 'CONTACT', 'email': 'viswachandra@hotmail.com', 'phone': '9908183071'}]}, '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'}}}}