NCT03777280

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 11, 2018

Last Update Submit

December 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retention

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

    change from baseline retention force after one month and after three months

Study Arms (2)

peek framework Removable partial denture

EXPERIMENTAL

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

cobalt chromium framework Removable partial denture

ACTIVE COMPARATOR

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

Interventions

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

peek framework Removable partial denture

standard framework device

cobalt chromium framework Removable partial denture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • kennedy class I edentulous subjects indicated for framework partial denture

You may not qualify if:

  • Uncooperative patients and bad oral hygiene patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine Cairo University

Cairo, Manial, 11311, Egypt

Location

Related Publications (1)

  • 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. doi: 10.5005/jp-journals-10024-1031.

    PMID: 22186813BACKGROUND

Central Study Contacts

haytham mo talaat, master

CONTACT

ahmed hefny zidan, master

CONTACT

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