Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic 3' Unit Fixed Prosthesis Supported by Dental Implants.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prosthesis Survival
- Sponsor
- Malo Clinic
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Survival of the prosthesis
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
Brief Summary
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
- 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients rehabilitated with dental implants and a 3 unit Bridge where the molars are missing in one jaw, with at least both canines present;
- •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;
- •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
- •Female Subjects who are pregnant;
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;
- •Subjects who are currently enrolled in a clinical study;
- •Subjects requiring or currently having ongoing orthodontic treatment.
Outcomes
Primary Outcomes
Survival of the prosthesis
Time Frame: one year
Evaluation of the survival for the implant-supported prosthesis; nominal (survival,failure)
Secondary Outcomes
- Patient tissue reaction(one year)
- ln mouth comfort(one year)
- Oral Health Impact Profile OHIP-14(one year)
- Laboratory preparation time(one year)
- Clinical operative time(one year)
- Survival of the implants(one year)
- Incidence of biological complications(one year)
- Incidence of mechanical complications(one year)
- Marginal bone resorption(one year)
- Denture staining(one year)
- Denture colour stability(one year)
- Denture anatomic form(one year)