Removable Partial Dentures Made of PEEK

N/ARecruitingNCT06191107

University Hospital Heidelberg50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tooth Loss

Interventions

Removable Partial DentureDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Heidelberg, Department of Prosthodontics

Heidelberg, Germany

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Thomas Stober, Assoc. Prof.

CONTACT

004962215636048 thomas.stober@med.uni-heidelberg.de

Bohn Eva-Marie, Assis. Prof.

CONTACT

004962215638665 eva-marie.bohn@med.uni-heidelberg.de

Data from ClinicalTrials.gov

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