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

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

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 .

Study Overview

• Status: Unknown
• Conditions: Mandibular Prosthesis User
• Intervention / Treatment: Device: PEEK framework partial dentures; Device: Cobalt- chromium framework partial dentures

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amr Ha Mohammed, master; Phone Number: +201001600625; Email: amr_hatim@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Faculty of oral and dental medincine Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Uncooperative patients
• Bad oral hygiene patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEK framework partial dentures; High performance ketone polymers introduced lately.These polymer-based frameworks provide better esthetics, higher elasticity, lighter in weight, have low water sorption and solubility, and are easily repaired and reproduced.	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.
Active Comparator: Cobalt-chromium framework partial dentures; it is considered the gold standard framework. These frameworks are less bulky with high strength, conduct heat and electricity well, and have good durability. some disadvantages include hypersensitivity, adverse tissue reactions and bad aesthetics.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium; Cobalt
• Other Study ID Numbers: CEBD-CU-2018-11-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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