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| Name | Class |
|---|---|
| Invibio Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | 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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the prosthesis | Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) | one year |
| 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) | one year |
| Incidence of biological complications |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| one year |
| Incidence of mechanical complications | Loosening or fracture of prosthetic components; Nominal (no incidence, incidence) | 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 | one year |
| Patient tissue reaction | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year |
| Denture staining | Veneer staining; 0:heavily stained; 10: no stains | one year |
| Color stability | Color stability; 0: heavy discoloration; 10: no discoloration | one year |
| Anatomic form | Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form | one year |
| ln mouth comfort | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year |
| Aesthetics | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year |
| Overall Chewing ability | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year |
| Oral Health Impact Profile | Oral Health Impact Profile OHIP-14 questionnaire | 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. | one year |
| Clinical operative time | Average operative time to load the final prosthesis | one year |