Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06871020
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced vs. PFM Attachments in Distal Extension RPDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-02-22', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Bleeding index', 'timeFrame': 'At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments', 'description': "The bleeding Index will be evaluated at denture insertion and after six months (180 days: Assessed using Mombelli's Bleeding Index, which scores bleeding on probing (BOP) from 0 (no bleeding) to 3 (heavy bleeding)."}, {'measure': 'Evaluation of Probing Pocket Depth (PPD)', 'timeFrame': 'At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments', 'description': 'Evaluation of Probing Pocket Depth (PPD)will be evaluated at denture insertion and after six months: Measured on buccal and lingual aspects of the four abutments following the American Academy of Periodontology protocol. Six readings per abutment will be averaged.'}, {'measure': 'Evaluation of Gingival Recession', 'timeFrame': 'At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments', 'description': 'Evaluation of Gingival Recession: Measured from the cemento-enamel junction (CEJ) to the gingival margin.'}, {'measure': 'Evaluation Gingival Index (GI)', 'timeFrame': 'At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments', 'description': 'Evaluation of Gingival index: Evaluated using Löe and Silness (1963), scoring gingival inflammation from 0 (healthy) to 3 (severe inflammation with spontaneous bleeding).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Patient Satisfaction', 'timeFrame': 'After six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments', 'description': 'Patient satisfaction will be evaluated using the McGill Denture Satisfaction Questionnaire and a visual analog scale (VAS). Satisfaction will be measured across multiple aspects, including ease of cleaning, speech ability, comfort, esthetics, stability, mastication of various foods, masticatory efficiency, oral condition, and overall satisfaction. Patients will rate each item on a 0-100 scale, where 0 represents complete dissatisfaction and 100 indicates total satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD/CAM', 'Fiber Reinforced Composite', 'Denture Precision Attachment', 'Denture, Partial, Removable'], 'conditions': ['Mandibular Distal-extension Prostheses']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to assess periodontal health and patient satisfaction in mandibular distal extension removable partial dentures using CAD/CAM fiber-reinforced composite versus porcelain-fused-to-metal extracoronal attachments. Twelve participants with bilateral mandibular Kennedy Class I, retaining only the first premolars as the last standing abutments, will be randomly assigned to two groups. Group I will receive OT extracoronal attachments made from CAD/CAM fiber-reinforced composite, while Group II will receive OT extracoronal attachments made from porcelain-fused-to-metal. All participants will then receive a metallic removable partial denture. The null hypothesis states that no significant differences will be observed in periodontal health and patient satisfaction between the two attachment types.', 'detailedDescription': 'Twelve participants with bilateral maxillary Kennedy Class I, with the first premolars as the last standing abutments, will be recruited based on strict inclusion criteria from the oral and maxillofacial prosthodontic outpatient clinic. The canines and first premolars will be prepared to receive OT extracoronal attachments made from either CAD/CAM fiber-reinforced composite (Group I) or porcelain-fused-to-metal (Group II), according to group allocation. All participants will then receive a metallic removable partial denture. Periodontal health will be assessed through bleeding index, probing depth, and gingival recession at denture insertion and after six months. Patient satisfaction will also be evaluated at the six-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mandibular partially edentulous bilateral distal extension Kennedy Class I with first premolars as last abutments.\n2. The opposing maxillary arch will be dentate.\n3. Angle class I maxillomandibular skeletal relation.\n4. The distal extension ridge will be well-formed and covered by healthy and firm mucosa.\n5. As verified by periapical radiographs, Abutments have healthy periodontal ligaments and an appropriate crown/root ratio (CRR).\n6. Crown/root ratio of the premolar abutment teeth is not less than 1:1. 5.\n7. The vertical distance between the ridge tissue and the opposing teeth of the study cases is not less than 7 mm. 6.\n8. The buccolingual dimension of the abutment teeth is not less than 6 mm.\n\nExclusion Criteria:\n\n1. Patients with any systemic disease that could affect the rate of bone resorption, which was confirmed by obtaining a through medical history.\n2. Patients with parafunctional habits (bruxism and clenching).\n3. Patients with any septic foci or impacted teeth as proved by panoramic radiograph, as well as patients with tilted or rotated abutments or soft tissue undercuts in areas that will be involved in the RDP design.\n4. Patients with any TMJ problems.\n5. Patients with any neuromuscular diseases.'}, 'identificationModule': {'nctId': 'NCT06871020', 'briefTitle': 'Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced vs. PFM Attachments in Distal Extension RPDs', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced Composite Versus Porcelain Fused to Metal Extracoronal Attachment in Mandibular Distal Extension Removable Partial Dentures: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FDASU-RecIR122439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.', 'description': 'The patient will receive a removable partial denture retained by bilateral OT extracoronal attachments made from CAD/CAM fiber-reinforced composite resin. These attachments will be fabricated on the prepared first premolars and canines on each side.', 'interventionNames': ['Other: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OT Extracoronal attachment made from porcelain-fused-to-metal', 'description': 'The patient will receive a removable partial denture retained by bilateral T Extracoronal attachment made from porcelain-fused-to-metal . These attachments will be fabricated on the prepared first premolars and canines on each side.', 'interventionNames': ['Other: Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal']}], 'interventions': [{'name': 'Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin', 'type': 'OTHER', 'description': 'Bilateral OT extracoronal attachments will be milled from fiber-reinforced composite resin after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.', 'armGroupLabels': ['OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.']}, {'name': 'Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal', 'type': 'OTHER', 'description': 'Bilateral OT attachments manufactured from porcelain fused to metal by conventional technique after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.', 'armGroupLabels': ['OT Extracoronal attachment made from porcelain-fused-to-metal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Omnia M. Refai, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams Univeristy'}, {'name': 'Noha Helmy Hassan Nawar, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams Univeristy'}, {'name': 'Heba A. Salama, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}, {'name': 'Abdel Rahman Maged, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral and Maxillofacial Prosthodontics', 'investigatorFullName': 'Omnia M. Refai', 'investigatorAffiliation': 'Ain Shams University'}}}}