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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Patient Satisfaction

Treatments

Other: RPD with PEEK framework
Other: RPD with metallic framework

Study type

Interventional

Funder types

Other

Identifiers

NCT05622448
patient satisfaction and RPD

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

RPD with metallic framework
Active Comparator group
Description:
removable partial denture with cobalt chromium framework
Treatment:
Other: RPD with metallic framework
Other: RPD with PEEK framework
RPD with PEEK framework
Experimental group
Description:
removable partial denture with poly ether ether ketone framework
Treatment:
Other: RPD with metallic framework
Other: RPD with PEEK framework

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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