Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture

NCT05589506 | Terminated

• 1 other identifier: PEEKPilotRPD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis Survival

Keywords

prosthesis; removable partial denture; PEEK

Outcome Measures

Primary Outcomes (1)

• Survival of the prosthesis

  Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)

  one year

Secondary Outcomes (14)

• Assessment of the adaptation of the RPD frame

  one year

• Function of RPD is excellent

  one year

• Aesthetics of RPD are excellent

  one year

• Staining of RPD is absent

  one year

• Color stability is maintained

  one year

Study Arms (1)

Removable partial denture PEEK

EXPERIMENTAL

Removable partial denture using PEEK-acrylic resin

Device: Removable partial denture PEEK

Interventions

Removable partial denture PEEK 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.

Also known as: PEEK prosthesis

Removable partial denture PEEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Malo Clinic: lead
• Invibio Ltd: collaborator

Study Sites (1)

Malo Clinic

Lisbon, Lisbon District, 1600-042, Portugal

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel A de Araújo Nobre, PhD

  Director of Research, Development and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: December 13, 2019
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Upon study completion and for 8 years.
• Access Criteria: Upon solicitation to the Investigators

Locations

PT (1)