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

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ClinicalTrials.gov Identifier: NCT03777423
Recruitment Status : Unknown
Verified December 2018 by Amr Hatim Mohammed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Hatim Mohammed, Cairo University

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Mandibular Prosthesis User Device: PEEK framework partial dentures Device: Cobalt- chromium framework partial dentures Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Biting force [ Time Frame: Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months ]
    Biting force of the patient wearing the removable partial denture measured by I-load sensor device.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncooperative patients
  • Bad oral hygiene patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777423


Contacts
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Contact: Amr Ha Mohammed, Master +201001600625 amr_hatim@yahoo.com
Contact: haytham Mo Talaat, master +201210520141 haythamtalaat.zb@gmail.com

Locations
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Egypt
Faculty of oral and dental medincine Cairo university
Cairo, Egypt, 11311
Contact: Hassan Ahmed         
Sponsors and Collaborators
Cairo University
More Information
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Publications of Results:
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.

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Responsible Party: Amr Hatim Mohammed, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03777423    
Other Study ID Numbers: CEBD-CU-2018-11-29
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cobalt
Chromium
Trace Elements
Micronutrients
Physiological Effects of Drugs