One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Study Overview
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Brief Summary
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Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK. BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin. The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.

Official Title
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One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Conditions
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Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth

Intervention / Treatment
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* Other: BioHPP PEEK-based single posterior crowns
* Other: Metal ceramic single posterior crowns


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: From 18-50 years old, be able to read and sign the informed consent document. Have no active periodontal or pulpal diseases, have teeth with good restorations Psychologically and physically able to withstand conventional dental procedures Patients with teeth problems indicated for single posterior crowns: Badly decayed teeth Teeth restored with large filling restorations Endodontically treated teeth Malformed teeth Malposed teeth (Tilted, over-erupted, rotated, etc.) Spacing between posterior teeth Able to return for follow-up examinations and evaluation Exclusion Criteria: Patient less than 18 or more than 50 years Patient with active resistant periodontal diseases Patients with poor oral hygiene and uncooperative patients Pregnant women Patients in the growth stage with partially erupted teeth Psychiatric problems or unrealistic expectations Lack of opposing dentition in the area of interest

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metal ceramic single posterior crowns<br>Metal copings veneered with feldspathic porcelain | Other: Metal ceramic single posterior crowns<br>* Standard metal coping veneered with glass ceramics<br>* Other names: Porcelain fused to metal (PFM) or Ceramo-metallic;|
| Experimental: BioHPP PEEK-based single posterior crowns<br>BioHPP PEEK copings veneered with composite resin | Other: BioHPP PEEK-based single posterior crowns<br>* BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture | Measured using modified USPHS criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal adaptation | Measured using modified USPHS criteria | 1 year |