Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03212820
Status:
UNKNOWN
Last Update Posted:
2017-07-11
First Post:
2017-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group B ) A Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'crestal bone loss', 'timeFrame': '6 month', 'description': 'measurement from radiographic analysis using digital periapical x-ray'}], 'secondaryOutcomes': [{'measure': 'patient morbidity after procedure', 'timeFrame': '1 day', 'description': 'pain value on pain scale'}, {'measure': 'Implant stability value', 'timeFrame': '3 month', 'description': 'resonance frequency analysis using osstell'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Resorption']}, 'descriptionModule': {'briefSummary': '20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)\n\n* for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .\n* In the study group: implant will be inserted in the low speed osteotomy site.\n* In the control group: implants will be inserted in the conventional prepared osteotomy site.\n* For both groups there is no surgical guide used.\n* The flap will then be copiously irrigated with saline in preparation for closure.\n* The flap will then be closed using interrupted 4/0 resorbable sutures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients restoring missing maxillary teeth with implant placement.\n* Both sexes.\n* Age: 25-45\n* Mesio-distal dimensions: Not less than 6 mm\n* Bone Height: Not less than 12 mm\n* Bucco-lingual dimensions: Not less than 8mm\n* All measures will be assessed using CBCT.\n\nExclusion Criteria:\n\n* Sites needing bone grafting or augmentation.\n* Heavy smokers more than 20 cigarettes per day.\n* Patients with systemic disease that may affect normal healing.'}, 'identificationModule': {'nctId': 'NCT03212820', 'briefTitle': 'Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group B ) A Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Cebc.cairoun'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biologic drilling', 'description': 'drilling at low speed', 'interventionNames': ['Procedure: Drilling at low speed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional drilling', 'description': 'drilling at conventional or high speed', 'interventionNames': ['Procedure: Drilling at conventional or high speed']}], 'interventions': [{'name': 'Drilling at low speed', 'type': 'PROCEDURE', 'armGroupLabels': ['Biologic drilling']}, {'name': 'Drilling at conventional or high speed', 'type': 'PROCEDURE', 'armGroupLabels': ['conventional drilling']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ahmed Tarek', 'investigatorAffiliation': 'Cairo University'}}}}