Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT07250503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusal force distribution', 'timeFrame': 'Follow up visits were scheduled at denture insertion, 6, and 12 months', 'description': "Occlusal force distribution will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion and disocclusion times"}], 'secondaryOutcomes': [{'measure': 'Retention of lower denture', 'timeFrame': 'Follow up visits were scheduled at denture insertion, 6, and 12 months', 'description': 'Retention of lower denture will be measured using digital force gauge, Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.'}, {'measure': 'occlusion time', 'timeFrame': 'Follow up visits were scheduled at denture insertion, 6, and 12 months', 'description': "occlusion and disocclusion time will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion times"}, {'measure': 'Biting force', 'timeFrame': 'Follow up visits were scheduled at denture insertion, 6, and 12 months', 'description': 'Biting force will be measured by bite force meter'}, {'measure': 'Disocclusion time', 'timeFrame': 'Follow up visits were scheduled at denture insertion, 6, and 12 months', 'description': "will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for disocclusion times"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Completely edentulous patients', 'Dental Implants', 'Edentulous Ridge'], 'conditions': ['Edentulous Alveolar Ridge In Mandible', 'Complete Edentulism', 'Dental Implant', 'Attachments', 'Implant Retained Overdenture', 'Edentulous Mouth']}, 'descriptionModule': {'briefSummary': 'The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional dentures. Among available attachment systems-bar, ball, stud, and magnet-the Equator attachment has gained popularity due to its low vertical profile, suitability for limited inter-occlusal space, and ease of handling.\n\nAssessment of masticatory performance and occlusal balance can be objectively measured using devices such as bite force analyzers and the computerized T-Scan system, which quantifies occlusion and disocclusion times.\n\nConventional heat-cured polymethyl methacrylate (PMMA) remains the most widely used denture base material; however, it has mechanical and biological limitations. Flexible denture base materials have been introduced to overcome these drawbacks by enhancing adaptation, distributing occlusal loads more evenly, and improving comfort and retention.', 'detailedDescription': '24 Patients will be randomly and equally divided into two treatment groups:\n\n1. Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin PMMA. In the mandible, two implants were inserted in the symphyseal area and retained by equator attachments.\n2. Group 2: Patients in this group received the same type of treatment as the patients in group 1, but the mandibular overdentures were made of the flexible acrylic resin "breflex" The present study will be performed to compare the difference in retention, occlusal force distribution, occlusion and disocclusion time, and bite force for implant retained mandibular over denture using PMMA and flexible dentures base materials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. All patients age must range from 60-70 years old.\n2. All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.\n3. Patients should be free from any metabolic or bone disorder that contraindicate implant installation.\n4. All patients must have sufficient inter arch space\n\nExclusion Criteria:\n\n1. Patients with oral or systemic diseases.\n2. Patients with xerostomia or excessive salivation.\n3. Patients with parafunctional habits (bruxism or clenching).\n4. Heavy smoker or alcoholic patients.\n5. Patients with history of temporo-mandibular dysfunction.\n6. Patients with brain disorders or psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT07250503', 'briefTitle': 'Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Impact of Wearing Two Different Implant Retained Mandibular Overdentures on Occlusal Force Distribution and Denture Retention (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '28.4.24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mandibular complete dentures processed into heat cured acrylic resin', 'description': 'Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.', 'interventionNames': ['Procedure: Conventional acrylic resin denture']}, {'type': 'EXPERIMENTAL', 'label': 'Mandibular thermoplastic nylon denture', 'description': 'Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.', 'interventionNames': ['Procedure: Flexible resin denture']}], 'interventions': [{'name': 'Conventional acrylic resin denture', 'type': 'PROCEDURE', 'description': 'Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.', 'armGroupLabels': ['Mandibular complete dentures processed into heat cured acrylic resin']}, {'name': 'Flexible resin denture', 'type': 'PROCEDURE', 'description': 'Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments', 'armGroupLabels': ['Mandibular thermoplastic nylon denture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4470351', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Start Date: After publication End Date: 3 years', 'ipdSharing': 'YES', 'description': 'Study Protocol and Clinical Study Report', 'accessCriteria': 'After publication through the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Noha Taha Kamel Taha Alloush', 'investigatorAffiliation': 'Misr International University'}}}}