Prosthesis SurvivalPEEKPilotRPDNCT05589506
Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture
A study testing Removable partial denture PEEK in people with Prosthesis Survival, run by Malo Clinic at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- Removable partial denture PEEK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Dec 2019to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)
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.
Read the 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
- Being tested
- Removable partial denture PEEK
- Keywords
- prosthesis, removable partial denture, PEEK
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable partial denture PEEKDevice
Also called PEEK prosthesis
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.
| Study group | Role | What they receive |
|---|---|---|
| Removable partial denture PEEK | Experimental | Removable partial denture using PEEK-acrylic resin Receives: Device: Removable partial denture PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)
Measured: one year
Secondary outcomes (14)
Assessment of the adaptation of the RPD frame
Nominal: 0: adapted; 1: not adapted
Measured: one year
Function of RPD is excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: one year
Aesthetics of RPD are excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: one year
Staining of RPD is absent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: one year
Color stability is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: one year
Anatomic form of RPD is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: one year
Incidence of mechanical complications
Loosening or fracture of prosthetic components Nominal: O: absence; 1: presence
Measured: one year
Incidence of biological complications
Presence of periodontal pathology Nominal: O: absence; 1: presence
Measured: one year
Plaque accumulation around RPD abutment teeth.
Simplified Oral Hygiene Index (Greene and Vermelion, 1964). Ordinal: 0: no debris or stain present; 1: Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered; 2: Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface; 3: Soft debris covering more than two thirds of the exposed tooth surface.
Measured: one year
Bleeding around RPO abutment teeth
Gingival index (Loe and Silness 1963)'. Ordinal: 0: absence of inflammation/normal gingiva; 1: mild inflammation, slight change in color, slight edema, no bleeding on probing; 2: moderate inflammation, moderate glazing, redness, edema and hypertrophy, bleeding on probing; 3: severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Measured: one year
Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters
Measured through probing with a periodontal probe, evaluated on all tooth aspects. Scale: Distance between mucosal margin and probe stop measured in millimeters.
Measured: one year
Mobility of RPO abutment teeth
Mobility classification (Miller 1950). Ordinal: 0: no detected mobility; 1: first sign of movement greater than normal; 2: up to 1 mm in any direction; 3: more than 1 mm in any direction and/or vertical depression.
Measured: one year
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
Oral Health Impact Profile OHIP-14
Oral Health Impact Profile OHIP-14 questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start13 Dec 2019
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Invibio Ltd, producer of the PEEK material decided to leave the market and stop production.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Invibio Ltd
- Responsible party
- Sponsor
- Investigators
- Miguel A de Araújo Nobre, PhD, Principal investigator, Director of Research, Development and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589506
- Sponsor's protocol ID
- PEEKPilotRPD
- Acronym
- PEEKPilotRPD
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2022
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized database containing the study variables
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)
- ClinicalTrials.gov ID
- NCT05589506
- Acronym / sponsor ID
- PEEKPilotRPD / PEEKPilotRPD
- Conditions
- Prosthesis Survival
- Keywords
- prosthesis, removable partial denture, PEEK
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Invibio Ltd, producer of the PEEK material decided to leave the market and stop production.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Malo ClinicUniversity, hospital or other
- Collaborators
- Invibio Ltd
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Removable partial denture PEEK | Experimental | Device: Removable partial denture PEEKRemovable partial denture using PEEK-acrylic resin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removable partial denture PEEKAlso: PEEK prosthesisA removable partial denture incorporating PEEK and acrylic resin in its composition used as definitive prosthesis to rehabilitate partial edentulism in the maxilla or mandible. | Device | Removable partial denture PEEK |
Primary outcome
Survival of the prosthesis
Time frame: one year
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)
14 secondary outcomes
Assessment of the adaptation of the RPD frame
Time frame: one year
Function of RPD is excellent
Time frame: one year
Aesthetics of RPD are excellent
Time frame: one year
Staining of RPD is absent
Time frame: one year
Color stability is maintained
Time frame: one year
Anatomic form of RPD is maintained
Time frame: one year
Incidence of mechanical complications
Time frame: one year
Incidence of biological complications
Time frame: one year
Plaque accumulation around RPD abutment teeth.
Time frame: one year
Bleeding around RPO abutment teeth
Time frame: one year
Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters
Time frame: one year
Mobility of RPO abutment teeth
Time frame: one year
ln mouth comfort
Time frame: one year
Oral Health Impact Profile OHIP-14
Time frame: one year
Results and safety
The study was stopped early (reason given: Invibio Ltd, producer of the PEEK material decided to leave the market and stop production.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Yes. Anonymized database containing the study variables
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A de Araújo Nobre, PhD principal investigator
Director of Research, Development and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable partial denture PEEK in people with Prosthesis Survival, run by Malo Clinic at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Invibio Ltd, producer of the PEEK material decided to leave the market and stop production.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the prosthesis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.