- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06191107
Removable Partial Dentures Made of PEEK (KLAP)
December 19, 2023 updated by: Thomas Stober, University Hospital Heidelberg
Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK
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 Overview
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Stober, Assoc. Prof.
- Phone Number: 004962215636048
- Email: thomas.stober@med.uni-heidelberg.de
Study Contact Backup
- Name: Bohn Eva-Marie, Assis. Prof.
- Phone Number: 004962215638665
- Email: eva-marie.bohn@med.uni-heidelberg.de
Study Locations
-
-
-
Heidelberg, Germany, 69126
- Recruiting
- University Hospital Heidelberg, Department of Prosthodontics
-
Contact:
- Thomas Stober, Assoc. Prof.
- Phone Number: 004962215636048
- Email: thomas.stober@med.uni-heidelberg.de
-
Contact:
- Bohn Eva-Marie, Assis. Prof.
- Phone Number: 004962215638665
- Email: eva-marie.bohn@med.uni-heidelberg.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEEK-RPDs
Participants with removable partial dentures made of PEEK
|
Integration of removable partial dentures made of PEEK for the treatment of tooth loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
3 years
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Peter Rammelsberg, Prof. / Head, University Hospital Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2028
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
December 19, 2023
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMA-ID 15379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tooth Loss
-
Institut Straumann AGCompleted
-
University of AarhusCompleted
-
Duygu KarasanHacettepe UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Cairo UniversityNot yet recruitingLoss of Teeth Due to ExtractionEgypt
-
Eisenhower Army Medical CenterUnknownLoss of Teeth Due to ExtractionUnited States
-
The University of Texas Health Science Center at...Osteogenics BiomedicalCompletedLoss of Teeth Due to Extraction
-
Institut Straumann AGTerminated
-
Heidelberg UniversityCompletedTooth Loss, Teeth Replaced Using All Ceramic FPDsGermany
-
Inesa AstramskaitėCompletedAnxiety | Fear | Teeth, Impacted | Tooth-lossLithuania
Clinical Trials on Removable Partial Denture
-
Mansoura UniversityEnrolling by invitationDental Prosthesis ComplicationEgypt
-
National Dental Centre, SingaporeNational Medical Research Council (NMRC), SingaporeRecruitingPartial-edentulismSingapore
-
Faleh Tamimi3DRPD Inc.CompletedPartially Edentulous JawsCanada
-
Mansoura UniversityRecruiting
-
Cairo UniversityNot yet recruiting
-
Malo ClinicInvibio LtdEnrolling by invitationProsthesis SurvivalPortugal
-
Cairo UniversityRecruitingPartial-edentulism | Oral Health Related Quality of Life | 3D Printing | Temporary Partial DentureEgypt
-
Ain Shams UniversityRecruitingDental Implants | Implant | Partial Edentulism Class IIEgypt
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Cairo UniversityUnknown