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High-strength Glass-ionomer Dental Restorations (ROCK)

This study has been completed.
Sponsor:
Collaborators:
Mott Children's 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: January 30, 2015
Last verified: January 2015
History of Changes
  Purpose

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 Intervention Phase
Dental Caries
 Device: Glassionomer restoration
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 63
Study Start Date: November 2011
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ROCK restorative
ChemFil Rock glassionomer restoration
 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: Fuji IX GP restorative
Fuji IX GP glassionomer restoration
 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

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.
  Eligibility
Ages Eligible for Study:   7 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Mathilde Peters, DMD, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01523613     History of Changes
Other Study ID Numbers: N013822  11-PAF05343 
Study First Received: January 27, 2012
Last Updated: January 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016