Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth

NCT03777345 | Unknown

• 1 other identifier: CEBD-CU-2018-11-28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aiming to evaluate the periodontal status of the abutment teeth in Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal health of the abutment teeth .

Conditions

Mandibular Prosthesis User

Outcome Measures

Primary Outcomes (1)

• Periodontal status

  periodontal status of the abutment teeth assessed by a periodontal chart .

  Change in periodontal status will be assessed at base line , after one month and after 3 months .

Study Arms (2)

cobalt-chromium framework partial dentures

ACTIVE COMPARATOR

It's the gold standard biocompatible metal alloy used in thin sections, provide high strength and stiffness ,conduct heat and cold for a more natural experience, and is resistant to corrosion but their disadvantages include esthetic issues with metal display, oral galvanism, adverse tissue reactions,and osteolysis of abutment teeth.

Device: cobalt-chromium framework partial dentures

PEEK framework partial dentures

EXPERIMENTAL

It's a promising 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 partial dentures

Interventions

cobalt-chromium framework partial dentures DEVICE

It's a biocompatible metal alloy used in thin sections and are 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 is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .

cobalt-chromium framework partial dentures

PEEK framework partial dentures DEVICE

It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.

PEEK 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 I partially edentulous subjects indicated for framework partial denture

You may not qualify if:

• uncooperative patients . 2- bad oral hygiene patients .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine Cairo University

Cairo, 11311, Egypt

Location

Related Publications (1)

• Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.

  BACKGROUND

Central Study Contacts

Ahmed He Zidan, master

CONTACT

+201126534668; ahmedhefnyf@gmail.com

Amr Ha Mohammed, master

CONTACT

+201001600625; amr_hatim@yahoo.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)