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NCT01523613 Clinical Trial

High-strength Glass-ionomer Dental Restorations

Dental Caries Clinical Trial

— ROCK  

Official title:
Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01523613
Other study ID # N013822
Secondary ID 11-PAF05343
Status Completed
Phase N/A
First received January 27, 2012
Last updated September 5, 2017
Start date November 2011
Est. completion date October 2014

Study information
Verified date September 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.

The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.

Description:

In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 7 Years to 16 Years
Eligibility Inclusion Criteria:

- 7-16 year old

- in need of one or two approximal fillings in molars

Exclusion Criteria:

- known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Chemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
• Fuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.

Locations
Country Name City State
United States Mott Childrens' Health Center Flint Michigan

Sponsors (3)
Lead Sponsor Collaborator
Mathilde Peters, DMD, PhD Dentsply International, Mott Children's Health Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Rate Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms.
"Clinically successful" is defined as: no need for replacement due to fracture or retention losses.		 2 years
Secondary Caries Incidence Associated With Restoration - "Caries free restorations" is defined as: free of caries associated with restoration. 2 years
Secondary Restored Tooth Performance Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.
"Clinically successful" is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality.		 2 years
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