PEEK Retentive Elements Versus Conventional

Study Overview
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Brief Summary
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comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings

Detailed Description
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Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures. Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings. Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.

Official Title
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Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial

Conditions
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Partially Edentulous Mandible

Intervention / Treatment
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* Other: PEEK retentive elements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders Exclusion Criteria: exposed to radiotherapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional retentive element<br>The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, | Other: PEEK retentive elements<br>* received implant-supported mandibular overdenture retained by PEEK retentive element and housings<br>* Other names: PEEK housing and clip;|
| Experimental: PEEK retentive element<br>PEEK group received implant-supported mandibular overdentures retained by PEEK housings , | Other: PEEK retentive elements<br>* received implant-supported mandibular overdenture retained by PEEK retentive element and housings<br>* Other names: PEEK housing and clip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention | measuring retention force of retentive elements using The force-meter machine (Eagle: ELT 3000) . Gradual pulling up force was applied. The record appeared at the screen of the force meter was recorded as it's single-blind measurements. | 3 months to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | measuring patient satisfaction using Visual analog scale (VAS) was used for the evaluation of overall patient satisfaction. All questionnaires were taken by the same research interviewer (assisted interviewer) as he was blind about the type of prosthesis (double-blind) as the research interviewer is from another department | 3 months to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.