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Clinical Trials/NCT05670899
NCT05670899Not yet recruitingNot Applicable

Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks in Mandibular Kennedy Class I Cases: a Randomized Clinical Trial

Cairo University1 site in 1 country20 target enrollmentStarted: March 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Locations
1
Primary Endpoint
retention

Study Overview

Brief Summary

comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses

Detailed Description

partially edentulous patients with Kennedy class I classification will be recruited for the trial and then randomly distributed on two groups; experimental group will receive CAD CAM PEEK partial denture and control group will receive CAD CAM metallic partial denture. then primary impressions will be made and then mouth preparation followed by secondary impression then scanning of the master cast using extra-oral scanner then designing the partial denture using blender for dental then the frame work will be printed.

then frame work will be processed into either PEEK or Metal according to randomization.

retention will be measured at zero and 3 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

  • •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.

Arms & Interventions

CAD PEEK frame-work

Experimental

Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast

Intervention: CAD PEEK frame-work (Procedure)

CAD metallic frame-work

Active Comparator

A metallic framework will be obtained using the conventional lost wax technique and casting. After de-investing, finishing and polishing, the framework will be fitted on the master cast. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally. The finished removable partial denture will then be checked intraorally for any needed modifications and finally delivered.

Intervention: CAD PEEK frame-work (Procedure)

Outcomes

Primary Outcomes

retention

Time Frame: 3 months

Measurements are performed for each RPD at the time of denture insertion, after one month and three months later. Measurements were carried out using digital force gauge which is an advanced type of force meter device, used to measure tension or compression up to 20 Kg

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amr Magdy Ibrahim

assistant lecturer

Cairo University

Study Sites (1)

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