protocolSection identificationModule nctId: NCT06388395, orgStudyIdInfo id: REC-23-05-12-02-F, briefTitle: Clinical Performance of All-on-4 PEEK and Conventional Prostheses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-08-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Sharjah, class: OTHER, descriptionModule briefSummary: The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success., conditionsModule conditions: Failure, Prosthesis, conditions: Dental Prosthesis, Implant-Supported, conditions: Survival, Prosthesis, conditions: Complete Edentulism, conditions: Complication;Prostheses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups will be provided with two types of implant-supported prostheses, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Accuracy of full-arch surgical guides, interventions name: Survival and complications of the prostheses, interventions name: Survival and complications of the implants, interventions name: Conventional (metal-resin) implant-supported prosthesis, interventions name: PEEK implant-supported prosthesis, outcomesModule primaryOutcomes measure: Accuracy of full-arch surgical guides, primaryOutcomes measure: Survival rate of implants, primaryOutcomes measure: Success rates of the Prostheses, primaryOutcomes measure: Pain level, secondaryOutcomes measure: Marginal bone loss, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Pocket depth, secondaryOutcomes measure: Bleeding index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Sharjah, city: Sharjah, zip: 7724, country: United Arab Emirates, geoPoint lat: 25.33737, lon: 55.41206, hasResults: False