Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture

NCT ID: NCT05589506

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin removable partial denture used in partial edentulous rehabilitation after one year of follow-up. The main question it aims to answer is:

• What is the survival outcome of partial rehabilitations using Poly-ether-ether-ketone-acrylic resin removable partial dentures? The participants will receive a definitive removable partial denture incorporating Poly-ether-ehter-ketone.

Detailed Description

Folowing the recent applications of polyetheretherketone (PEEK) material in Dentistry it is necessary to further extend the evaluation to the use of Removable Partial Denture (RPD) rehabilitations. To test this, the study design to be used will be a single-centre, prospective observational cohort study to evaluate the short term outcome of the Removal Partial Denture (RPO) supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated at baseline, RPD design, dental fitting, follow-up assessment at 4 weeks, 6 and 12 months after dental loading regarding: JUVORA prosthetic survival including repair and relining, assessment of the adaptation of the RPD frame, adaptation of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetics assessment (staining, color stability, anatomic form), oral health assessment of the RPD abutment teeth periodontium (plaque index, gingival index, probing pocket depths, bleeding on probing, mobility) incidence of mechanical complications (loosening or fracture of prosthetic components), patient assessment of RPD comfort, aesthetics and chewing ability; assessment of RPD preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

Conditions

Prosthesis Survival

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Removable partial denture PEEK

Removable partial denture using PEEK-acrylic resin

Group Type: EXPERIMENTAL

Removable partial denture PEEK

Intervention Type: DEVICE

A removable partial denture incorporating PEEK and acrylic resin in its composition used as definitive prosthesis to rehabilitate partial edentulism in the maxilla or mandible.

Interventions

Removable partial denture PEEK

A removable partial denture incorporating PEEK and acrylic resin in its composition used as definitive prosthesis to rehabilitate partial edentulism in the maxilla or mandible.

Intervention Type: DEVICE

Other Intervention Names

PEEK prosthesis

Eligibility Criteria

Inclusion Criteria

• partial edentulism with at least a posterior natural tooth occlusaI stop (molar or premolar), defined as Kennedy's Class I, Class lI or Class lII,
• occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest;
• previous denture wearing experience,
• stable oral health in terms of absence of disease activity affecting the periodontium, caries, pulp and the structural/aesthetic integrity of restored teeth.
• Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion Criteria

• Female Subjects who are pregnant;
• Subjects requiring extensive treatment prior to the provision of a removable partial denture;
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;
• Subjects who are currently enrolled in a clinical study;
• Subjects requiring or currently having ongoing orthodontic treatment;
• Subjects with an opposing Removable Partial Denture (RPD).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Invibio Ltd

INDUSTRY

Sponsor Role: collaborator

Malo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel A de Araújo Nobre, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Research, Development and Education

Locations

Malo Clinic

Lisbon, Lisbon District, Portugal

Countries

Portugal

Other Identifiers

PEEKPilotRPD

Identifier Type: -

Identifier Source: org_study_id