Partial Implant-supported Rehabilitation Using PEEK

Prosthesis Survival Clinical Trial

— PEEKPilotSB  

Official title:

Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic 3' Unit Fixed Prosthesis Supported by Dental Implants.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05589519
• Other study ID #: PEEKPilotSB
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: June 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 observational study is to evaluate the outcome of a Poly-ether-ether-ketone

• used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:

• What is the survival outcome of partial implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with dental implants will receive a definitive 3 unit prosthesis incorporating Poly-ether-ehter-ketone.

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 partial rehabilitation using 3 Unit fixed prostheses supported by dental 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 at 4 to 8 weeks, 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing, regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications [loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including denture staining, colour stability and anatomic form; patients' in-mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients rehabilitated with dental implants and a 3 unit Bridge where the molars are missing in one jaw, with at least both canines present;

• 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 who are currently enrolled in a clinical study;

• Subjects requiring or currently having ongoing orthodontic treatment.

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

Device:
• Partial rehabilitation using PEEK
A 3-unit implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis for partial rehabilitation of edentulous jaws.

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 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	Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale	one year
Secondary	Denture staining	Veneer staining; 0:heavily stained; 10: no stains	one year
Secondary	Denture colour stability	Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability	one year
Secondary	Denture anatomic form	Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.	one year
Secondary	Patient tissue reaction	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Secondary	ln mouth comfort	Patient in mouth comfort. Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Secondary	Oral Health Impact Profile OHIP-14	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 Computer assisted design, Computer assisted manufacture, mill and veneering.	one year
Secondary	Clinical operative time	Average operative time to load the final prosthesis	one year