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High-strength Glass-ionomer Dental Restorations (ROCK)

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.
 
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

Tracking Information
First Submitted Date  ICMJE January 27, 2012
First Posted Date  ICMJE February 1, 2012
Results First Submitted Date  ICMJE July 15, 2017
Results First Posted Date  ICMJE October 3, 2017
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Survival Rate [ Time Frame: 2 years ]
Survival rate as determined by degree of fractures and retention losses within both arms.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Caries incidence [ Time Frame: 2 years ]
    Caries associated with restoration margins
  • Restored Tooth Performance [ Time Frame: 2 years ]
    Tooth integrity, sensitivity and vitality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-strength Glass-ionomer Dental Restorations
Official Title  ICMJE Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
120
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01523613
Other Study ID Numbers  ICMJE N013822
11-PAF05343 ( Other Identifier: U-Michigan )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mathilde Peters, DMD, PhD, University of Michigan
Study Sponsor  ICMJE Mathilde Peters, DMD, PhD
Collaborators  ICMJE
  • Mott Children's Health Center
  • Dentsply International
Investigators  ICMJE
Study Director: Mathilde C Peters, DMD, PhD U Michigan
PRS Account University of Michigan
Verification Date September 2017

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