PEEKPilotSB: Partial Implant-supported Rehabilitation Using PEEK
Study Details
Study Description
Brief Summary
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone
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used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
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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.
| 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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Partial rehabilitation using PEEK 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Survival of the prosthesis [one year]
Evaluation of the survival for the 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 [one year]
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
- Denture staining [one year]
Veneer staining; 0:heavily stained; 10: no stains
- Denture colour stability [one year]
Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability
- Denture anatomic form [one year]
Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.
- Patient tissue reaction [one year]
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- ln mouth comfort [one year]
Patient in mouth comfort. Visual analogue scale (0-10 cm); 0:very poor; 10: very good
- Oral Health Impact Profile OHIP-14 [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 Computer assisted design, Computer assisted manufacture, 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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Patients rehabilitated with dental implants and a 3 unit Bridge where the molars are missing in one jaw, with at least both canines present;
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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 who are currently enrolled in a clinical study;
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Subjects requiring or currently having ongoing orthodontic treatment.
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.- PEEKPilotSB