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High-strength Glass-ionomer Dental Restorations (ROCK)

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ClinicalTrials.gov Identifier: NCT01523613
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
Mott Children's Health Center
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Dental Caries Device: Chemfil ROCK Glassionomer restoration Device: Fuji IX GP Extra Glassionomer restoration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.
Primary Purpose: Treatment
Official Title: Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
Study Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

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U.S. FDA Resources

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Fuji Equia, HVGIC, HV-GIC, ART materials


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Caries Incidence Associated With Restoration [ Time Frame: 2 years ]
    - "Caries free restorations" is defined as: free of caries associated with restoration.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523613


Locations
United States, Michigan
Mott Childrens' Health Center
Flint, Michigan, United States, 48503
Sponsors and Collaborators
Mathilde Peters, DMD, PhD
Mott Children's Health Center
Dentsply International
Investigators
Study Director: Mathilde C Peters, DMD, PhD U Michigan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mathilde Peters, DMD, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01523613     History of Changes
Other Study ID Numbers: N013822
11-PAF05343 ( Other Identifier: U-Michigan )
First Posted: February 1, 2012    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mathilde Peters, DMD, PhD, University of Michigan:
Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
 Tooth diseases
Dental restorations
Glass-ionomer

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases