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Completed

NCT Number: NCT01523613

High-strength Glass-ionomer Dental Restorations

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mott Childrens' Health Center

Flint, Michigan, 48503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemfil ROCK Glassionomer restoration

Device

High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.

Other names: HVGIC, HV-GIC, ART materials

Fuji IX GP Extra Glassionomer restoration

Device

High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.

Other names: Fuji Equia, HVGIC, HV-GIC, ART materials

Primary outcomes

  1. 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.

Secondary outcomes

  1. Caries Incidence Associated With Restoration

    Time frame: 2 years

    • "Caries free restorations" is defined as: free of caries associated with restoration.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mathilde Peters, DMD, PhD

Other

Collaborators

  • Dentsply International
  • Mott Children's Health Center

Registry information

Official study title

Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions

Acronym: ROCK

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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