Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-07 @ 9:27 PM
Study NCT ID:
NCT01503593
Status:
UNKNOWN
Last Update Posted:
2012-05-30
First Post:
2011-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Combination of Synthetic Bone Substitutes During Extractions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-05-26', 'releaseDate': '2015-05-10'}, {'resetDate': '2018-05-10', 'releaseDate': '2018-04-10'}], 'estimatedResultsFirstSubmitDate': '2015-05-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-28', 'studyFirstSubmitDate': '2011-12-18', 'studyFirstSubmitQcDate': '2012-01-03', 'lastUpdatePostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of the dimension of the alveolar ridge', 'timeFrame': 'Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction', 'description': 'Measurement of socket width (aspect B/L) at three points Height:\n\n1. Record-high ridge (buccal/lingual-palatal )\n2. 3 mm apically to the peak ridge (buccal/lingual-palatal )\n3. 6mm apically to the peak ridge (buccal/lingual-palatal )\n\nMeasurement of alveolar ridge height:\n\nMeasured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth'}], 'secondaryOutcomes': [{'measure': 'Post operative adverse effects', 'timeFrame': 'immediate after the extraction and until 4 monthes after', 'description': 'The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Dental Caries', 'Alveolar Bone Losses']}, 'descriptionModule': {'briefSummary': 'The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.', 'detailedDescription': 'Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients over age 18.\n2. Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).\n\nExclusion Criteria:\n\n1. Inability to pass informed consent procedure\n2. Pregnant women\n3. Breastfeeding women\n4. Patient taking medications that affect bone metabolism such as bisphosphonates\n5. Extractions sites contaminated\n6. Smoking over 10 cigarettes a day\n7. Patients with removable prostheses'}, 'identificationModule': {'nctId': 'NCT01503593', 'briefTitle': 'Using Combination of Synthetic Bone Substitutes During Extractions', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions', 'orgStudyIdInfo': {'id': '0326-11-RMB'}, 'secondaryIdInfos': [{'id': '0362-11-RMB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Alveolar ridge dimensions', 'description': 'Control group - Only extraction teeth'}, {'type': 'EXPERIMENTAL', 'label': 'Alverolar ridge dimension', 'description': 'Extraction of teeth and implant a bone substitute', 'interventionNames': ['Device: Calcium Phosphate, Calcium Sulphate']}], 'interventions': [{'name': 'Calcium Phosphate, Calcium Sulphate', 'type': 'DEVICE', 'description': '1cc of Calcium Phosphate and 1cc of Calcium Sulphate', 'armGroupLabels': ['Alverolar ridge dimension']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr. Yaniv Mayer, DMD', 'role': 'CONTACT', 'email': 'dr.yaniv.mayer@gmail.com', 'phone': '+972546565905'}], 'overallOfficials': [{'name': 'Yaniv Mayer, D.M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-10', 'type': 'RELEASE'}, {'date': '2015-05-26', 'type': 'RESET'}, {'date': '2018-04-10', 'type': 'RELEASE'}, {'date': '2018-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rambam Health Care Campus'}}}}