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Clinical Trials/NCT05622448
NCT05622448
Completed
Not Applicable

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

Cairo University1 site in 1 country30 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Satisfaction
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
patient satisfaction
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
December 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arwa Sedky Abd El-lateef

doctor

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

patient satisfaction

Time Frame: From enrollment to the last follow up

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)

Oral Health Related quality of life

Time Frame: From enrollment to the last follow up

Secondary Outcomes

  • Marginal bone changes.(2 years)

Study Sites (1)

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