Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT03026894
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Force Distribution and Bone Resorption
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011862', 'term': 'Radiography, Panoramic'}], 'ancestors': [{'id': 'D011861', 'term': 'Radiography, Dental'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003945', 'term': 'Diagnosis, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual ridge resorption', 'timeFrame': '7 years', 'description': 'To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.'}], 'secondaryOutcomes': [{'measure': 'Occlusal force distribution', 'timeFrame': '1 year', 'description': 'To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bone Resorption']}, 'descriptionModule': {'briefSummary': 'To investigate the residual ridge resorption at anterior and posterior maxillary and posterior mandibular ridges among conventional complete dentures and implant overdenture wearers, and determine its association with the relative occlusal forces distribution, treatment groups and other patient variables.', 'detailedDescription': 'A total of forty-six edentulous patients participated in this clinical study divided into two groups as following; complete denture group (CD) consists of 23 patients wearing conventional complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical bone area and the reference area in the maxillary and the mandibular ridges. The occlusal contacts percentage of force in maximum intercuspation anteriorly and posteriorly were recorded for both groups by using T-Scan III system.\n\nOral and written information in English or Malay language, regarding the study, was provided and written consent obtained before enrolment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '49 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients wearing mandibular IODs opposing conventional maxillary CDs.\n* Patients wearing conventional maxillary and mandibular CDs.\n* Clearly visible anatomic landmarks of the panoramic radiography image.\n\nExclusion Criteria:\n\n* Patients with a history of temporomandibular joint dysfunction.'}, 'identificationModule': {'nctId': 'NCT03026894', 'briefTitle': 'Association of Force Distribution and Bone Resorption', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures', 'orgStudyIdInfo': {'id': 'PG012-2014A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CD group', 'description': 'Panoramic Radiographs and T-Scan III occlusal system', 'interventionNames': ['Radiation: Panoramic Radiograph', 'Device: T-Scan III occlusal system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IOD group', 'description': 'Panoramic Radiographs and T-Scan III occlusal system', 'interventionNames': ['Radiation: Panoramic Radiograph', 'Device: T-Scan III occlusal system']}], 'interventions': [{'name': 'Panoramic Radiograph', 'type': 'RADIATION', 'description': 'Measurement of bone resorption', 'armGroupLabels': ['CD group', 'IOD group']}, {'name': 'T-Scan III occlusal system', 'type': 'DEVICE', 'description': 'Recording percentage of force in maximum intercuspation', 'armGroupLabels': ['CD group', 'IOD group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}