Surface Wear of PEEK Clasp Against Zirconia Full-Coverage Restored Abutments in Distal Extension Removable Partial Dentures (PEEKWear)

Clinical Evaluation of Surface Wear of PEEK Clasps Against Zirconia Full-Coverage Restored Abutments in Distal Extension Removable Partial Dentures

This prospective clinical comparative study will evaluate the surface wear of BioHPP (modified polyetheretherketone) clasps opposing either natural tooth abutments or zirconia full-coverage abutments in mandibular bilateral distal extension removable partial dentures. Ten participants will be randomly assigned to two equal groups. Surface topography changes of the clasp fitting surfaces will be assessed using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months. The findings will help determine the influence of abutment material on the wear behavior of BioHPP clasps and provide evidence for selecting appropriate abutment materials in removable partial denture treatment.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Partial Edentulism Class 1
• Intervention / Treatment: Device: PEEK Removable Partial Denture Framework with Natural Tooth Abutments; Device: PEEK Removable Partial Denture Framework with Zirconia Abutments

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • Faculty of dentistry Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adults aged 40-50 years. Mandibular Kennedy Class I partial edentulism. Bilateral distal extension edentulous areas. Presence of healthy canines and first premolars suitable as abutment teeth. Adequate oral hygiene and healthy periodontal condition. Adequate interarch space for removable partial denture fabrication. Ability and willingness to attend all scheduled follow-up visits and provide written informed consent.

Exclusion Criteria:

Systemic diseases or medications that could affect bone or soft tissue healing. Active periodontal disease or poor oral hygiene. Severe parafunctional habits (e.g., bruxism or clenching). Smoking. Pregnancy or lactation. Allergy or hypersensitivity to any study materials. Inability to comply with study procedures or follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioHPP Clasps Opposing Natural Tooth Abutments; Participants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging natural tooth abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear.	Device: PEEK Removable Partial Denture Framework with Natural Tooth Abutments; BioHPP Removable Partial Denture Framework with Natural Tooth Abutments
Experimental: BioHPP Clasps Opposing Zirconia Abutmen; Participants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging zirconia full-coverage abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear.	Device: PEEK Removable Partial Denture Framework with Zirconia Abutments; BioHPP Removable Partial Denture Framework with Zirconia Abutments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface topography changes of BioHPP clasp fitting surfaces	Surface wear of BioHPP clasp fitting surfaces assessed by scanning electron microscopy (SEM) and digital morphometric analysis	Baseline (denture insertion), 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PROS-PEEK-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No