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

NCT03777423 | Unknown

• 1 other identifier: CEBD-CU-2018-11-29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Mandibular Prosthesis User

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PEEK framework partial dentures

EXPERIMENTAL

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

Cobalt-chromium framework partial dentures

ACTIVE COMPARATOR

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

Interventions

PEEK framework partial dentures DEVICE

Polymer-based framework recently introduced made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.

PEEK framework partial dentures

Cobalt- chromium framework partial dentures DEVICE

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

Cobalt-chromium framework partial dentures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Uncooperative patients
• Bad oral hygiene patients

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medincine Cairo university

Cairo, 11311, Egypt

Location

Related 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.

  RESULT

Central Study Contacts

Amr Ha Mohammed, Master

CONTACT

+201001600625; amr_hatim@yahoo.com

haytham Mo Talaat, master

CONTACT

+201210520141; haythamtalaat.zb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

EG (1)