NCT06191107

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Feb 2024Nov 2028

First Submitted

Initial submission to the registry

November 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

November 28, 2023

Last Update Submit

May 10, 2024

Conditions

Tooth Loss

Keywords

Removable Partial DenturePolyetheretherketoneOral Health Related Quality of Life

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 years

Study Arms (1)

PEEK-RPDs

EXPERIMENTAL

Participants with removable partial dentures made of PEEK

Device: Removable Partial Denture

Interventions

Removable Partial DentureDEVICE

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

PEEK-RPDs

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for a clasp-anchored removable partial denture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg, Department of Prosthodontics

Heidelberg, 69126, Germany

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Interventions

Denture, Partial, Removable

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Denture, PartialDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Peter Rammelsberg, Prof. / Head

    University Hospital Heidelberg

    STUDY CHAIR

Central Study Contacts

Thomas Stober, Assoc. Prof.

CONTACT

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

Bohn Eva-Marie, Assis. Prof.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 28, 2023

First Posted

January 5, 2024

Study Start

February 12, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)