Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-04-14 @ 2:55 AM
Study NCT ID:
NCT05904756
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The patients' satisfaction using a visual analog scale (VAS)", 'timeFrame': '1 year', 'description': 'VAS score include, comfort with prosthesis, ease of cleaning appearance, decreased embarrassment, ease of speaking, general satisfaction of mandibular prosthesis compared to teeth and prosthesis apart of you, and decreased embracing. Higher score indicating increase satisfaction, and lower scores indicating less satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Oral healthy related quality of life (OHRQoL)', 'timeFrame': '1 year', 'description': 'The arabic version of OHRQoL such as, functional limitation, physical pain, psychologic discomfort, psychologic disability, and social disability. For each item of the 14 items were never (= 1), hardly ever (= 2), occasionally (= 3), fairly often (= 4), and very often (= 5). Lower scores indicated higher OHRQoL, vice versa'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis", 'detailedDescription': '10 completely edentulous patients around age of 50-60 years will be selected for this study from the Outpatient Clinic, Faculty of Dentistry, Mansoura University.\n\nAll selected participants will receive a new complete dentures (CD) fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth. The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control, and then, clinical performance and patient satisfaction will be evaluated.\n\nEach participant will receive 4 implants according to the "All-on-4 concept," and the implants will be immediately loaded with mandibular denture. Three months after osseointegration, patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs. Two sets of patients will be made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). The first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received PEKK first, and after 3 months, measurements will be made. Then, PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample size calculation was based on difference in OHIP between CD \\& MB groups retrived from previous research using 2-tailed test , α error =0.05 and power = 90.0% , the total calculated sample size will be 10 cases in each group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient available restorative space (from the proposed occlusal plane to soft tissue • covering residual ridge) of at least 20 mm to accommodate all types of tested prosthesis.\n* They had completely edentulous maxilla and mandible at least six months after the last extraction.\n* Sufficient residual alveolar ridge quantity and quality (D2-D3)\n* Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.\n* Normal maxillo-mandibular relationship.\n\nExclusion Criteria:\n\nAll diseases or syndromes are contraindicated with implant surgery such as:\n\n* General contraindications for surgical procedures such as patients with head and neck radio therapy, patients with bleeding disorders, hepatic patients.\n* Patients with metabolic disorders that affect Osseo integration such as diabetes mellitus, and osteoporosis.\n* Long term immunosuppressive and corticosteroid drug therapy.\n* Abnormal detrimental habits, e.g. bruxism and clenching.\n* Heavy smokers and alcoholic patients.\n* All patients will be informed about the steps involved in this research and they will sign a\n\nwritten consent form of the ethical committee of faculty of dentistry Mansoura University for approval to take part in this research and come to the follow up visits.'}, 'identificationModule': {'nctId': 'NCT05904756', 'briefTitle': 'Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for All-on-four Implant Supported Fixed Detachable Prosthesis: A Crossover Study.', 'orgStudyIdInfo': {'id': 'A0105023RP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metal framework group', 'description': 'Two sets of patients were made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). Conventional complete denture will be fabricated first and patient will wear the denture for 3 months. Then 4 implants will be placed according to all in 4 concept.after 3 months of asseointegration,the first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and oral healthy related quality of lifewill be measured.', 'interventionNames': ['Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone']}, {'label': 'PEKK framework group', 'description': 'metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received polyetherketoneketone first, and after 3 months, measurements will be made. Then, polyetherketoneketone framework will be replaced by Metal framework and measurements( Patient satisfaction and oral healty related quality of life) will be repeated after another 3 months in across over design.', 'interventionNames': ['Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone']}], 'interventions': [{'name': 'framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone', 'type': 'DEVICE', 'description': 'evaluation of patient satisfaction and oral healty related quality of life', 'armGroupLabels': ['Metal framework group', 'PEKK framework group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Salah A. Hegazy, PhD', 'role': 'CONTACT', 'email': 'salahhegazy2003@yahoo.com', 'phone': '00201227690209'}, {'name': 'mohamed Elsawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@std.mans.edu.eg', 'phone': '01061314522'}, {'name': 'Islam Kandil, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mostafa Sowidan, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdelfatah soliman, BDS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of dentistry , Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohammed E Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '+201061314522'}, {'name': 'Salah A Hegazy, PhD', 'role': 'CONTACT', 'email': 'salahhegazy@yahoo.com', 'phone': '01227690209'}], 'overallOfficials': [{'name': 'Mohammed E Sawy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer, Department of prosthodontics, principle investigator', 'investigatorFullName': 'Mohamed Elsawy', 'investigatorAffiliation': 'Mansoura University'}}}}