Health TrialsbyHealthPanel

Removable Partial Dentures Made of PEEK

ConditionTooth Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital Heidelberg

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Indication for a clasp-anchored removable partial denture

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Removable Partial Denture

    Device

    Integration of removable partial dentures made of PEEK for the treatment of tooth loss.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PEEK-RPDsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 years
3

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.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Medical University Innsbruck

Collaborator

Merz Dental GmbH

Collaborator

Source ClinicalTrials.gov
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