Comparative Assessment of Marginal Bone Loss Around the Implant When Using PEEK With Composite Veneering Versus Monolithic Zirconia Restorations as Implant Restorations

NCT07886008 | Completed DMC

• 1 other identifier: 6-2-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Partial Edentulism Class IV

Keywords

Marginal Bone Loss; Survival rate; Screw retained FPD; Zirconia; PEEK

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Marginal bone loss around Monolithic Zirconia screw-retained implant restoration

ACTIVE COMPARATOR

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

Marginal bone loss around PEEK screw-retained implant restoration veneered with composite

EXPERIMENTAL

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

Interventions

Monolithic zirconia screw-retained implant restoration PROCEDURE

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

Marginal bone loss around Monolithic Zirconia screw-retained implant restoration

PEEK (Polyetheretherketone) screw-retained implant restoration veneered with composite PROCEDURE

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

Marginal bone loss around PEEK screw-retained implant restoration veneered with composite

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Missing Teeth: Patients must be partially edentulous, specifically missing teeth in the upper (maxillary) aesthetic zone
• Age: between the ages of 20 and 50 years.
• Systemic Health: Individuals must be free from any systemic diseases
• Jaw Relationship: Participants must have an Angle's Class I skeletal relationship.
• Facial Structure: Patients must demonstrate normal facial symmetry

You may not qualify if:

• Jaw Joint Issues: Patients suffering from Temporomandibular Disorder (TMD) problems.
• Smoking Status: Heavy smokers are excluded from the study.
• Bone and Tissue Health: Patients with existing bone loss in the anterior (front) area, flabby tissues, or a sharp residual ridge.
• Neuromuscular Disorders: Any patient with a neuromuscular disorder is ineligible

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Giza Governorate, 11562, Egypt

Location

Related Publications (5)

• Moustafa Ali, R., Helmy, M. (2020). 'Poly ether-ether ketone veneered with composite Versus Porcelain fused to metal Full arch fixed screw retained prosthesis for atrophied mandibular ridges. One year randomized clinical and radiographic trial study', Egyptian Dental Journal, 66(Issue 4 - October (Fixed Prosthodontics, Removable Prosthodontics and Dental Materials)), pp. 2439-2449. doi: 10.21608/edj.2020.35663.1173

  BACKGROUND

• Reissmann DR, Dard M, Lamprecht R, Struppek J, Heydecke G. Oral health-related quality of life in subjects with implant-supported prostheses: A systematic review. J Dent. 2017 Oct;65:22-40. doi: 10.1016/j.jdent.2017.08.003. Epub 2017 Aug 5.

  PMID: 28789860 RESULT

• Martins RG, Castro TS, Dib LL, Gehrke SA, Mesquita AMM. Influence of Restorative Material on the Distribution of Loads to the Bone in Hybrid Abutment Crowns-In Vitro Study. Medicina (Kaunas). 2023 Jun 22;59(7):1188. doi: 10.3390/medicina59071188.

  PMID: 37512000 RESULT

• Yazigi C, Kern M, Chaar MS, Libecki W, Elsayed A. The influence of the restorative material on the mechanical behavior of screw-retained hybrid-abutment-crowns. J Mech Behav Biomed Mater. 2020 Nov;111:103988. doi: 10.1016/j.jmbbm.2020.103988. Epub 2020 Jul 26.

  PMID: 32799134 RESULT

• Belser UC, Mericske-Stern R, Bernard JP, Taylor TD. Prosthetic management of the partially dentate patient with fixed implant restorations. Clin Oral Implants Res. 2000;11 Suppl 1:126-45. doi: 10.1034/j.1600-0501.2000.011s1126.x.

  PMID: 11168262 RESULT

MeSH Terms

Interventions

polyetheretherketone; zirconium oxide

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Candidate, Department of Prosthodontics, Cairo university

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: October 21, 2026
• Study Start: April 10, 2025
• Primary Completion: August 10, 2026
• Study Completion: August 30, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

EG (1)