Dental Caries, Restorative Material
Conditions
Keywords
restorative material
Brief summary
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
Detailed description
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..
Interventions
DEVICEurethane dimethacrylate
Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent
DEVICETPH3
light-cured resin composite for teeth
DEVICEEsthet-X HD
light cured resin composite for teeth made by Dentsply Caulk
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
• must have given written consent to participate in the trial * must be in need of at least two restorations in natural tooth * replacement restorations with or without caries are acceptable * must be available for the required post-operative follow-up visits * restorations to be in bicuspids, 1st or 2nd molars * restorations to be in contact with opposing natural or crowned teeth * class II restorations must have at least one proximal contact * restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips * 75% of the restorations must be Class II * all restorations must have at least one occlusal contact in habitual closure
Exclusion criteria
* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) or disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene * have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients * have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored * have a history of chronic bruxism and those unavailable for long term recall * can not tolerate the rubber dam required for tooth isolation during preparation and restoration. * do not meet all inclusion criteria * present with any systemic or local disorders that contra-indicate the dental procedures included in this study * have an unstable occlusion * have severe bruxing or clenching or need of TMJ related therapy * have teeth with periapical pathology or expected pulp exposures * have teeth that are non-vital or that exhibit signs of pulpal pathology * Pregnancy * Known sensitivity to methacrylates and/or acrylates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Teeth With Anatomic Form Graded as A or B. | 24 months | 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. |
| Percent of Teeth Scored as A or B for Color Match | 24 months | 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. |
| Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | 24 months | 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 |
| Percent of Teeth With Marginal Discoloration of A or B | 24 months | 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. |
| Percent of Teeth With Proximal Contact | 24 months | 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 |
| Percent of Teeth With Polish-ability of A, B1 or B2 | 24 months | A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| UDMA and TPHs Participants who needed at least two tooth restorations | 50 |
| Esthet-X HD Participants who needed at least two tooth restorations | 35 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | filling replaced by crown | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 6 | 5 |
| Overall Study | Physician Decision | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | UDMA and TPHs | Esthet-X HD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 35 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 31 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 42 Participants | 27 Participants | 69 Participants |
| Region of Enrollment United States | 50 participants | 35 participants | 85 participants |
| Sex: Female, Male Female | 36 Participants | 23 Participants | 59 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 35 |
| other Total, other adverse events | 0 / 50 | 2 / 50 | 1 / 35 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 35 |
Outcome results
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth Scored as A or B for Color Match | A | 41 teeth |
| Teeth That Received UDMA | Percent of Teeth Scored as A or B for Color Match | B | 3 teeth |
| Teeth That Received TPH3 | Percent of Teeth Scored as A or B for Color Match | A | 40 teeth |
| Teeth That Received TPH3 | Percent of Teeth Scored as A or B for Color Match | B | 2 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth Scored as A or B for Color Match | A | 40 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth Scored as A or B for Color Match | B | 1 teeth |
p-value: 0.2235Chi-squared
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth With Anatomic Form Graded as A or B. | A | 42 teeth |
| Teeth That Received UDMA | Percent of Teeth With Anatomic Form Graded as A or B. | B | 2 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Anatomic Form Graded as A or B. | A | 37 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Anatomic Form Graded as A or B. | B | 5 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Anatomic Form Graded as A or B. | A | 40 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Anatomic Form Graded as A or B. | B | 1 teeth |
p-value: 0.2552Chi-squared
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth With Marginal Discoloration of A or B | A | 39 teeth |
| Teeth That Received UDMA | Percent of Teeth With Marginal Discoloration of A or B | B | 5 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Marginal Discoloration of A or B | A | 40 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Marginal Discoloration of A or B | B | 2 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Marginal Discoloration of A or B | A | 39 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Marginal Discoloration of A or B | B | 2 teeth |
p-value: 0.3883Chi-squared
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
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B1 | 2 teeth |
| Teeth That Received UDMA | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | A | 39 teeth |
| Teeth That Received UDMA | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B2 | 3 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B1 | 4 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | A | 36 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B2 | 2 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | A | 39 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B2 | 1 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Marginal Integrity Graded A, B1 and B2 | B1 | 1 teeth |
p-value: 0.3891Chi-squared
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
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth With Polish-ability of A, B1 or B2 | B1 | 2 teeth |
| Teeth That Received UDMA | Percent of Teeth With Polish-ability of A, B1 or B2 | A | 41 teeth |
| Teeth That Received UDMA | Percent of Teeth With Polish-ability of A, B1 or B2 | B2 | 1 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Polish-ability of A, B1 or B2 | B1 | 1 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Polish-ability of A, B1 or B2 | A | 40 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Polish-ability of A, B1 or B2 | B2 | 1 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Polish-ability of A, B1 or B2 | A | 40 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Polish-ability of A, B1 or B2 | B2 | 0 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Polish-ability of A, B1 or B2 | B1 | 1 teeth |
p-value: 0.2707Chi-squared
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
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teeth That Received UDMA | Percent of Teeth With Proximal Contact | A | 32 teeth |
| Teeth That Received UDMA | Percent of Teeth With Proximal Contact | B | 4 teeth |
| Teeth That Received UDMA | Percent of Teeth With Proximal Contact | C | 1 teeth |
| Teeth That Received UDMA | Percent of Teeth With Proximal Contact | NA | 7 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Proximal Contact | NA | 9 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Proximal Contact | A | 28 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Proximal Contact | C | 1 teeth |
| Teeth That Received TPH3 | Percent of Teeth With Proximal Contact | B | 4 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Proximal Contact | NA | 10 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Proximal Contact | B | 2 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Proximal Contact | C | 0 teeth |
| Teeth That Received Esthet-X-HD | Percent of Teeth With Proximal Contact | A | 29 teeth |
p-value: 0.3883Chi-squared