PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.

Not Applicable

• Conditions: Prosthesis Survival
• Interventions: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

• Registration Number: NCT05589545
• Lead Sponsor: Malo Clinic

Brief Summary

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.

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 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 Timeline

• Study Start: 2019-07-19
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-21
• Last Update Posted: 2022-10-24
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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 with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects who are currently enrolled in a clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis	Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Primary Outcome Measures

Name	Time	Method
Survival of the prosthesis	one year	Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

Secondary Outcome Measures

Name	Time	Method
Overall Chewing ability	one year	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Marginal bone resorption (standard implants)	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
Laboratory preparation time	one year	Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.
Incidence of mechanical complications	one year	Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Oral Health Impact Profile	One year	Oral Health Impact Profile OHIP-14 questionnaire
Survival of the implants	one year	Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Anatomic form	one year	Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
Patient tissue reaction	one year	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Color stability	one year	Color stability; 0: heavy discoloration; 10: no discoloration
ln mouth comfort	one year	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Incidence of biological complications	one year	Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Aesthetics	one year	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Clinical operative time	one year	Average operative time to load the final prosthesis

Trial Locations

Locations (1)

Malo Clinic; 🇵🇹 Lisbon, Portugal