Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT06882161
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2025-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C438105', 'term': 'acetalic resin, Acetal-Dental'}, {'id': 'C063834', 'term': 'polyetheretherketone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '(patients and assessors)'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was a parallel, two-group, double-blinded, randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket Depth', 'timeFrame': '6 months', 'description': 'assessing the pocket depth (PD) of abutment teeth'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': '6 months', 'description': 'assessing the plaque index (PI) of abutment teeth'}, {'measure': 'Gingival index', 'timeFrame': '6 months', 'description': 'assessing the gingival index (GI) of abutment teeth'}, {'measure': 'Abutment alveolar bone height change.', 'timeFrame': '6 months', 'description': 'assessing the Abutment alveolar bone height of abutment teeth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate and compare the effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI). Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change.', 'detailedDescription': "This study was a parallel, two-group, double-blinded, randomized clinical trial. The proposal and consents were approved by the Research Ethics Committee. (REC) approval (P-PD-14-14). The Helsinki Declaration's guiding principles were followed when conducting the study. The Comprehensive Standards of Reporting Trials Statement (CONSORT) checklist's structure is followed in the study's presentation. The study was carried out at the Outpatient Clinic of the Removable Prosthodontic Department within the Faculty of Dental Medicine for Girls at Al-Azhar University.\n\nIn this study, fifty patients were initially evaluated. After conducting clinical and radiographic assessments, twenty patients who satisfied the inclusion criteria were selected in accordance with the sample size calculation. Each patient received an explanation of every procedure, and informed consent was obtained. These twenty individuals were subsequently divided randomly into two distinct groups (ten in each):\n\nGroup I: Ten patients received polyoxymethylene (acetal resin) partial dentures designed and fabricated using CAD/CAM technology. Group II: Ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.\n\nAll patients were evaluated clinically and radiographically. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI) at denture insertion, three months later and six months later. Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change at the time of denture placement, after three months, and after six months."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Every subject should be free of any systemic diseases that might influence the results of the research.\n* Patient's residual ridges should be covered with healthy mucosa.\n* Their salivary flow and viscosity for all within normal limits.\n* The patients are cooperative and ready to be called back as necessary.\n* had a Class I Angle's ridge relation\n\nExclusion Criteria:\n\n* Alcoholic or smokers' patients.\n* Patients with xerostomia or excessive salivation.\n* Patients with parafunctional habits.\n* Patients with ulcerated or inflamed mucosa."}, 'identificationModule': {'nctId': 'NCT06882161', 'briefTitle': 'Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth in Mandibular Kennedy Class I Partial Dentures Manufactured by CAD-CAM Technology', 'orgStudyIdInfo': {'id': 'P-PD-14-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetal resin partial dentures', 'description': 'ten patients received acetal resin partial dentures designed and fabricated using CAD/CAM technology', 'interventionNames': ['Biological: Acetal resin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEEK partial dentures', 'description': 'ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.', 'interventionNames': ['Biological: Acetal resin']}], 'interventions': [{'name': 'Acetal resin', 'type': 'BIOLOGICAL', 'otherNames': ['PEEK'], 'description': 'Effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases', 'armGroupLabels': ['Acetal resin partial dentures', 'PEEK partial dentures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19519', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Yasmin S Zidan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer at faculty of dental medicine for girls , Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yasmin S. Zidan', 'investigatorFullName': 'Yasmin Seif Eldeen Zidan', 'investigatorAffiliation': 'Al-Azhar University'}}}}