The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 Hybrid concept (standard and zygomatic implants) after one year of follow-up. The main question it aims to answer is: \- What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.
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 full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional 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 after 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.
Malo Clinic
Lisbon, Portugal
Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time frame: one year
Survival of the implants
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time frame: one year
Incidence of biological complications
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Time frame: one year
Incidence of mechanical complications
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Time frame: one year
Marginal bone resorption (standard implants)
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Time frame: one year
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Denture staining
Veneer staining; 0:heavily stained; 10: no stains
Time frame: one year
Color stability
Color stability; 0: heavy discoloration; 10: no discoloration
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Masking
NONE
Enrollment
10
Time frame: one year
Anatomic form
Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
Time frame: one year
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Aesthetics
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Overall Chewing ability
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time frame: one year
Oral Health Impact Profile
Oral Health Impact Profile OHIP-14 questionnaire
Time frame: One year
Laboratory preparation time
Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.
Time frame: one year
Clinical operative time
Average operative time to load the final prosthesis
Time frame: one year