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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03777345
Other study ID # CEBD-CU-2018-11-28
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2019

Study information

Verified date December 2018
Source Cairo University
Contact Ahmed He Zidan, master
Phone +201126534668
Email ahmedhefnyf@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Kennedy Class I partially edentulous subjects indicated for framework partial denture

Exclusion Criteria:

- 1- uncooperative patients . 2- bad oral hygiene patients .

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cobalt-chromium framework partial dentures
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 .
PEEK framework partial dentures
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.

Locations

Country Name City State
Egypt Faculty of Oral and Dental Medicine Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 .
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04868825 - Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up N/A
Completed NCT03150472 - Safety and Efficacy Evaluation of the Ivory Dentin Graft Device N/A
Not yet recruiting NCT03777423 - Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Biting Force N/A
Not yet recruiting NCT03777280 - Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework in Removable Partial Denture Regarding Retention N/A
Completed NCT02736994 - Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures N/A