Clinical trial NCT05589506: Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture
Official title: Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis Survival
Keywords: prosthesis
removable partial denture
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 - acrylic resin removable partial denture used in partial edentulous rehabilitation after one year of follow-up. The main question it aims to answer is:

- What is the survival outcome of partial rehabilitations using Poly-ether-ether-ketone-acrylic resin removable partial dentures? The participants will receive a definitive removable partial denture incorporating Poly-ether-ehter-ketone.

Detailed description: Folowing the recent applications of polyetheretherketone (PEEK) material in Dentistry it is necessary to further extend the evaluation to the use of Removable Partial Denture (RPD) rehabilitations. 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 the Removal Partial Denture (RPO) supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated at baseline, RPD design, dental fitting, follow-up assessment at 4 weeks, 6 and 12 months after dental loading regarding: JUVORA prosthetic survival including repair and relining, assessment of the adaptation of the RPD frame, adaptation of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetics assessment (staining, color stability, anatomic form), oral health assessment of the RPD abutment teeth periodontium (plaque index, gingival index, probing pocket depths, bleeding on probing, mobility) incidence of mechanical complications (loosening or fracture of prosthetic components), patient assessment of RPD comfort, aesthetics and chewing ability; assessment of RPD preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

Eligibility criteria: Inclusion Criteria:

* partial edentulism with at least a posterior natural tooth occlusaI stop (molar or premolar), defined as Kennedy's Class I, Class lI or Class lII,
* occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest;
* previous denture wearing experience,
* stable oral health in terms of absence of disease activity affecting the periodontium, caries, pulp and the structural/aesthetic integrity of restored teeth.
* 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 requiring extensive treatment prior to the provision of a removable partial denture;
* 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;
* Subjects with an opposing Removable Partial Denture (RPD).

Primary outcomes:
measure: Survival of the prosthesis
timeFrame: one year
Secondary outcomes:
measure: Assessment of the adaptation of the RPD frame
timeFrame: one year
measure: Function of RPD is excellent
timeFrame: one year
measure: Aesthetics of RPD are excellent
timeFrame: one year
measure: Staining of RPD is absent
timeFrame: one year
measure: Color stability is maintained
timeFrame: one year
measure: Anatomic form of RPD is maintained
timeFrame: one year
measure: Incidence of mechanical complications
timeFrame: one year
measure: Incidence of biological complications
timeFrame: one year
measure: Plaque accumulation around RPD abutment teeth.
timeFrame: one year
measure: Bleeding around RPO abutment teeth
timeFrame: one year
measure: Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters
timeFrame: one year
measure: Mobility of RPO abutment teeth
timeFrame: one year
measure: ln mouth comfort
timeFrame: one year
measure: Oral Health Impact Profile OHIP-14
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: