Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and (PEEK) Partial Denture Frameworks

Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks

To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: RPD with PEEK framework; Other: RPD with metallic framework

Detailed Description

The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).

Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the abutments.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1234
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
2. Opposing dentition is fully intact or restored.
3. Sufficient inter-arch space.
4. Angle's class I maxilla-mandibular relationship.

Exclusion Criteria:

1. Periodontal affection of the abutment teeth.
2. Skeletal mal-relation.
3. Unmotivated patients to maintain adequate oral hygiene to follow up.
4. Patients with neuromuscular and Psychiatric disorders.
5. Systematic disease affecting bone and periodontal health.
6. Insufficient inter-arch space.
7. Patients with physical reasons that could affect follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RPD with metallic framework; removable partial denture with cobalt chromium framework	Other: RPD with PEEK framework; removable partial denture with CAD designed PEEK framework; Other: RPD with metallic framework; removable partial denture with cobalt chromium framework
Experimental: RPD with PEEK framework; removable partial denture with poly ether ether ketone framework	Other: RPD with PEEK framework; removable partial denture with CAD designed PEEK framework; Other: RPD with metallic framework; removable partial denture with cobalt chromium framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q. likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)	From enrollment to the last follow up
Oral Health Related quality of life		From enrollment to the last follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone changes.	Radiographic follow up will be performed for marginal bone changes.	2 years

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: removable partial denture; peek framework; co-cr framework
• Other Study ID Numbers: patient satisfaction and RPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No