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

Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05670899
• Other study ID #: 91122
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retention

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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