Prosthesis SurvivalPEEKPilotZygNCT05589545
PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.
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 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 Hybrid concept (standard and zygomatic implants) after one year of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Jul 2019to Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 with any condition that would compromise their participation and follow-up in this clinical study.
- Subjects who are currently enrolled in a clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.
The goal of this 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 Hybrid concept (standard and zygomatic implants) after one year 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 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 full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. 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 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.
- Conditions
- Prosthesis Survival
- Being tested
- Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
- Keywords
- prosthesis, dental implants, zygomatic 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 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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | 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: one year
Secondary outcomes (14)
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 (standard implants)
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Measured: one year
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
Denture staining
Veneer staining; 0:heavily stained; 10: no stains
Measured: one year
Color stability
Color stability; 0: heavy discoloration; 10: no discoloration
Measured: one year
Anatomic form
Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
Measured: one year
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
Aesthetics
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
Overall Chewing ability
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Measured: one year
Oral Health Impact Profile
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 CAD design, Cam 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 start19 Jul 2019
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (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
- 10 participants (estimated)
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
- NCT05589545
- Sponsor's protocol ID
- PEEKPilotZyg
- Acronym
- PEEKPilotZyg
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 24 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 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.
- ClinicalTrials.gov ID
- NCT05589545
- Acronym / sponsor ID
- PEEKPilotZyg / PEEKPilotZyg
- Conditions
- Prosthesis Survival
- Keywords
- prosthesis, dental implants, zygomatic implants, PEEK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Malo ClinicUniversity, hospital or other
- Collaborators
- Invibio Ltd
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (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 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 Hybrid concept (standard and zygomatic implants) after one year 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 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 full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. 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 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic 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 |
|---|---|---|
| Intervention | 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 with any condition that would compromise their participation and follow-up in this clinical study.
- Subjects who are currently enrolled in a clinical study.
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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept. | Device | Intervention |
Primary outcome
Survival of the prosthesis
Time frame: one year
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
14 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 (standard implants)
Time frame: one year
Patient tissue reaction
Time frame: one year
Denture staining
Time frame: one year
Color stability
Time frame: one year
Anatomic form
Time frame: one year
ln mouth comfort
Time frame: one year
Aesthetics
Time frame: one year
Overall Chewing ability
Time frame: one year
Oral Health Impact Profile
Time frame: One year
Laboratory preparation time
Time frame: one year
Clinical operative time
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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 2 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: status not confirmed, as of the sponsor's last update on 24 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: 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 24 Oct 2022.