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High-strength Glass-ionomer Dental Restorations (ROCK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523613
First Posted: February 1, 2012
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mott Children's Health Center
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
January 27, 2012
February 1, 2012
July 15, 2017
October 3, 2017
October 3, 2017
November 2011
September 2014   (Final data collection date for primary outcome measure)
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.
Survival Rate [ Time Frame: 2 years ]
Survival rate as determined by degree of fractures and retention losses within both arms.
Complete list of historical versions of study NCT01523613 on ClinicalTrials.gov Archive Site
  • Caries Incidence Associated With Restoration [ Time Frame: 2 years ]
    - "Caries free restorations" is defined as: free of caries associated with restoration.
  • 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.
  • Caries incidence [ Time Frame: 2 years ]
    Caries associated with restoration margins
  • Restored Tooth Performance [ Time Frame: 2 years ]
    Tooth integrity, sensitivity and vitality.
Not Provided
Not Provided
 
High-strength Glass-ionomer Dental Restorations
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.

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.
Interventional
Not Provided
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
Dental Caries
  • 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
  • Active Comparator: ROCK - Single Restorations
    ChemFil Rock glassionomer restoration
    Intervention: Device: Chemfil ROCK Glassionomer restoration
  • Active Comparator: Fuji IX GP - Single Restorations
    Fuji IX GP Extra glassionomer restoration
    Intervention: Device: Fuji IX GP Extra Glassionomer restoration
  • 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.

    Interventions:
    • Device: Chemfil ROCK Glassionomer restoration
    • Device: Fuji IX GP Extra Glassionomer restoration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
October 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01523613
N013822
11-PAF05343 ( Other Identifier: U-Michigan )
No
Not Provided
Plan to Share IPD: Undecided
Mathilde Peters, DMD, PhD, University of Michigan
Mathilde Peters, DMD, PhD
  • Mott Children's Health Center
  • Dentsply International
Study Director: Mathilde C Peters, DMD, PhD U Michigan
University of Michigan
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP