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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.
Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Universal Composite | Active Comparator | Supreme Universal Restorative |
|
| Flowable Composite | Experimental | Supreme Flowable Restorative |
|
| Bulk Fill Flowable Composite | Experimental | Bulk Fill Flowable Restorative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supreme Universal Restorative | Device |
| ||
| Supreme Flowable Restorative |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Acceptable Restorations | Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months. | 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Luster |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Lawson, DDS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Dental School | Birmingham | Alabama | 35233-2005 | United States |
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53 subjects were evaluated at baseline (3 subjects with 2 sets of restorations). "Number Started" will be greater than the Protocol Enrollment and cannot be revised, however, this is acceptable for split-person studies.
| ID | Title | Description |
|---|---|---|
| FG000 | Universal Composite | This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite |
| FG001 | Flowable Composite | This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite |
| FG002 | Bulk-fill Composite | This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 53 patients were enrolled. Each patient received in different teeth, one restoration of each intervention except for 3 patients who received two restorations of each intervention for a total of 56 teeth per intervention.
| ID | Title | Description |
|---|---|---|
| BG000 | Universal Composite, Flowable Composite, Bulk Fill Flowable Composite | Split-mouth design where each enrolled subject received one or two replicates of three restorative materials: 1) Supreme Universal Restorative, 2) Supreme Flowable Restorative, and/or, 3) Bulk Fill Flowable Restorative |
| 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 | Percent Acceptable Restorations | Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months. | Posted | Number | percentage of restorations survived | 36 Months | Teeth | Teeth |
|
Baseline through 36 months
This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.
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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 | Universal Composite | Supreme Universal Restorative | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment | Principal Investigator did not specify cause of death. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of retention | General disorders | Non-systematic Assessment | Loss of restoration (debond) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel Lawson DMD PhD | UAB School of Dentistry | 205-975-8302 | nlawson@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2020 | Jul 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006330 | Heart Defects, Congenital |
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Single group with a split mouth design in which each subject received all three treatments. Of the 53 total subjects, 3 study subjects actually received duplicate treatment, i.e., they received 6 dental restorations.
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| Device |
|
| Bulk Fill Flowable Restorative | Device |
|
| 36 Month |
| Surface Staining |
| 36 Month |
| Color Match |
| 36 Month |
| Fracture of Material and Retention |
| 36 Month |
| Occlusal Wear - Qualitative |
| 36 Month |
| Tooth Integrity |
| 36 Month |
| Recurrence of Caries, Erosion, Abfraction |
| 36 Months |
| Margin Adaptation |
| 36 Months |
| Marginal Staining |
| 36 Months |
| Proximal Contact Point |
| 36 Months |
| Patient's View |
| 36 Months |
| Post-op Sensitivity |
| 36 Months |
| Protocol Violation |
|
| Exclusion Criteria -change in oral status |
|
| Death |
|
| Teeth |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
|
|
|
| Secondary | Surface Luster |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Surface Staining |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Color Match |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Fracture of Material and Retention |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Occlusal Wear - Qualitative |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Tooth Integrity |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Month | Teeth | Teeth |
|
|
|
|
| Secondary | Recurrence of Caries, Erosion, Abfraction |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| Secondary | Margin Adaptation |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| Secondary | Marginal Staining |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| Secondary | Proximal Contact Point |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| Secondary | Patient's View |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| Secondary | Post-op Sensitivity |
| This population incudes all subjects that completed their three year visit. | Posted | Mean | Standard Deviation | units on a scale | 36 Months | Teeth | Teeth |
|
|
|
|
| 53 |
| 1 |
| 53 |
| 3 |
| 53 |
| EG001 | Flowable Composite | Supreme Flowable Restorative | 1 | 53 | 1 | 53 | 2 | 53 |
| EG002 | Bulk Fill Flowable Composite | Bulk Fill Flowable Restorative | 1 | 53 | 1 | 53 | 4 | 53 |
|
|
| Restoration fracture | General disorders | Non-systematic Assessment |
|
| Pulpitis | General disorders | Non-systematic Assessment | Pulpitis followed by endodontic therapy |
|
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| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |