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| ID | Type | Description | Link |
|---|---|---|---|
| 11-PAF05343 | Other Identifier | U-Michigan |
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| Name | Class |
|---|---|
| Mott Children's Health Center | OTHER |
| Dentsply International | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROCK - Single Restorations | Active Comparator | ChemFil Rock glassionomer restoration |
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| Fuji IX GP - Single Restorations | Active Comparator | Fuji IX GP Extra glassionomer restoration |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemfil ROCK Glassionomer restoration | Device | High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate |
| 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde C Peters, DMD, PhD | U Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mott Childrens' Health Center | Flint | Michigan | 48503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ChemFil Rock Restoration (R) | Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration) |
| FG001 | Fuji IX Restoration (F) | Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus). |
| FG002 | Paired Restorations (Rock + Fuji) | 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 restorative and 1 Fuji IX GP restorative. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ChemFil Rock Restoration (R-single) | Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration) |
| BG001 | Fuji IX Restoration (F-single) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival Rate |
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| Posted | Count of Units | Restorations | 2 years | Restorations | Restorations |
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2 years (up to 26 months in individual cases)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rock-restored Tooth (R-tooth) | Tooth restored with a ChemFil Rock filling. | 0 |
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Current study was not designed to investigate wear behavior as final surface treatment was different between the two materials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mathilde Peters | University of Michigan | mcpete@umich.edu |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D009057 | Stomatognathic Diseases |
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Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.
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| Fuji IX GP Extra Glassionomer restoration | Device | High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material. |
|
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| 2 years |
Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus). |
| BG002 | Paired Restorations (1R and 1F) | 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 restorative and 1 Fuji IX GP restorative. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 |
| Fuji IX Restoration (F) |
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus |
|
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| Secondary | Caries Incidence Associated With Restoration | - "Caries free restorations" is defined as: free of caries associated with restoration. |
| Posted | Count of Units | Restoration | 2 years | Restoration | Restoration |
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| Secondary | Restored Tooth Performance |
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| Posted | Count of Units | Restored tooth | 2 years | Restored tooth | Restored tooth |
|
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|
|
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Fuji-restored (F-tooth) | Tooth restored with a Fuji IX GP Extra filling. | 0 | 63 | 0 | 63 | 0 | 63 |
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