Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework in Removable Partial Denture Regarding Retention

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03777280
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This study is aiming to evaluate the retentive forces in PEEK framework RPD compared to Cobalt-Chrome framework RPD during attachment/detachment cycles in mandibular kennedy class I edentulous cases

Condition or Disease	Intervention/Treatment	Phase
Mandibular Prosthesis User	Device: peek framework RPD; Device: cobalt chromium framework RPD	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Retention of Partial Denture Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases
• Anticipated Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: peek framework Removable partial denture polymer-based framework has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.	Device: peek framework RPD; it is a polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base made by injecting technique and have several advantages regarding strength and esthetics
Active Comparator: cobalt chromium framework Removable partial denture it's the gold standard framework which has many benefits such as they are used in thin sections and are less bulky,provide high strength and stiffness,and some disadvantages include hypersensitivity,metal display and oral galvanism,	Device: cobalt chromium framework RPD; standard framework device

Outcome Measures

Primary Outcome Measures

1. Retention [change from baseline retention force after one month and after three months]

   retention force of RPD during attachment/detachment cycles measured by digital force meter device

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• . kennedy class I edentulous subjects indicated for framework partial denture

Exclusion Criteria:

• Uncooperative patients and bad oral hygiene patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Oral and Dental Medicine Cairo University	Cairo	Manial	Egypt	11311

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Souza JE, Silva NR, Coelho PG, Zavanelli AC, Ferracioli RC, Zavanelli RA. Retention strength of cobalt-chromium vs nickel-chromium titanium vs CP titanium in a cast framework association of removable partial overdenture. J Contemp Dent Pract. 2011 May 1;12(3):179-86.

• Responsible Party: Haytham Mohammed talaat ahmed, principle investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03777280
• Other Study ID Numbers: CEBD-CU-2018-11-27
• First Posted: Dec 17, 2018
• Last Update Posted: Dec 17, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cobalt; Chromium

Study Results

No Results Posted as of Dec 17, 2018