Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Biological complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
PEEK-RPDs
Participants with removable partial dentures made of PEEK
Intervention: Removable Partial Denture (Device)
Outcomes
Primary Outcomes
Biological complications
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Thomas Stober
Prof. Dr.
University Hospital Heidelberg