Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06043258
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bond Apatite in Horizontal Augmentation Versus Bio-Oss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C077540', 'term': 'Bio-Oss'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone width gain measurement', 'timeFrame': '12 months', 'description': 'CBCT used to assess horizontal bone measurement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Horizontal Ridge Deficiency']}, 'descriptionModule': {'briefSummary': 'Sixteen healthy patients selected from the Outpatient Clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University for the replacement of missing single maxillary anterior or premolar tooth (in the esthetic zone) by dental implant. Patients were selected according to the following criteria: 1) Patients older than 18 years. 2) Good general health, with no systemic diseases that might contraindicate receiving a dental implant. 3) Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis. 4) The tooth has been extracted from at least 3 months. 5) Insufficient horizontal bone (class III according to Len Tolstunov classification. 6) Good oral hygiene.\n\nPatients were classified into two groups:\n\nGroup (I) (study group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect.\n\nGroup (II) (positive control group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane.\n\nPatients were evaluated with the following clinical and radiological parameters presurgical and 12 months after operation:\n\nA) Clinical evaluation:\n\nThe following parameters were evaluated:\n\n1. Modified plaque index:\n\n This is fundamentally based on the visual detection of plaque, it ascertains the thickness of plaque along the gingival margin, namely the desirability of distinguishing clearly between severity and the location of soft debris aggregates.\n2. Modified gingival index:\n\n It is a method to assess the severity of gingivitis based on gingival color, contour, presence of bleeding, stippling and crevicular fluid flow. It is completely noninvasive method (only visual).\n3. Probing depth:\n\nPeri-implant pocket depth was measured using plastic implant probe (contrast PA probe # CPNG22, Helmut Zepf Medizintechnik Gmbh®) after final restoration was inserted.\n\nB) Radiographic evaluation:\n\nBone width was assessed using CBCT 12 months after implant insertion. Bone width measurements were made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest; 2 mm from the alveolar crest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years.\n* Good general health.\n* Able to provide informed consent.\n* Availability for multiple follow up appointments.\n* Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis.\n* The tooth has been extracted from at least 3 months.\n* Insufficient horizontal bone (class III according to Len Tolstunov classification.\n* Good oral hygiene.\n\nExclusion Criteria:\n\n* History of systemic disease that will contraindicate intraoral surgical procedures.\n* Chronic treatment with any medication known to affect oral status and bone turnover.\n* Surgical procedures within 30 days of study initiation.\n* Long term nonsteroidal anti-inflammatory drugs exceeding 100 mg per day.\n* Pregnant or lactating women.\n* Acute dentoalveolar infection\n* Smokers more than 10 cigarettes per day.\n* Uncontrolled or untreated periodontal disease.'}, 'identificationModule': {'nctId': 'NCT06043258', 'acronym': 'BondApatite', 'briefTitle': 'Bond Apatite in Horizontal Augmentation Versus Bio-Oss', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical and Radiographic Assessment of Bond Apatite in Horizontal Bone Augmentation Around Dental Implant', 'orgStudyIdInfo': {'id': 'M07061119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Group I) study group', 'description': 'eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect.', 'interventionNames': ['Other: Bond Apatite']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Group II) positive control group', 'description': 'eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane.', 'interventionNames': ['Other: Bio-Oss']}], 'interventions': [{'name': 'Bond Apatite', 'type': 'OTHER', 'description': 'composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1', 'armGroupLabels': ['(Group I) study group']}, {'name': 'Bio-Oss', 'type': 'OTHER', 'description': 'xenograft bone substitute', 'armGroupLabels': ['(Group II) positive control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damietta', 'country': 'Egypt', 'facility': 'Mohammed Farrag', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}