Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

Not Applicable

• Conditions: Prosthesis Survival
• Interventions: Device: Prosthetic single-tooth prosthesis using PEEK

• Registration Number: NCT05589532
• Lead Sponsor: Malo Clinic

Brief Summary

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:

- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.

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 partial rehabilitation using Single Crowns. 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 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 staining, colour stability and anatomical form; patient 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 for economical purposes.

Study Timeline

• Study Start: 2020-08-06
• 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: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

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

Inclusion Criteria

• Patients rehabilitated with a single crown supported by and implant in immediate function;
• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prosthetic single-tooth prosthesis using PEEK	Prosthetic single-tooth prosthesis using PEEK	An implant-supported single tooth prosthesis using a PEEK polymer in its composition

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Malo Clinic; 🇵🇹 Lisbon, Portugal