Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06201169
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'each participant enrolled in the study randomly and the results of both groups were serialized and assessed by the outcome assessor'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'completely edentulous mandibular arch opposing natural dentition were selected'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographically (digital periapical)', 'timeFrame': 'six and twelve months', 'description': 'marginal bone loss around the implants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hybrid prosthesis, Polyether-ether-ketone,'], 'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.', 'detailedDescription': 'Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old.\n\nand normal class Ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space\n\nExclusion Criteria:\n\n* All patient had systemic disorders that may influence soft or hard tissue healing were excluded as:\n\n * History of radiation therapy in the head and neck region.\n * Active infection or inflammation or flabby tissue in the mandibular arch\n * Bone diseases as osteoporosis.\n * Clenching or bruxism, temporomandibular joint troubles\n * Neurological or psychiatric handicap conditions that could interfere with good oral hygiene.\n * Heavy smoking and drug abusing'}, 'identificationModule': {'nctId': 'NCT06201169', 'briefTitle': 'PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study of PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses', 'orgStudyIdInfo': {'id': 'REC 02-21 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group I (control)', 'description': 'The bars are fabricated from titanium. the participants received implant supported hybrid prosthesis with CAD/CAM fabricated titanium bars', 'interventionNames': ['Procedure: implant placement']}, {'type': 'EXPERIMENTAL', 'label': 'group II', 'description': 'The bars are fabricated from PEEK . the participants received implant supported hybrid prosthesis with CAD/CAM fabricated PEEK bars', 'interventionNames': ['Procedure: implant placement']}], 'interventions': [{'name': 'implant placement', 'type': 'PROCEDURE', 'description': 'All patients received four implants in the lower arch', 'armGroupLabels': ['group I (control)', 'group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Al Gharbī Bahjūrah', 'state': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of dentistry tanta university', 'geoPoint': {'lat': 26.01667, 'lon': 32.21667}}, {'zip': '31527', 'city': 'Al Gharbī Bahjūrah', 'state': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 26.01667, 'lon': 32.21667}}], 'overallOfficials': [{'name': 'Research Ethics committee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amr Azab Abd El-Fattah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assiatant lecturer', 'investigatorFullName': 'Amr Azab Abd El-Fattah', 'investigatorAffiliation': 'Tanta University'}}}}