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High-strength Glass-ionomer Dental Restorations

NCT ID: NCT01523613

Last Updated: 2017-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.

Study Groups

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ROCK - Single Restorations

ChemFil Rock glassionomer restoration

Group Type ACTIVE_COMPARATOR

Chemfil ROCK Glassionomer restoration

Intervention Type DEVICE

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

Fuji IX GP - Single Restorations

Fuji IX GP Extra glassionomer restoration

Group Type ACTIVE_COMPARATOR

Fuji IX GP Extra Glassionomer restoration

Intervention Type DEVICE

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

Rock AND Fuji - Paired Restorations

ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.

While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.

Group Type ACTIVE_COMPARATOR

Chemfil ROCK Glassionomer restoration

Intervention Type DEVICE

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

Fuji IX GP Extra Glassionomer restoration

Intervention Type DEVICE

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

Interventions

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Chemfil ROCK Glassionomer restoration

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

Intervention Type DEVICE

Fuji IX GP Extra Glassionomer restoration

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

Intervention Type DEVICE

Other Intervention Names

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HVGIC, HV-GIC, ART materials Fuji Equia, HVGIC, HV-GIC, ART materials

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mott Children's Health Center

OTHER

Sponsor Role collaborator

Dentsply International

INDUSTRY

Sponsor Role collaborator

Mathilde Peters, DMD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Mathilde Peters, DMD, PhD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mathilde C Peters, DMD, PhD

Role: STUDY_DIRECTOR

U Michigan

Locations

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Mott Childrens' Health Center

Flint, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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11-PAF05343

Identifier Type: OTHER

Identifier Source: secondary_id

N013822

Identifier Type: -

Identifier Source: org_study_id