An interventional study of PEEK (Polyetheretherketone) screw-retained implant restoration veneered with composite and Monolithic zirconia screw-retained implant restoration in Partial Edentulism Class IV, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Cairo University · Not applicable, Interventional, and Other
This study compares two different materials used for screw-retained dental implant restorations in the front of the upper jaw (the "esthetic zone"). The goal is to determine which material is better at preserving the bone level around the implant over time and how this will affect the survival rate of the restorations
Purpose of the Study
The primary purpose of this randomized controlled clinical trial is to compare two specific materials used for screw-retained dental implant restorations in the "esthetic zone" (the front of the upper jaw) to see which one better preserves the surrounding bone.
Core Research Objective
The study aims to evaluate whether PEEK (Polyetheretherketone) veneered with composite is superior to monolithic zirconia in decreasing marginal bone loss around dental implants.
The Scientific Rationale
Researchers are investigating these materials for several key reasons:
Primary and Secondary Outcomes
To fulfill this purpose, the study measures two main factors:
Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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The "gold standard" or comparator group (Control Group) consists of Monolithic Zirconia screw-retained restorations. The specific intervention for this group includes the following steps: Surgical Phase: Each participant receives two dental implants installed in the esthetic areas of the maxillary arch. Surgical Guidance: The implants are prosthetically driven and installed with the help of digitally constructed surgical guides. Provisional Phase: Temporary (provisional) restorations are loaded immediately after implant insertion and worn during the healing phase. Final Restoration: After three months of healing, the final fixed partial denture-made of monolithic zirconia-is inserted. Workflow: The entire process follows a fully digital workflow. Maintenance: Patients receive regular maintenance instructions and are recalled for follow-up assessments
Procedure: Monolithic zirconia screw-retained implant restoration
In this clinical trial, the intervention group receives \*\*PEEK (Polyetheretherketone) screw-retained restorations veneered with composite\*\* The specific steps and components for this group include: * Implant Placement:\*\* Each participant receives two dental implants in the upper front (maxillary esthetic) zone. * Surgical Guidance:\*\* The implants are placed using a prosthetically driven approach with the aid of digitally constructed surgical guides. * Provisional Loading:\*\* Temporary restorations are loaded immediately after the implants are inserted and worn throughout the healing phase. * Final Restoration:\*\* After three months of healing, the final fixed partial denture-made of PEEK and veneered with "Visio-lign" composite-is inserted. * Digital Workflow:\*\* The design and fabrication of the restoration follow a fully digital CAD/CAM workflow. * Monitoring:\*\* The health of the bone around the implants is measured using digital X-rays at 6 and 12 months
Procedure: PEEK (Polyetheretherketone) screw-retained implant restoration veneered with composite
To distinguish the interventions in this specific study from those in other clinical trials, the following unique technical and procedural details should be noted: * Specific Material Combination:\*\* The primary intervention uses PEEK (Polyetheretherketone) specifically veneered with \*\*Visio-lign composite\*\*, a combination chosen to mimic the elastic modulus of human bone and reduce stress shielding. * Targeted Anatomical Site:\*\* The study is exclusively limited to the \*\*maxillary esthetic zone\*\* (upper front teeth), where both mechanical stress and esthetic demands are highest. * Fully Digital Workflow:\*\* Unlike studies that may use conventional impressions, this protocol utilizes a \*\*fully digital workflow\*\*, including digital intraoral scans and CAD/CAM fabrication for both the PEEK and zirconia restorations. * Prosthetically Driven Surgical Guidance:\*\* The placement of the two implants is "prosthetically driven," meaning the final tooth position dictates the surgey
Also known as: PEEK
In this study, the \*\*comparator group\*\* (the control group) receives a \*\*monolithic zirconia screw-retained restoration\*\*. This group serves as the standard clinical benchmark against which the experimental PEEK-composite material is measured. The specific details that distinguish this intervention from others include: * Material Selection:\*\* The restoration is made of \*\*monolithic zirconia\*\*, a high-strength ceramic known for its biocompatibility and esthetic potential, but which is significantly more rigid than the experimental PEEK material. * Fully Digital CAD/CAM Workflow:\*\* Unlike traditional methods, the zirconia restoration is designed and fabricated using a \*\*fully digital workflow\*\*, including digital intraoral scans and computer-aided manufacturing. * Specific Anatomical Placement:\*\* This intervention is applied specifically to \*\*two dental implants\*\* located in the maxillary esthetic zone
Also known as: Zirconia
Margina Bone Loss
Method: The marginal bone height level is radiographically assessed using Digital Subtraction Radiography with the DIGORA system. Technique: Researchers utilize a long paralleling technique to measure bone height in millimeters from the mesial and distal aspects of the implants. Standardization: To ensure consistency across different time points, a customized occlusal bite index (made of hard acrylic attached to a film holder) is used to standardize the film placement and the angle of the X-ray cone.
Time frame: the assessments are conducted at the following intervals: Baseline (T0): Immediately after the placement of the implants. 6 Months (T4): Six months after the initial implant placement. 12 Months (T5): One year after the initial implant placement
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Plan to share: Undecided — Confidentiality and Privacy**: All participant information is kept in safekeeping to protect their identity. Records containing names or personal identifiers are stored separately from the study records and are identified only by code numbers to maintain anonymity. Restricted Access to Personnel**: Access to the full, unblinded datasets is limited to the principal investigator and the study supervisors. Other project team members only receive data that has been blinded to any identifying information. Security Measures**: Data is stored on a personal laptop and encrypted using password protection to prevent unauthorized access. Physical records are kept in locked file cabinets. Institutional and Academic Requirements: The data is primarily collected for a master's degree thesis at Cairo University. Thedissemination policy requires the trial to be described in a thesis form and approved by the department before it can be published internationally Ethical Constraints
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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