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This double blind randomized controlled prospective clinical trial will compare the clinical success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk) and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the posterior restorations for 24 months in duration
The purposes of this clinical trial is to evaluate two composite resins used to restore Class I and Class II cavities in teeth of adults. The clinical study will evaluate the resin composite restorations placed in Class I and Class II cavity preparations for anatomic form, color match, marginal integrity, marginal discoloration, proximal contact, polishability, caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | Participants who needed at least two tooth restorations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urethane dimethacrylate | Device | Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Teeth With Anatomic Form Graded as A or B. | Anatomic form was graded as: A=The restoration is continuous with existing form. B=The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. | 24 months |
| Percent of Teeth Scored as A or B for Color Match | A=The restoration appears to match the shade and translucency of adjacent tooth structure. B=The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. | 24 months |
| Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | A= No visible evidence of a crevice along the margin into which the explorer will penetrate B1= Explorer clicks on the margin B2= Visible evidence of a crevice | 24 months |
| Percent of Teeth With Marginal Discoloration of A or B | A= There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B= There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. | 24 months |
| Percent of Teeth With Proximal Contact | A= Tight proximal contacts evaluated with dental floss. B= Proximal contacts are weak but present. C= No proximal contacts but not visibly open. NA= Class I restorations | 24 months |
| Percent of Teeth With Polish-ability of A, B1 or B2 |
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Inclusion Criteria:• must have given written consent to participate in the trial
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester, Eastman Institute for Oral Health | Rochester | New York | 14620 | United States |
50 participants received both TPH3 and UDMA in a split-face design, with the most anterior or right tooth randomized to one intervention and the most posterior or left tooth randomized to the second intervention. An additional 35 participants were included for treatment with Esthet-X and could receive the intervention on more than one tooth.
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| ID | Title | Description |
|---|---|---|
| FG000 | UDMA | Participants who needed at least two tooth restorations urethane dimethacrylate: Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent TPH3: light-cured resin composite for teeth Esthet-X HD: light cured resin composite for teeth made by Dentsply Caulk |
| FG001 | TPH3 | Participants who needed at least two tooth restorations TPH3: light-cured resin composite for teeth |
| FG002 | Esthet-X | Participants who needed at least two tooth restorations |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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50 participants were enrolled. Each received the UDMA and TPH3 interventions. 35 were enrolled to recieve the Esthet-X intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | UDMA and TPHs | Participants who needed at least two tooth restorations |
| BG001 | Esthet-X HD | Participants who needed at least two tooth restorations |
| Units | Counts |
|---|---|
| Participants |
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| 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 of Teeth With Anatomic Form Graded as A or B. | Anatomic form was graded as: A=The restoration is continuous with existing form. B=The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine. | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
|
24 months
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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 | UDMA | Experimental urethane dimethacrylate resin based composite resin for teeth used with prime an Bond Elect bonding agent |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| No response on tooth vitality test | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hans Malmstrom | University of Rochester | 585-275-5087 | hans_malmstrom@urmc.rochester.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 | Mar 7, 2013 | Jun 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| TPH3 | Device | light-cured resin composite for teeth |
|
| Esthet-X HD | Device | light cured resin composite for teeth made by Dentsply Caulk |
|
A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective |
| 24 months |
| Lost to Follow-up |
|
| BG002 | 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 | Number | participants |
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light-cured resin composite for teeth
| OG002 | Teeth That Received Esthet-X-HD | light cured resin composite for teeth made by Dentsply Caulk |
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| Primary | Percent of Teeth Scored as A or B for Color Match | A=The restoration appears to match the shade and translucency of adjacent tooth structure. B=The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency. | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
|
|
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| Primary | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | A= No visible evidence of a crevice along the margin into which the explorer will penetrate B1= Explorer clicks on the margin B2= Visible evidence of a crevice | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
|
|
|
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| Primary | Percent of Teeth With Marginal Discoloration of A or B | A= There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure. B= There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
|
|
|
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| Primary | Percent of Teeth With Proximal Contact | A= Tight proximal contacts evaluated with dental floss. B= Proximal contacts are weak but present. C= No proximal contacts but not visibly open. NA= Class I restorations | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
|
|
|
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| Primary | Percent of Teeth With Polish-ability of A, B1 or B2 | A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective | Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point. | Posted | Count of Units | teeth | 24 months | teeth | teeth |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | TPH3 | Light-cured resin composite for teeth | 0 | 50 | 0 | 50 | 2 | 50 |
| EG002 | Esthet-X HD | Light cured resin composite for teeth made by Dentsply Caulk | 0 | 35 | 0 | 35 | 1 | 35 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| B2 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| C |
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| NA |
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| Title | Measurements |
|---|---|
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| B2 |
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