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Completed

NCT Number: NCT05622448

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

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

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 1234, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RPD with PEEK framework

Other

removable partial denture with CAD designed PEEK framework

RPD with metallic framework

Other

removable partial denture with cobalt chromium framework

Primary outcomes

  1. 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)

  2. Oral Health Related quality of life

    Time frame: From enrollment to the last follow up

Secondary outcomes

  1. Marginal bone changes.

    Time frame: 2 years

    Radiographic follow up will be performed for marginal bone changes.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 18, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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