PEEKPilotZyg: PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.
Study Details
Study Description
Brief 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. 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 |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Survival of the prosthesis [one year]
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Secondary Outcome Measures
- Survival of the implants [one year]
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
- Incidence of biological complications [one year]
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
- Incidence of mechanical complications [one year]
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
- Marginal bone resorption (standard implants) [one year]
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
- Patient tissue reaction [one year]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Denture staining [one year]
Veneer staining; 0:heavily stained; 10: no stains
- Color stability [one year]
Color stability; 0: heavy discoloration; 10: no discoloration
- Anatomic form [one year]
Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
- ln mouth comfort [one year]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Aesthetics [one year]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Overall Chewing ability [one year]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Oral Health Impact Profile [One year]
Oral Health Impact Profile OHIP-14 questionnaire
- Laboratory preparation time [one year]
Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.
- Clinical operative time [one year]
Average operative time to load the final prosthesis
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
Exclusion Criteria:
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Female Subjects who are pregnant.
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Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes.
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Subjects with any condition that would compromise their participation and follow-up in this clinical study.
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Subjects who are currently enrolled in a clinical study.
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.- PEEKPilotZyg