TerminatedNot Applicable

Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture

Stopped: Invibio Ltd, producer of the PEEK material decided to leave the market and stop production.

Portugal10 participantsStarted 2019-12-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival of the prosthesis

Timeframe: one year

Trial details

NCT IDNCT05589506

SponsorMalo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Prosthesis Survival trials