Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Retention
• Intervention / Treatment: Procedure: CAD PEEK frame-work

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 11555
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAD PEEK frame-work; 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	Procedure: CAD PEEK frame-work; 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
Active Comparator: CAD metallic frame-work; 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.	Procedure: CAD PEEK frame-work; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention	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	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2023
• Primary Completion (Anticipated): April 20, 2023
• Study Completion (Anticipated): August 20, 2023

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 91122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No