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RecruitingNCT06191107KLAPUpdated May 13, 2024

Removable Partial Dentures Made of PEEK

An interventional study of Removable Partial Denture in Tooth Loss, sponsored by University Hospital Heidelberg. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Loss

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Keywords

  • Removable Partial Denture
  • Polyetheretherketone
  • Oral Health Related Quality of Life
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 50 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Indication for a clasp-anchored removable partial denture

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    PEEK-RPDs

    Participants with removable partial dentures made of PEEK

    Device: Removable Partial Denture

Interventions

  • DeviceRemovable Partial Denture

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06191107
Collaborators
Medical University Innsbruck, Merz Dental GmbH
Responsible party
Thomas Stober (Prof. Dr., University Hospital Heidelberg) — Principal investigator
First posted
Jan 5, 2024
Start date
Feb 12, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2028 (estimated)
Last update
May 13, 2024

Study contacts

Thomas Stober, Assoc. Prof.
Contact
thomas.stober@med.uni-heidelberg.de
004962215636048
Bohn Eva-Marie, Assis. Prof.
Contact
eva-marie.bohn@med.uni-heidelberg.de
004962215638665
Peter Rammelsberg, Prof. / Head
study chair · University Hospital Heidelberg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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