Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:12 PM
Study NCT ID:
NCT02507661
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C485817', 'term': 'beta-tricalcium phosphate'}, {'id': 'D003094', 'term': 'Collagen'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant stability analysis at the time of implant placement', 'timeFrame': 'baseline', 'description': 'Implant stability will be measured by the resonance frequency analysis'}, {'measure': 'implant stability analysis 3 weeks after implant placement', 'timeFrame': 'baseline, 3 weeks', 'description': 'Implant stability will be measured by the resonance frequency analysis'}, {'measure': 'implant stability analysis 6 weeks after implant placement', 'timeFrame': 'baseline, 6 weeks', 'description': 'Implant stability will be measured by the resonance frequency analysis'}, {'measure': 'implant stability analysis 8 weeks after implant placement', 'timeFrame': 'baseline, 8 weeks', 'description': 'Implant stability will be measured by the resonance frequency analysis'}, {'measure': 'change in pink and white esthetic score 2 months of loading', 'timeFrame': '2 months', 'description': 'Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns'}, {'measure': 'change in pink and white esthetic score 6 months of loading', 'timeFrame': '6 months', 'description': 'Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns'}, {'measure': 'change in pink and white esthetic score 12 months of loading', 'timeFrame': '12 months', 'description': 'Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns'}], 'secondaryOutcomes': [{'measure': 'analysis of new bone formation 2 months after preservation of alveolar ridge', 'timeFrame': '2 months', 'description': 'New bone formation will be assessed by histological analysis and histomorphometrical measurement'}, {'measure': 'analysis of new bone formation 4 months after preservation of alveolar ridge', 'timeFrame': '4 months', 'description': 'New bone formation will be assessed by histological analysis and histomorphometrical measurement'}, {'measure': 'analysis of new bone formation 9 months after preservation of alveolar ridge', 'timeFrame': '9 months', 'description': 'New bone formation will be assessed by histological analysis and histomorphometrical measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Partial Edentulism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy patients according to Classification of American Society of Anesthesiologists (ASA I)\n* presence of 4 socket walls\n* non-smokers\n* good oral hygiene\n* good occlusion\n\nExclusion Criteria:\n\n* patients with alveolar ridge height less than 12 mm\n* presence of acute or chronic oro-facial pain\n* acute periapical infection\n* injured soft tissue\n* patients who had dental interventions in last 7 days\n* patients who had any medications within last 24 hours\n* patients with bruxism and para-functions\n* patients with allergies to any of applied materials'}, 'identificationModule': {'nctId': 'NCT02507661', 'briefTitle': 'Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone', 'orgStudyIdInfo': {'id': '36/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alveolar ridge preservation - 2 months', 'description': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months', 'interventionNames': ['Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no-preservation of alveolar ridge - 2 months', 'description': 'no-preservation of alveolar ridge - 2 months', 'interventionNames': ['Drug: no-preservation of alveolar ridge - 2 months']}, {'type': 'EXPERIMENTAL', 'label': 'preservation of alveolar ridge - 4 months', 'description': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months', 'interventionNames': ['Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no-preservation of alveolar ridge - 4 months', 'description': 'no-preservation of alveolar ridge - 4 months', 'interventionNames': ['Drug: no-preservation of alveolar ridge - 4 months']}, {'type': 'EXPERIMENTAL', 'label': 'preservation of alveolar ridge - 9 months', 'description': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months', 'interventionNames': ['Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no-preservation of alveolar ridge - 9 months', 'description': 'no-preservation of alveolar ridge - 9 months', 'interventionNames': ['Drug: no-preservation of alveolar ridge - 9 months']}], 'interventions': [{'name': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months', 'type': 'DRUG', 'armGroupLabels': ['alveolar ridge preservation - 2 months']}, {'name': 'no-preservation of alveolar ridge - 2 months', 'type': 'DRUG', 'armGroupLabels': ['no-preservation of alveolar ridge - 2 months']}, {'name': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months', 'type': 'DRUG', 'armGroupLabels': ['preservation of alveolar ridge - 4 months']}, {'name': 'no-preservation of alveolar ridge - 4 months', 'type': 'DRUG', 'armGroupLabels': ['no-preservation of alveolar ridge - 4 months']}, {'name': 'preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months', 'type': 'PROCEDURE', 'armGroupLabels': ['preservation of alveolar ridge - 9 months']}, {'name': 'no-preservation of alveolar ridge - 9 months', 'type': 'DRUG', 'armGroupLabels': ['no-preservation of alveolar ridge - 9 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'School of Dental Medicine, University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Bozidar M Brkovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dental Medicine, University of Belgrade'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS PhD Professor', 'investigatorFullName': 'Bozidar Brkovic, DDS, MSc, PhD, Professor', 'investigatorAffiliation': 'University of Belgrade'}}}}