High-strength Glass-ionomer Dental Restorations (ROCK)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01523613 |
Recruitment Status
:
Completed
First Posted
: February 1, 2012
Results First Posted
: October 3, 2017
Last Update Posted
: October 3, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Device: Chemfil ROCK Glassionomer restoration Device: Fuji IX GP Extra Glassionomer restoration | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away. |
Primary Purpose: | Treatment |
Official Title: | Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: ROCK - Single Restorations
ChemFil Rock glassionomer restoration
|
Device: Chemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Other Name: HVGIC, HV-GIC, ART materials
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Active Comparator: Fuji IX GP - Single Restorations
Fuji IX GP Extra glassionomer restoration
|
Device: Fuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Other Name: Fuji Equia, HVGIC, HV-GIC, ART materials
|
Active Comparator: 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. |
Device: Chemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Other Name: HVGIC, HV-GIC, ART materials
Device: Fuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Other Name: Fuji Equia, HVGIC, HV-GIC, ART materials
|
- 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.
- Caries Incidence Associated With Restoration [ Time Frame: 2 years ]- "Caries free restorations" is defined as: free of caries associated with restoration.
- 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.

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Ages Eligible for Study: | 7 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523613
United States, Michigan | |
Mott Childrens' Health Center | |
Flint, Michigan, United States, 48503 |
Study Director: | Mathilde C Peters, DMD, PhD | U Michigan |
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 ) |
First Posted: | February 1, 2012 Key Record Dates |
Results First Posted: | October 3, 2017 |
Last Update Posted: | October 3, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |