Prosthesis Survival
Conditions
Keywords
prosthesis, dental implants, PEEK
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.
Interventions
DEVICEPartial 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.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the prosthesis | one year | Evaluation of the survival for the implant-supported prosthesis; 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