NCT01523613

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 3, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

January 27, 2012

Results QC Date

July 15, 2017

Last Update Submit

September 5, 2017

Conditions

Dental Caries

Keywords

Dental cariesProximal surfacesPosterior teethCarious lesionsTooth diseasesDental restorationsGlass-ionomer

Outcome Measures

Primary Outcomes (1)

  • Survival Rate

    * 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.

    2 years

Secondary Outcomes (2)

  • Caries Incidence Associated With Restoration

    2 years

  • Restored Tooth Performance

    2 years

Study Arms (3)

ROCK - Single Restorations

ACTIVE COMPARATOR

ChemFil Rock glassionomer restoration

Device: Chemfil ROCK Glassionomer restoration

Fuji IX GP - Single Restorations

ACTIVE COMPARATOR

Fuji IX GP Extra glassionomer restoration

Device: Fuji IX GP Extra Glassionomer restoration

Rock AND Fuji - Paired Restorations

ACTIVE COMPARATOR

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.

Device: Chemfil ROCK Glassionomer restorationDevice: Fuji IX GP Extra Glassionomer restoration

Interventions

Chemfil ROCK Glassionomer restorationDEVICE

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

Also known as: HVGIC, HV-GIC, ART materials
ROCK - Single RestorationsRock AND Fuji - Paired Restorations
Fuji IX GP Extra Glassionomer restorationDEVICE

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

Also known as: Fuji Equia, HVGIC, HV-GIC, ART materials
Fuji IX GP - Single RestorationsRock AND Fuji - Paired Restorations

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • year old
  • in need of one or two approximal fillings in molars

You may not qualify if:

  • known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mott Childrens' Health Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

Dental CariesTooth Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationStomatognathic Diseases

Limitations and Caveats

Current study was not designed to investigate wear behavior as final surface treatment was different between the two materials.

Results Point of Contact

Title
Dr. Mathilde Peters
Organization
University of Michigan
mcpete@umich.edu

Study Officials

  • Mathilde C Peters, DMD, PhD

    U Michigan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

November 1, 2011

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

October 3, 2017

Results First Posted

October 3, 2017

Record last verified: 2017-09

Locations

US(1)