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High-strength Glass-ionomer Dental Restorations (ROCK)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mott Childrens' Health Center
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01523613
First received: January 27, 2012
Last updated: November 13, 2013
Last verified: November 2013

January 27, 2012
November 13, 2013
November 2011
August 2014   (final data collection date for primary outcome measure)
Survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Survival rate as determined by degree of fractures and retention losses within both arms.
Same as current
Complete list of historical versions of study NCT01523613 on ClinicalTrials.gov Archive Site
  • Caries incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Caries associated with restoration margins
  • Restored Tooth Performance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Tooth integrity, sensitivity and vitality.
Same as current
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
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Dental Caries
Device: Glassionomer restoration
High-viscous glassionomer restoration used as posterior dental filling material.
Other Names:
  • Chemfil ROCK
  • Fuji IX GP
  • HVGIC, HV-GIC, ART materials
  • Active Comparator: ROCK restorative
    ChemFil Rock glassionomer restoration
    Intervention: Device: Glassionomer restoration
  • Active Comparator: Fuji IX GP restorative
    Fuji IX GP glassionomer restoration
    Intervention: Device: Glassionomer restoration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
September 2014
August 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
Both
7 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01523613
N013822, 11-PAF05343
No
Mathilde Peters, DMD, PhD, University of Michigan
Mathilde Peters, DMD, PhD
  • Mott Childrens' Health Center
  • Dentsply International
Study Director: Mathilde C Peters, DMD, PhD U Michigan
University of Michigan
November 2013

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