Prosthesis Survival
Conditions
Keywords
prosthesis, dental implants, PEEK
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.
Interventions
DEVICEProsthetic single-tooth prosthesis using PEEK
A single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis.
Sponsors
Invibio Ltd
Malo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the prosthesis | one year | Evaluation of the survival for the implant-supported crowns; nominal (survival,failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Survival of the implants | one year | Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) |
| 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 |
| Denture anatomic form | one year | Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability. |
Countries
Portugal
Outcome results
None listed