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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:

MedlinePlus related topics: Eye Wear Tooth Decay

U.S. FDA Resources

Further study details as provided by Mathilde Peters, DMD, PhD, University of Michigan:

Primary Outcome Measures:

Survival rate [ Time Frame: 2 years ]
Survival rate as determined by degree of fractures and retention losses within both arms.

Secondary Outcome Measures:

Caries incidence [ Time Frame: 2 years ]
Caries associated with restoration margins
Restored Tooth Performance [ Time Frame: 2 years ]
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)
Sexes Eligible for Study:	All
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 ( Other Identifier: U-Michigan )
Study First Received:	January 27, 2012
Last Updated:	January 30, 2015

Keywords provided by Mathilde Peters, DMD, PhD, 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 July 24, 2017

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