An interventional study of urethane dimethacrylate and TPH3 in Dental Caries and Restorative Material, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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..
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 85 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:• must have given written consent to participate in the trial
Exclusion Criteria:
Participants who needed at least two tooth restorations
Device: urethane dimethacrylate · Device: TPH3 · Device: Esthet-X HD
Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent
light-cured resin composite for teeth
light cured resin composite for teeth made by Dentsply Caulk
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 24 months
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
Time frame: 24 months
| Milestone | UDMA | TPH3 | Esthet-X |
|---|---|---|---|
| Started | 50 | 50 | 35 |
| Completed | 44 | 42 | 29 |
| Not completed | 6 | 8 | 6 |
| Withdrew: Filling replaced by crown | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 6 | 6 | 5 |
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.
| teeth | Teeth That Received UDMA | Teeth That Received TPH3 | Teeth That Received Esthet-X-HD |
|---|---|---|---|
| A | 42 | 37 | 40 |
| B | 2 | 5 | 1 |
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.
| teeth | UDMA | TPH3 | Participants That Completed Esthet-X Intervention |
|---|---|---|---|
| A | 41 | 40 | 40 |
| B | 3 | 2 | 1 |
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
| teeth | Teeth That Received UDMA | Teeth That Received TPH3 | Teeth That Received Esthet-X-HD |
|---|---|---|---|
| A | 39 | 36 | 39 |
| B1 | 2 | 4 | 1 |
| B2 | 3 | 2 | 1 |
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.
| teeth | Teeth That Received UDMA | Teeth That Received TPH3 | Teeth That Received Esthet-X-HD |
|---|---|---|---|
| A | 39 | 40 | 39 |
| B | 5 | 2 | 2 |
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
| teeth | Teeth That Received UDMA | Teeth That Received TPH3 | Teeth That Received Esthet-X-HD |
|---|---|---|---|
| A | 32 | 28 | 29 |
| B | 4 | 4 | 2 |
| C | 1 | 1 | 0 |
| NA | 7 | 9 | 10 |
A= Smooth \& highly shiny, similar to enamel B1= Smooth \& satin, highly reflective B2= Smooth \& shiny but not highly reflective
| teeth | Teeth That Received UDMA | Teeth That Received TPH3 | Teeth That Received Esthet-X-HD |
|---|---|---|---|
| A | 41 | 40 | 40 |
| B1 | 2 | 1 | 1 |
| B2 | 1 | 1 | 0 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UDMA | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| TPH3 | 0/50 (0%) | 0/50 (0%) | 2/50 (4%) |
| Esthet-X HD | 0/35 (0%) | 0/35 (0%) | 1/35 (2.9%) |
| Event | UDMA | TPH3 | Esthet-X HD |
|---|---|---|---|
| No response on tooth vitality testGeneral disorders | 0/50 | 2/50 | 1/35 |
50 participants were enrolled. Each received the UDMA and TPH3 interventions. 35 were enrolled to recieve the Esthet-X intervention.
| Age, Categorical(Participants) | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 35 | 85 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| Female | 36 | 23 | 59 |
| Male | 14 | 12 | 26 |
| Ethnicity (NIH/OMB)(Participants) | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 3 | 12 |
| Not Hispanic or Latino | 41 | 31 | 72 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 9 |
| White | 42 | 27 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| United States | 50 | 35 | 85 |
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