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| Name | Class |
|---|---|
| Invibio Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-on-4 PEEK routine | Experimental | Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the prosthesis | Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the implants | Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) | 5 years |
| Incidence of biological complications |
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Inclusion Criteria:
Exclusion Criteria:
- Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A de Araújo Nobre, PhD | Director of Research, Development and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malo Clinic | Lisbon | 1600-042 | Portugal |
Anonymized database containing the study variables
Upon study completion and for 8 years.
Upon solicitation to the Investigators
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective cohort study
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Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
| 5 years |
| Incidence of mechanical complications | Loosening or fracture of prosthetic components; Nominal (no incidence, incidence) | 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 | 5 years |
| Denture staining | Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains | 5 years |
| In mouth comfort | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Overall chewing feeling | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Oral Health Impact Profile OHIP-14 | Likert Scale (0=least impact/never, 4=highest impact/very often) | 5 years |
| Patient tissue reaction | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Framework integrity | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Veneer adhesion | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Manufacture issues | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Handling of material compared to metal | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Aesthetics | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Speech | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Fit | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Hygiene around the implants | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Hygiene - how much plaque/calculus adheres to the prosthesis | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |
| Overall classification from KOL | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | 5 years |