Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Device: Removable partial denture PEEK


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Removable partial denture PEEK<br>Removable partial denture using PEEK-acrylic resin | Device: Removable partial denture PEEK<br>* A removable partial denture incorporating PEEK and acrylic resin in its composition used as definitive prosthesis to rehabilitate partial edentulism in the maxilla or mandible.<br>* Other names: PEEK prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the prosthesis | Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the adaptation of the RPD frame | Nominal: 0: adapted; 1: not adapted | one year | 
| Function of RPD is excellent | 5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree | one year | 
| Aesthetics of RPD are excellent | 5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree | one year | 
| Staining of RPD is absent | 5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree | one year | 
| Color stability is maintained | 5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree | one year | 
| Anatomic form of RPD is maintained | 5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree | one year | 
| Incidence of mechanical complications | Loosening or fracture of prosthetic components Nominal: O: absence; 1: presence | one year | 
| Incidence of biological complications | Presence of periodontal pathology Nominal: O: absence; 1: presence | one year | 
| Plaque accumulation around RPD abutment teeth. | Simplified Oral Hygiene Index (Greene and Vermelion, 1964). Ordinal: 0: no debris or stain present; 1: Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered; 2: Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface; 3: Soft debris covering more than two thirds of the exposed tooth surface. | one year | 
| Bleeding around RPO abutment teeth | Gingival index (Loe and Silness 1963)'. Ordinal: 0: absence of inflammation/normal gingiva; 1: mild inflammation, slight change in color, slight edema, no bleeding on probing; 2: moderate inflammation, moderate glazing, redness, edema and hypertrophy, bleeding on probing; 3: severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. | one year | 
| Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters | Measured through probing with a periodontal probe, evaluated on all tooth aspects. Scale: Distance between mucosal margin and probe stop measured in millimeters. | one year | 
| Mobility of RPO abutment teeth | Mobility classification (Miller 1950). Ordinal: 0: no detected mobility; 1: first sign of movement greater than normal; 2: up to 1 mm in any direction; 3: more than 1 mm in any direction and/or vertical depression. | one year | 
| ln mouth comfort | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year | 
| Oral Health Impact Profile OHIP-14 | Oral Health Impact Profile OHIP-14 questionnaire | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthesis, removable partial denture, PEEK