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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05589545
Other study ID # PEEKPilotZyg
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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