AO4PEEKRG: Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: All-on-4 PEEK routine Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis |
Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Survival of the prosthesis [5 years]
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Secondary Outcome Measures
- Survival of the implants [5 years]
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
- Incidence of biological complications [5 years]
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
- Incidence of mechanical complications [5 years]
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
- Marginal bone resorption [5 years]
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
- Denture staining [5 years]
Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains
- In mouth comfort [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Overall chewing feeling [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Oral Health Impact Profile OHIP-14 [5 years]
Likert Scale (0=least impact/never, 4=highest impact/very often)
- Patient tissue reaction [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Framework integrity [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Veneer adhesion [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Manufacture issues [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Handling of material compared to metal [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Aesthetics [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Speech [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Fit [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Hygiene around the implants [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Hygiene - how much plaque/calculus adheres to the prosthesis [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Overall classification from KOL [5 years]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Malo Clinic | Lisbon | Portugal | 1600-042 |
Sponsors and Collaborators
- Malo Clinic
- Invibio Ltd
Investigators
- Principal Investigator: Miguel A de Araújo Nobre, PhD, Director of Research, Development and Education
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AO4PEEKRoutGroup