Trial Outcomes & Findings for Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material (NCT NCT02018822)

NCT ID: NCT02018822

Last Updated: 2018-08-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2018-08-28

Participant Flow

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.

Unit of analysis: teeth

Participant milestones

Measure	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	TPH3 Participants who needed at least two tooth restorations TPH3: light-cured resin composite for teeth	Esthet-X Participants who needed at least two tooth restorations
Overall Study STARTED	50 50	50 50	35 50
Overall Study COMPLETED	44 44	42 42	29 41
Overall Study NOT COMPLETED	6 6	8 8	6 9

Reasons for withdrawal

Measure	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	TPH3 Participants who needed at least two tooth restorations TPH3: light-cured resin composite for teeth	Esthet-X Participants who needed at least two tooth restorations
Overall Study filling replaced by crown	0	1	0
Overall Study Physician Decision	0	1	1
Overall Study Lost to Follow-up	6	6	5

Baseline Characteristics

Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material

Baseline characteristics by cohort

Measure	UDMA and TPHs n=50 Participants Participants who needed at least two tooth restorations	Esthet-X HD n=35 Participants Participants who needed at least two tooth restorations	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=93 Participants	35 Participants n=4 Participants	85 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	23 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=93 Participants	31 Participants n=4 Participants	72 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) White	42 Participants n=93 Participants	27 Participants n=4 Participants	69 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	50 participants n=93 Participants	35 participants n=4 Participants	85 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth With Anatomic Form Graded as A or B. A	42 teeth	37 teeth	40 teeth
Percent of Teeth With Anatomic Form Graded as A or B. B	2 teeth	5 teeth	1 teeth

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth Scored as A or B for Color Match A	41 teeth	40 teeth	40 teeth
Percent of Teeth Scored as A or B for Color Match B	3 teeth	2 teeth	1 teeth

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth With Marginal Integrity Graded A, B1 and B2 A	39 teeth	36 teeth	39 teeth
Percent of Teeth With Marginal Integrity Graded A, B1 and B2 B1	2 teeth	4 teeth	1 teeth
Percent of Teeth With Marginal Integrity Graded A, B1 and B2 B2	3 teeth	2 teeth	1 teeth

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth With Marginal Discoloration of A or B A	39 teeth	40 teeth	39 teeth
Percent of Teeth With Marginal Discoloration of A or B B	5 teeth	2 teeth	2 teeth

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth With Proximal Contact A	32 teeth	28 teeth	29 teeth
Percent of Teeth With Proximal Contact B	4 teeth	4 teeth	2 teeth
Percent of Teeth With Proximal Contact C	1 teeth	1 teeth	0 teeth
Percent of Teeth With Proximal Contact NA	7 teeth	9 teeth	10 teeth

PRIMARY outcome

Timeframe: 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.

A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective

Outcome measures

Measure	Teeth That Received UDMA n=44 teeth Experimental urethane dimethacylate resin based composite for teeth used with prime and Bond Elect bonding agent	Teeth That Received TPH3 n=42 teeth light-cured resin composite for teeth	Teeth That Received Esthet-X-HD n=41 teeth light cured resin composite for teeth made by Dentsply Caulk
Percent of Teeth With Polish-ability of A, B1 or B2 A	41 teeth	40 teeth	40 teeth
Percent of Teeth With Polish-ability of A, B1 or B2 B1	2 teeth	1 teeth	1 teeth
Percent of Teeth With Polish-ability of A, B1 or B2 B2	1 teeth	1 teeth	0 teeth

Adverse Events

UDMA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TPH3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Esthet-X HD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	UDMA n=50 participants at risk Experimental urethane dimethacrylate resin based composite resin for teeth used with prime an Bond Elect bonding agent	TPH3 n=50 participants at risk Light-cured resin composite for teeth	Esthet-X HD n=35 participants at risk Light cured resin composite for teeth made by Dentsply Caulk
General disorders No response on tooth vitality test	0.00% 0/50 • 24 months	4.0% 2/50 • 24 months	2.9% 1/35 • 24 months

Additional Information

Hans Malmstrom

University of Rochester

Phone: 585-275-5087

Email: hans_malmstrom@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place