Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Biting Force

Mandibular Prosthesis User Clinical Trial

Official title:

Evaluation of Biting Force of Removable Partial Denture Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03777423
• Other study ID #: CEBD-CU-2018-11-29
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: Amr Ha Mohammed, Master
• Phone: +201001600625
• Email: amr_hatim[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aiming to evaluate the biting force of polyetheretherketone (PEEK) framework partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures can improve the patient masticatory efficiency .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Kennedy class 1 partially edentulous subjects indicated for framework partial denture

Exclusion Criteria:

• Uncooperative patients

• Bad oral hygiene patients

Related Conditions & MeSH terms

• Mandibular Prosthesis User

Intervention

Device:
• PEEK framework partial dentures
Polymer-based framework recently introduced made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
• Cobalt- chromium framework partial dentures
It's a bio-compatible metal used in thin sections so less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medincine Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Al-Jammali ZM. Clinical Evaluation of Maximum Bite Force in Patient with Heat Cure acrylic and Flexible Partial Dentures. Medical Journal of Babylon. 2017;14(3):509-17.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biting force	Biting force of the patient wearing the removable partial denture measured by I-load sensor device.	Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months