Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT06206005
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes
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': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crestal bone loss around implants', 'timeFrame': 'This is a retrospective study, Measurement will be performed after implants being in service by 10 years', 'description': 'amount of bone loss which appears on a periapical radiograph'}], 'secondaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'This is a retrospective study, Measurement will be performed after implants being in service by 10 years', 'description': 'By using a plastic periodontal probe to measure the probing depth around the implants'}]}, 'oversightModule': {'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Resorption']}, 'descriptionModule': {'briefSummary': 'Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.', 'detailedDescription': 'Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients.\n\nStudies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20 participants at least.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with edentulous maxilla and mandible for at least 12 months.\n* Patients have problems with mandibular denture retention and stability.\n* Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.\n\nExclusion Criteria:\n\n* Patients who did not receive implants at the department clinic.\n* Patients with more or less than 4 implants in the mandible.\n* Patients with well controlled diabetics.\n* Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.\n* Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.'}, 'identificationModule': {'nctId': 'NCT06206005', 'briefTitle': 'Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical and Radiographic Outcomes Around Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes: A Long-term Retrospective Preliminary Study', 'orgStudyIdInfo': {'id': 'A03012023RP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1 with Haemoglobin A1c ≤6.5%', 'description': 'This group represents a well-controlled type 2 Diabetics mellitus.', 'interventionNames': ['Other: Observational study']}, {'label': 'Group 2 with Haemoglobin A1c >6.5%', 'description': 'This group represents a poorly controlled type 2 Diabetics mellitus.', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.', 'armGroupLabels': ['Group 2 with Haemoglobin A1c >6.5%', 'Group1 with Haemoglobin A1c ≤6.5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Elsawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '00201061314522'}, {'name': 'Doaa A. Mewafy, PhD', 'role': 'CONTACT', 'email': 'Doaamowafy@mans.edu.eg', 'phone': '00201061133971'}, {'name': 'Sherine Donia, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mohammed ELSawy', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohammed Elsawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '00201061314522'}, {'name': 'Doaa A. mewafy, PhD', 'role': 'CONTACT', 'email': 'Doaamowafy@mans.edu.eg', 'phone': '00201061133971'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD is upon request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menoufia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer, Department of prosthodontics, principle investigator', 'investigatorFullName': 'Mohamed Elsawy', 'investigatorAffiliation': 'Mansoura University'}}}}