Prosthesis SurvivalPEEKPilotSTNCT05589532
Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.
A study testing Prosthetic single-tooth prosthesis using PEEK in people with Prosthesis Survival, run by Malo Clinic at 1 site in Portugal.
Trial summary
The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is: What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The… 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?
- Prosthetic single-tooth prosthesis using PEEK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Aug 2020to 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
- Patients rehabilitated with a single crown supported by and implant in immediate function;
- 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 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Single Teeth Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic Single Crowns Supported by Dental Implants
The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.
Read the detailed description
Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using Single Crowns. 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 fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including staining, colour stability and anatomical form; patient in mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs for economical purposes.
- Conditions
- Prosthesis Survival
- Being tested
- Prosthetic single-tooth prosthesis using PEEK
- Keywords
- prosthesis, dental implants, 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.
Prosthetic single-tooth prosthesis using PEEKDevice
Also called PEEK prosthesis
A single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic single-tooth prosthesis using PEEK | Experimental | An implant-supported single tooth prosthesis using a PEEK polymer in its composition Receives: Device: Prosthetic single-tooth prosthesis using 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 implant-supported crowns; nominal (survival,failure)
Measured: one year
Secondary outcomes (12)
Survival of the implants
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Measured: one year
Incidence of biological complications
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Measured: one year
Incidence of mechanical complications
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Measured: one year
Marginal bone resorption
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Measured: one year
Denture staining
Veneer staining; 0:heavily stained; 10: no stains
Measured: one year
Denture colour stability
Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability
Measured: one year
Denture anatomic form
Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.
Measured: one year
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
ln mouth comfort
Patient in 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
Laboratory preparation time
Average laboratory time to produce the finished prosthesis, the active technician time spent in Computer assisted design, Computer assisted manufacture, mill and veneering.
Measured: one year
Clinical operative time
Average operative time to load the final prosthesis
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 start6 Aug 2020
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Invibio Ltd decided to leave the market and stop PEEK 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
- 9 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
- NCT05589532
- Sponsor's protocol ID
- PEEKPilotST
- Acronym
- PEEKPilotST
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2022
- Last updated
- 26 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Single Teeth Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic Single Crowns Supported by Dental Implants
- ClinicalTrials.gov ID
- NCT05589532
- Acronym / sponsor ID
- PEEKPilotST / PEEKPilotST
- Conditions
- Prosthesis Survival
- Keywords
- prosthesis, dental implants, PEEK
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Invibio Ltd decided to leave the market and stop PEEK production
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Malo ClinicUniversity, hospital or other
- Collaborators
- Invibio Ltd
- Study start
- 6 Aug 2020 (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 study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.
Detailed description
Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using Single Crowns. 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 fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including staining, colour stability and anatomical form; patient in mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs for economical purposes.
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 |
|---|---|---|
| Prosthetic single-tooth prosthesis using PEEK | Experimental | Device: Prosthetic single-tooth prosthesis using PEEKAn implant-supported single tooth prosthesis using a PEEK polymer in its composition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients rehabilitated with a single crown supported by and implant in immediate function;
- 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.
Key exclusion criteria (4 listed)
- Female Subjects who are pregnant;
- 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 |
|---|---|---|
| Prosthetic single-tooth prosthesis using PEEKAlso: PEEK prosthesisA single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis. | Device | Prosthetic single-tooth prosthesis using PEEK |
Primary outcome
Survival of the prosthesis
Time frame: one year
Evaluation of the survival for the implant-supported crowns; nominal (survival,failure)
12 secondary outcomes
Survival of the implants
Time frame: one year
Incidence of biological complications
Time frame: one year
Incidence of mechanical complications
Time frame: one year
Marginal bone resorption
Time frame: one year
Denture staining
Time frame: one year
Denture colour stability
Time frame: one year
Denture anatomic form
Time frame: one year
Patient tissue reaction
Time frame: one year
ln mouth comfort
Time frame: one year
Oral Health Impact Profile OHIP-14
Time frame: one year
Laboratory preparation time
Time frame: one year
Clinical operative time
Time frame: one year
Results and safety
The study was stopped early (reason given: Invibio Ltd decided to leave the market and stop PEEK production). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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 Prosthetic single-tooth prosthesis using 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 3 inclusion and 4 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 26 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 decided to leave the market and stop PEEK 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 26 Aug 2025.