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

Prosthesis Survival Clinical Trial

— PEEKPilotZyg  

Official title:

Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05589545
• Other study ID #: PEEKPilotZyg
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: February 2024

Study information

• Verified date: October 2022
• Source: Malo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

Device:
• Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
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.

Locations

Country	Name	City	State
Portugal	Malo Clinic	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
Malo Clinic	Invibio Ltd

Country where clinical trial is conducted

Portugal, 

Outcome

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