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NCT Number: NCT06191107

Removable Partial Dentures 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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg, Department of Prosthodontics

Heidelberg, 69126, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removable Partial Denture

Device

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

Primary outcomes

  1. 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.

  2. 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. 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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Medical University Innsbruck
  • Merz Dental GmbH

Registry information

Official study title

Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK

Acronym: KLAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 5, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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