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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.
Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.
The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flowable composite | Experimental | Flowable composite |
|
| Conventional composite | Active Comparator | Highly filled conventional composite restorative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flowable composite | Device | Restoration of small Class V and I cavities in molar and premolar teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance by Cvar & Ryge Scores | Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present). | baseline, 6, 12 and 24 months |
| Clinical Performance by VAS (Pain Scale) | Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all. | baseline, 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John O Burgess, DDS, MS | Unversity of Alabama at Birmingam Dental School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South | Birmingham | Alabama | 35233-2005 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26237643 | Result | Lawson NC, Radhakrishnan R, Givan DA, Ramp LC, Burgess JO. Two-year Randomized, Controlled Clinical Trial of a Flowable and Conventional Composite in Class I Restorations. Oper Dent. 2015 Nov-Dec;40(6):594-602. doi: 10.2341/15-038-C. Epub 2015 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth |
| 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 | Clinical Performance by Cvar & Ryge Scores | Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present). | Posted | Number | percent of teeth | baseline, 6, 12 and 24 months | teeth | teeth |
|
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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 | All Participants | Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rolf Halvorson | 3M Oral Care Solutions Division | 651-733-3384 | rhhalvorson@mmm.com |
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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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| Conventional composite restorative | Device | Restoration of small Class V and I cavities in molar and premolar teeth |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Conventional Composite | Highly filled conventional composite restorative Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth |
|
|
|
| Primary | Clinical Performance by VAS (Pain Scale) | Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6, 12 and 24 months | teeth | teeth |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
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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 |
| sensitiity to cold 6 Mo |
|
| sensitiity to biting 6 Mo |
|
| sensitiity to cold 12 Mo |
|
| sensitiity to biting 12 Mo |
|
| sensitiity to cold 24 Mo |
|
| sensitiity to biting 24 Mo |
|
| .449 |
| Superiority or Other (legacy) |