Removable Partial Dentures Made of PEEK

Tooth Loss Clinical Trial

— KLAP  

Official title:

Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191107
• Other study ID #: DMA-ID 15379
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: November 2028

Study information

• Verified date: May 2024
• Source: University Hospital Heidelberg
• Contact: Thomas Stober, Assoc. Prof.
• Phone: 004962215636048
• Email: thomas.stober[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2028
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Indication for a clasp-anchored removable partial denture

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Device:
• Removable Partial Denture
Integration of removable partial dentures made of PEEK for the treatment of tooth loss.

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg, Department of Prosthodontics	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Medical University Innsbruck, Merz Dental GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral-Health-Related Quality of Life	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.	3 months
Primary	Biological complications	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.	3 years
Primary	Technical complications	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.	3 years