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High-strength Glass-ionomer Dental Restorations (ROCK)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Mott Childrens' Health Center
Dentsply International
Information provided by (Responsible Party):
Mathilde C Peters, University of Michigan
ClinicalTrials.gov Identifier:
NCT01523613
First received: January 27, 2012
Last updated: January 31, 2012
Last verified: January 2012
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: Dental 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.


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ROCK restorative
ChemFil Rock glassionomer restorative system
 Device: Dental restoration
High-viscous glassionomer restoratives used as posterior dental filling materials.
Other Name: HVGIC, HV-GIC, ART materials
Active Comparator: Fuji IX GP restorative
Fuji IX GP glassionomer restorative system
 Device: Dental restoration
High-viscous glassionomer restoratives used as posterior dental filling materials.
Other Name: 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
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
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 C Peters
Mott Childrens' Health Center
Dentsply International
Investigators
Study Director: Mathilde C Peters, DMD, PhD U Michigan
  More Information

No publications provided

Responsible Party: Mathilde C Peters, 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 31, 2012
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 May 16, 2013