Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT07208812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D-Printed Implant Overdentures: Comparing Impression Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-27', 'studyFirstSubmitQcDate': '2025-09-27', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Masticatory efficiency', 'timeFrame': '3, 6, and 9 months after overdenture insertion', 'description': 'Assessment of chewing efficiency using a color- mixing ability test'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '3, 6, and 9 months after overdenture insertion', 'description': 'Patient- reported satisfaction measured using the Visual Analog Scale (VAS; range 0-10, where 0=not satisfied at all and 10= completely satisfied )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D-Printed Implant Overdenture', 'Impression Techniques', 'Chewing Efficiency', 'Patient Satisfaction'], 'conditions': ['Edentulism']}, 'descriptionModule': {'briefSummary': 'This randomized crossover clinical trial aims to compare three different impression techniques for the construction of 3d-printed mandibular implant overdentures in completely edentulous patients. Sixteen patients will receive two mandibular implants and three overdentures fabricated using:(1) conventional open-tray implant level impression (2) functionally generated reline impression, and (3)mucostatic base with functional borders impression. Each overdenture will be worn for three months with a washout period between interventions.\n\nThe primary outcome is masticatory efficiency, assessed using a color -mixing ability test at 3,6, and9 months.\n\nSecondary outcome is patient satisfaction, assessed using a Visual Analog Scale (VAS) at the same intervals. the study hypothesis is that the impression technique influences both chewing efficiency and patient satisfaction', 'detailedDescription': 'Edentulism has a significant impact on oral function and quality of life. The use of mandibular implant overdentures supported by two implants is widely considered the minimum standard of care, providing improved stability, function, and patient satisfaction compared with conventional complete dentures. Recently, digital workflows and additive manufacturing (3D printing) have created new opportunities for fabricating complete dentures with improved efficiency and reduced costs.\n\nSeveral impression techniques are currently available for implant-retained overdentures, but there is limited evidence on how these techniques influence functional outcomes and patient-reported satisfaction, particularly when using 3D-printed prostheses.\n\nThis randomized crossover clinical trial will be conducted at the Faculty of Dentistry, Mansoura University. Sixteen completely edentulous patients aged 45-70 years will receive two implants placed in the mandibular canine region. After the osseointegration period, each participant will be provided with three different mandibular implant overdentures fabricated using different impression techniques:\n\n1. Conventional open-tray implant-level impression\n2. Functionally generated reline impression\n3. Mucostatic base with functional borders impression Each overdenture will be worn for a period of three months, with a two-week washout period using a provisional denture before switching to the next overdenture. Randomization will determine the sequence of interventions for each patient.\n\nThe primary outcome is masticatory efficiency, measured with a color-mixing ability test at 3, 6, and 9 months. The secondary outcome is patient satisfaction, measured using a Visual Analog Scale (VAS) at the same intervals.\n\nThe study is designed to provide evidence on whether the choice of impression technique affects clinical and patient-centered outcomes in 3D-printed mandibular implant overdentures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy patients, free from systemic diseases that affect bone resorption (e.g., uncontrolled diabetes, osteoporosis)\n* Residual alveolar ridges covered with healthy, firm mucosa\n* Adequate mandibular bone length and width to accommodate standard implant sizes.\n* Angle's Class I maxillo-mandibular relationship.\n\nExclusion Criteria:\n\n* Absolute contraindications to implant placement (e.g., active cancer, immune system diseases)\n* History of head and neck irradiation or chemotherapy within the past 3 years\n* Metabolic bone diseases such as uncontrolled diabetes, osteoporosis, or hyperparathyroidism\n* Parafunctional habits such as bruxism or clenching\n* Smoking or alcoholism\n* Any physical or medical condition that may interfere with study follow-up or implant success"}, 'identificationModule': {'nctId': 'NCT07208812', 'briefTitle': '3D-Printed Implant Overdentures: Comparing Impression Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Impact of Impression Techniques on Patient Satisfaction and Chewing Efficiency in 3D-Printed Implant Overdentures: A Crossover Study', 'orgStudyIdInfo': {'id': 'MS.25.05.25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional open -tray impression', 'description': 'Mandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level.', 'interventionNames': ['Procedure: Conventional open -tray impression']}, {'type': 'EXPERIMENTAL', 'label': 'Functionally generated reline impression', 'description': 'Mandibular implant overdenture fabricated using functionally generated reline impression technique.', 'interventionNames': ['Procedure: Functionally generated reline impression']}, {'type': 'EXPERIMENTAL', 'label': 'Mucostatic base with functional borders impression', 'description': 'Mandibular implant overdenture fabricated using mucostatic base and functional borders impression technique.', 'interventionNames': ['Procedure: Mucostatic base with functional borders impression']}], 'interventions': [{'name': 'Conventional open -tray impression', 'type': 'PROCEDURE', 'description': 'Primary impression with irreversible hydrocolloid, custom tray with open window, and final impression with silicone material around impression copings to fabricate a 3D-printed implant overdenture', 'armGroupLabels': ['conventional open -tray impression']}, {'name': 'Functionally generated reline impression', 'type': 'PROCEDURE', 'description': 'Interim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture', 'armGroupLabels': ['Functionally generated reline impression']}, {'name': 'Mucostatic base with functional borders impression', 'type': 'PROCEDURE', 'description': 'Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture', 'armGroupLabels': ['Mucostatic base with functional borders impression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Shimaa E Aboelenin', 'role': 'CONTACT', 'email': 'shimaaaboelenin@mans.edu.eg', 'phone': '01113786860'}], 'facility': 'Faculty of Dentistry, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Shimaa E Aboelenin', 'role': 'CONTACT', 'email': 'shimaaaboelenin@mans.edu.eg', 'phone': '01113786860'}], 'overallOfficials': [{'name': 'Shimaa E Aboelenin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical demonstrator at prosthodontics department', 'investigatorFullName': 'Shimaa Ebrahim Abo Elenin Ebrahim', 'investigatorAffiliation': 'Mansoura University'}}}}