Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture (PEEKPilotRPD)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthesis Survival
• Intervention / Treatment: Device: Removable partial denture PEEK

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1600-042
    • Malo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Removable partial denture PEEK; Removable partial denture using PEEK-acrylic resin	Device: Removable partial denture PEEK; 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.; Other Names: PEEK prosthesis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Malo Clinic
• Collaborators: Invibio Ltd
• Investigators: Principal Investigator: Miguel A de Araújo Nobre, PhD, Director of Research, Development and Education

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: prosthesis; PEEK; removable partial denture
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: PEEKPilotRPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized database containing the study variables
• IPD Sharing Time Frame: Upon study completion and for 8 years.
• IPD Sharing Access Criteria: Upon solicitation to the Investigators
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No