High-strength Glass-ionomer Dental Restorations (ROCK)

September 5, 2017 updated by: Mathilde Peters, DMD, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Flint, Michigan, United States, 48503
        • Mott Childrens' Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ROCK - Single Restorations
ChemFil Rock glassionomer restoration
Device: Chemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Other Names:
  • HVGIC, HV-GIC, ART materials
Active Comparator: Fuji IX GP - Single Restorations
Fuji IX GP Extra glassionomer restoration
Device: Fuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Other Names:
  • Fuji Equia, HVGIC, HV-GIC, ART materials
Active Comparator: Rock AND Fuji - Paired Restorations

ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.

While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.
Device: Chemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Other Names:
  • HVGIC, HV-GIC, ART materials
Device: Fuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Other Names:
  • Fuji Equia, HVGIC, HV-GIC, ART materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: 2 years
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Incidence Associated With Restoration
Time Frame: 2 years
- "Caries free restorations" is defined as: free of caries associated with restoration.
2 years
Restored Tooth Performance
Time Frame: 2 years
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mathilde Peters, DMD, PhD

Collaborators

Dentsply International
Mott Children's Health Center

Investigators

  • Study Director: Mathilde C Peters, DMD, PhD, U Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N013822
  • 11-PAF05343 (Other Identifier: U-Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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