Rehabilitation of Single Teeth Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic Single Crowns Supported by Dental Implants
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prosthesis Survival
- Sponsor
- Malo Clinic
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Survival of the prosthesis
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
Brief Summary
The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive 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 Single Crowns. 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 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 staining, colour stability and anatomical form; patient 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 for economical purposes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients rehabilitated with a single crown supported by and implant in immediate function;
- •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 crowns; nominal (survival,failure)
Secondary Outcomes
- 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)
- 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)