An interventional study of Partial rehabilitation using PEEK in Prosthesis Survival, sponsored by Malo Clinic. Terminated at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Malo Clinic · Not applicable, Interventional, and Treatment
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of partial implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with dental implants will receive a definitive 3 unit prosthesis incorporating Poly-ether-ehter-ketone.
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 3 Unit fixed prostheses supported by dental 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 at 4 to 8 weeks, 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 denture staining, colour stability and anatomic form; patients' 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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's enrollment of 5 is below the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Malo Clinic is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 3-unit implant-supported fixed prosthesis using PEEK polymer in its composition for the rehabilitation of the partial edentulous.
Device: Partial rehabilitation using PEEK
A 3-unit implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis for partial rehabilitation of edentulous jaws.
Also known as: PEEK prosthesis
Survival of the prosthesis
Evaluation of the survival for the implant-supported prosthesis; nominal (survival,failure)
Time frame: one year
Survival of the implants
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time frame: one year
Incidence of biological complications
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Time frame: one year
Incidence of mechanical complications
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Time frame: 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
Time frame: one year
Denture staining
Veneer staining; 0:heavily stained; 10: no stains
Time frame: one year
Denture colour stability
Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability
Time frame: one year
Denture anatomic form
Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.
Time frame: one year
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
ln mouth comfort
Patient in mouth comfort. Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Oral Health Impact Profile OHIP-14
Oral Health Impact Profile OHIP-14 questionnaire
Time frame: 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.
Time frame: one year
Clinical operative time
Average operative time to load the final prosthesis
Time frame: one year
Plan to share: Yes — Anonymized database containing the study variables
Supporting information: Statistical analysis plan
Time frame: Upon study completion and for 8 years.
Access criteria: Upon solicitation to the Investigators
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Mar 2025, 29 months.
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This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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