Prosthesis SurvivalAO4PEEKRGNCT05589493
Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
A study testing Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis 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 prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years 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?
- Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Nov 2017to Jul 2026
- 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 immediate function implants for complete edentulous arches through the All-on-4 Concept.
- Patients in need of definitive implant-supported restorations.
- Written informed consent from each patient to participate in the study.
Who cannot join
- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:
- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.
Read the detailed description
Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.
The study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.
- Conditions
- Prosthesis Survival
- Being tested
- Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
- Keywords
- prosthesis, PEEK, All-on-4, All-on-four, dental implants
- 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 full-arch rehabilitation using a PEEK-acrylic resin prosthesisDevice
Also called PEEK prosthesis
A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by dental implants following the All-on-4 Concept arrangement.
| Study group | Role | What they receive |
|---|---|---|
| All-on-4 PEEK routine | Experimental | Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis Receives: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis |
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 implant-supported prosthesis; nominal (survival,failure)
Measured: 5 years
Secondary outcomes (19)
Survival of the implants
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Measured: 5 years
Incidence of biological complications
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Measured: 5 years
Incidence of mechanical complications
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Measured: 5 years
Marginal bone resorption
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Measured: 5 years
Denture staining
Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains
Measured: 5 years
In mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Overall chewing feeling
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Oral Health Impact Profile OHIP-14
Likert Scale (0=least impact/never, 4=highest impact/very often)
Measured: 5 years
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Framework integrity
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Veneer adhesion
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Manufacture issues
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Handling of material compared to metal
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Aesthetics
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Speech
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Fit
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Hygiene around the implants
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Hygiene - how much plaque/calculus adheres to the prosthesis
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
Overall classification from KOL
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: 5 years
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 Nov 2017
- Primary completion1 Apr 2021
- Study completionJul 2026 (estimated)
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
- 39 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
- NCT05589493
- Sponsor's protocol ID
- AO4PEEKRoutGroup
- Acronym
- AO4PEEKRG
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 21 Oct 2022
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
- ClinicalTrials.gov ID
- NCT05589493
- Acronym / sponsor ID
- AO4PEEKRG / AO4PEEKRoutGroup
- Conditions
- Prosthesis Survival
- Keywords
- prosthesis, PEEK, All-on-4, All-on-four, dental implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Malo ClinicUniversity, hospital or other
- Collaborators
- Invibio Ltd
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- Jul 2026 (estimated)
- 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 prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:
- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.
Detailed description
Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.
The study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.
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 |
|---|---|---|
| All-on-4 PEEK routine | Experimental | Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesisProsthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis |
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 immediate function implants for complete edentulous arches through the All-on-4 Concept.
- Patients in need of definitive implant-supported restorations.
- Written informed consent from each patient to participate in the study.
Key exclusion criteria (1 listed)
- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
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 full-arch rehabilitation using a PEEK-acrylic resin prosthesisAlso: PEEK prosthesisA prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by dental implants following the All-on-4 Concept arrangement. | Device | All-on-4 PEEK routine |
Primary outcome
Survival of the prosthesis
Time frame: 5 years
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
19 secondary outcomes
Survival of the implants
Time frame: 5 years
Incidence of biological complications
Time frame: 5 years
Incidence of mechanical complications
Time frame: 5 years
Marginal bone resorption
Time frame: 5 years
Denture staining
Time frame: 5 years
In mouth comfort
Time frame: 5 years
Overall chewing feeling
Time frame: 5 years
Oral Health Impact Profile OHIP-14
Time frame: 5 years
Patient tissue reaction
Time frame: 5 years
Framework integrity
Time frame: 5 years
Veneer adhesion
Time frame: 5 years
Manufacture issues
Time frame: 5 years
Handling of material compared to metal
Time frame: 5 years
Aesthetics
Time frame: 5 years
Speech
Time frame: 5 years
Fit
Time frame: 5 years
Hygiene around the implants
Time frame: 5 years
Hygiene - how much plaque/calculus adheres to the prosthesis
Time frame: 5 years
Overall classification from KOL
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- 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 full-arch rehabilitation using a PEEK-acrylic resin prosthesis 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 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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?
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: 5 years). 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 Oct 2022.