Clinical trial NCT05589519: Partial Implant-supported Rehabilitation Using PEEK
Official title: Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic 3' Unit Fixed Prosthesis Supported by Dental Implants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis Survival
Keywords: prosthesis
dental implants
PEEK
Lead sponsor: Malo Clinic
Sponsor class: OTHER
Collaborators: name: Invibio Ltd
First posted: 2022-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival of the prosthesis
timeFrame: one year
Secondary outcomes:
measure: Survival of the implants
timeFrame: one year
measure: Incidence of biological complications
timeFrame: one year
measure: Incidence of mechanical complications
timeFrame: one year
measure: Marginal bone resorption
timeFrame: one year
measure: Denture staining
timeFrame: one year
measure: Denture colour stability
timeFrame: one year
measure: Denture anatomic form
timeFrame: one year
measure: Patient tissue reaction
timeFrame: one year
measure: ln mouth comfort
timeFrame: one year
measure: Oral Health Impact Profile OHIP-14
timeFrame: one year
measure: Laboratory preparation time
timeFrame: one year
measure: Clinical operative time
timeFrame: one year
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Malo Clinic
Study officials:
affiliation: Director of Research, Development and Education
name: Miguel A de Araújo Nobre, PhD
role: PRINCIPAL_INVESTIGATOR
References: