Removable Partial Dentures Made of PEEK

Not Applicable

Recruiting

• Conditions: Tooth Loss
• Interventions: Device: Removable Partial Denture

• Registration Number: NCT06191107
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

As part of the clinical study, 25 patients each were provided with removable partial dentures with clasps made of PEEK in two centres (University Hospital Heidelberg, Department of Prosthodontics and University Hospital for Dental Prosthetics Innsbruck). The patients were examined over a period of 3 years for the number and type of technical or biological complications and questioned about their oral health-related quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Study Start: 2024-02-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2026-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Indication for a clasp-anchored removable partial denture

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Exclusion Criteria

• Minors and adults unable to give consent
• Pregnancy or breastfeeding
• Severe general illnesses
• Allergies or other intolerances to one of the materials used (PEEK, PMMA)
• Suspicion of lack of compliance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK-RPDs	Removable Partial Denture	Participants with removable partial dentures made of PEEK

Primary Outcome Measures

Name	Time	Method
Biological complications	3 years	Biological complications (intolerances, damage to the abutment teeth and/or the periodontium, survival of abutment teeth) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs.
Oral-Health-Related Quality of Life	3 months	Improvement of Oral-Health-Related Quality of Life (OHRQoL) after incorporation of removable partial dentures made of PEEK (PEEK-RPDs) by using a short version of the validated "Oral Health Impact Profile" questionnaire with 14 questions (OHIP-G 14). A precise evaluation is obtained by adding up the 14 items with their frequency ("never"=0, "hardly"=1, "now and then"=2, "often"=3 and "very often"=4) up to a total value. This value can range from 0 (no limitation of OHRQL) to 56 (severe limitation of OHRQoL). These data are collected before treatment and 3 months after insertion of the PEEK-RPDs.
Technical complications	3 years	Technical complications (clasp fractures, denture defects) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs.

Trial Locations

Locations (1)

University Hospital Heidelberg, Department of Prosthodontics; 🇩🇪 Heidelberg, Germany