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

NCT07708558 | Completed

• 1 other identifier: PROS-PEEK-2025-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial Edentulism; Partial Edentulism Class 1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BioHPP Clasps Opposing Natural Tooth Abutments

EXPERIMENTAL

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 Clasps Opposing Zirconia Abutmen

EXPERIMENTAL

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

Interventions

PEEK Removable Partial Denture Framework with Natural Tooth Abutments DEVICE

BioHPP Removable Partial Denture Framework with Natural Tooth Abutments

BioHPP Clasps Opposing Natural Tooth Abutments

PEEK Removable Partial Denture Framework with Zirconia Abutments DEVICE

BioHPP Removable Partial Denture Framework with Zirconia Abutments

BioHPP Clasps Opposing Zirconia Abutmen

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry Mansoura university

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 16, 2026

Record last verified: 2023-06

Locations

EG (1)