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

Primary Purpose

Prosthesis Survival

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Removable partial denture PEEK
Sponsored by
Malo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Survival focused on measuring prosthesis, removable partial denture, PEEK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Malo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Removable partial denture PEEK

Arm Description

Removable partial denture using PEEK-acrylic resin

Outcomes

Primary Outcome Measures

Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)

Secondary Outcome Measures

Assessment of the adaptation of the RPD frame
Nominal: 0: adapted; 1: not adapted
Function of RPD is excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Aesthetics of RPD are excellent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Staining of RPD is absent
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Color stability is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Anatomic form of RPD is maintained
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Incidence of mechanical complications
Loosening or fracture of prosthetic components Nominal: O: absence; 1: presence
Incidence of biological complications
Presence of periodontal pathology Nominal: O: absence; 1: presence
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.
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.
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.
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.
ln mouth comfort
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Oral Health Impact Profile OHIP-14
Oral Health Impact Profile OHIP-14 questionnaire

Full Information

First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
Malo Clinic
Collaborators
Invibio Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05589506
Brief Title
Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture
Acronym
PEEKPilotRPD
Official Title
Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malo Clinic
Collaborators
Invibio Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival
Keywords
prosthesis, removable partial denture, PEEK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Removable partial denture PEEK
Arm Type
Experimental
Arm Description
Removable partial denture using PEEK-acrylic resin
Intervention Type
Device
Intervention Name(s)
Removable partial denture PEEK
Other Intervention Name(s)
PEEK prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival of the prosthesis
Description
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Assessment of the adaptation of the RPD frame
Description
Nominal: 0: adapted; 1: not adapted
Time Frame
one year
Title
Function of RPD is excellent
Description
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time Frame
one year
Title
Aesthetics of RPD are excellent
Description
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time Frame
one year
Title
Staining of RPD is absent
Description
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time Frame
one year
Title
Color stability is maintained
Description
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time Frame
one year
Title
Anatomic form of RPD is maintained
Description
5-point Likert scale: strongly agree, agree, neutral, disagree, strongly disagree
Time Frame
one year
Title
Incidence of mechanical complications
Description
Loosening or fracture of prosthetic components Nominal: O: absence; 1: presence
Time Frame
one year
Title
Incidence of biological complications
Description
Presence of periodontal pathology Nominal: O: absence; 1: presence
Time Frame
one year
Title
Plaque accumulation around RPD abutment teeth.
Description
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.
Time Frame
one year
Title
Bleeding around RPO abutment teeth
Description
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.
Time Frame
one year
Title
Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters
Description
Measured through probing with a periodontal probe, evaluated on all tooth aspects. Scale: Distance between mucosal margin and probe stop measured in millimeters.
Time Frame
one year
Title
Mobility of RPO abutment teeth
Description
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.
Time Frame
one year
Title
ln mouth comfort
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
one year
Title
Oral Health Impact Profile OHIP-14
Description
Oral Health Impact Profile OHIP-14 questionnaire
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel A de Araújo Nobre, PhD
Organizational Affiliation
Director of Research, Development and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malo Clinic
City
Lisbon
ZIP/Postal Code
1600-042
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Partial Rehabilitation Using a PEEK-acrylic Resin Removable Partial Denture

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