High-strength Glass-ionomer Dental Restorations

Study Overview
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Chemfil ROCK Glassionomer restoration
* Device: Fuji IX GP Extra Glassionomer restoration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ROCK - Single Restorations<br>ChemFil Rock glassionomer restoration | Device: Chemfil ROCK Glassionomer restoration<br>* High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.<br>* Other names: HVGIC, HV-GIC, ART materials;|
| Active Comparator: Fuji IX GP - Single Restorations<br>Fuji IX GP Extra glassionomer restoration | Device: Fuji IX GP Extra Glassionomer restoration<br>* High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.<br>* Other names: Fuji Equia, HVGIC, HV-GIC, ART materials;|
| Active Comparator: Rock AND Fuji - Paired Restorations<br>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<br>* High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.<br>* Other names: HVGIC, HV-GIC, ART materials;Device: Fuji IX GP Extra Glassionomer restoration<br>* High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.<br>* Other names: Fuji Equia, HVGIC, HV-GIC, ART materials;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Incidence Associated With Restoration | - Caries free restorations is defined as: free of caries associated with restoration. | 2 years | 
| Restored Tooth Performance | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Glass-ionomer