PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation. (PEEKPilotZyg)
Primary Purpose
Prosthesis Survival
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Survival focused on measuring prosthesis, dental implants, zygomatic implants, PEEK
Eligibility Criteria
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.
Sites / Locations
- Malo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Outcomes
Primary Outcome Measures
Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Secondary Outcome Measures
Survival of the implants
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Incidence of biological complications
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Incidence of mechanical complications
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
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
Patient tissue reaction
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Denture staining
Veneer staining; 0:heavily stained; 10: no stains
Color stability
Color stability; 0: heavy discoloration; 10: no discoloration
Anatomic form
Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Aesthetics
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Overall Chewing ability
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Oral Health Impact Profile
Oral Health Impact Profile OHIP-14 questionnaire
Laboratory preparation time
Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.
Clinical operative time
Average operative time to load the final prosthesis
Full Information
NCT ID
NCT05589545
First Posted
October 18, 2022
Last Updated
October 20, 2022
Sponsor
Malo Clinic
Collaborators
Invibio Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05589545
Brief Title
PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malo Clinic
Collaborators
Invibio Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival
Keywords
prosthesis, dental implants, zygomatic implants, PEEK
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Intervention Type
Device
Intervention Name(s)
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Other Intervention Name(s)
PEEK prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival of the prosthesis
Description
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Survival of the implants
Description
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time Frame
one year
Title
Incidence of biological complications
Description
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Time Frame
one year
Title
Incidence of mechanical complications
Description
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Time Frame
one year
Title
Marginal bone resorption (standard implants)
Description
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Time Frame
one year
Title
Patient tissue reaction
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
one year
Title
Denture staining
Description
Veneer staining; 0:heavily stained; 10: no stains
Time Frame
one year
Title
Color stability
Description
Color stability; 0: heavy discoloration; 10: no discoloration
Time Frame
one year
Title
Anatomic form
Description
Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form
Time Frame
one year
Title
ln mouth comfort
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
one year
Title
Aesthetics
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
one year
Title
Overall Chewing ability
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
one year
Title
Oral Health Impact Profile
Description
Oral Health Impact Profile OHIP-14 questionnaire
Time Frame
One year
Title
Laboratory preparation time
Description
Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.
Time Frame
one year
Title
Clinical operative time
Description
Average operative time to load the final prosthesis
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel A de Araújo Nobre, PhD
Organizational Affiliation
Director of Research, Development and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malo Clinic
City
Lisbon
ZIP/Postal Code
1600-042
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized database containing the study variables
IPD Sharing Time Frame
Upon study completion and for 8 years.
IPD Sharing Access Criteria
Upon solicitation to the Investigators
Learn more about this trial
PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.
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