Dental CariesNCT02018822

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

A study testing urethane dimethacrylate, TPH3 and Esthet-X HD in people with Dental Caries and Restorative Material, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries, Restorative Material
What is being tested?: urethane dimethacrylate, TPH3 and Esthet-X HD
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester, Eastman Institute for Oral Health
Rochester, New York, 14620

Other trials in United States

About this study

Official title: Clinical Evaluation of an Experimental Urethane Dimethacrylate Resin Based Composite

Read the 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..

Conditions: Dental Caries, Restorative Material
Being tested: urethane dimethacrylate, TPH3, Esthet-X HD
Keywords: restorative material
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

urethane dimethacrylateDevice
Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent
TPH3Device
light-cured resin composite for teeth
Esthet-X HDDevice
light cured resin composite for teeth made by Dentsply Caulk

Study groups in NCT02018822
Study group	Role	What they receive
All Participants	Experimental	Participants who needed at least two tooth restorations Receives: Device: urethane dimethacrylate; Device: TPH3; Device: Esthet-X HD

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Sep 2017

First posted23 Dec 2013 (estimated)
Study startJun 2013
Primary completion29 Jun 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental CariesStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02018822
Sponsor's protocol ID: 765-552
Status last verified: Jul 2018
First submitted: 17 Dec 2013
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of an Experimental Urethane Dimethacrylate Resin Based Composite
ClinicalTrials.gov ID: NCT02018822
Acronym / sponsor ID: 765-552
Conditions: Dental Caries, Restorative Material
Keywords: restorative material
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: Jun 2013
Primary completion: 29 Jun 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 23 Dec 2013 (estimated)
Results: Posted 28 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
All Participants	Experimental	Device: urethane dimethacrylate, Device: TPH3, Device: Esthet-X HDParticipants who needed at least two tooth restorations

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
urethane dimethacrylateExperimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent	Device	All Participants
TPH3light-cured resin composite for teeth	Device	All Participants
Esthet-X HDlight cured resin composite for teeth made by Dentsply Caulk	Device	All Participants

Primary outcome

Percent of Teeth With Anatomic Form Graded as A or B.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months
A= Smooth \& highly shiny, similar to enamel B1= Smooth \& satin, highly reflective B2= Smooth \& shiny but not highly reflective

Results and safety

Results posted to the registry on 28 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UDMA	50	44
TPH3	50	42
Esthet-X	35	29

Primary outcome: Percent of Teeth With Anatomic Form Graded as A or B.

Time frame: 24 months. Count of units. Unit: teeth

Measure	Teeth That Received UDMA n = 44	Teeth That Received TPH3 n = 42	Teeth That Received Esthet-X-HD n = 29
A	42	37	40
B	2	5	1

Teeth That Received UDMA vs Teeth That Received TPH3 vs Teeth That Received Esthet-X-HD: p = 0.2552, Chi-squared

Population analysed: 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.

Primary outcome: Percent of Teeth Scored as A or B for Color Match

Time frame: 24 months. Count of units. Unit: teeth

Measure	UDMA n = 44	TPH3 n = 42	Participants That Completed Esthet-X Intervention n = 29
A	41	40	40
B	3	2	1

UDMA vs TPH3 vs Participants That Completed Esthet-X Intervention: p = 0.2235, Chi-squared

Population analysed: 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.

Primary outcome: Percent of Teeth With Marginal Integrity Graded A, B1 and B2

Time frame: 24 months. Count of units. Unit: teeth

Measure	Teeth That Received UDMA n = 44	Teeth That Received TPH3 n = 42	Teeth That Received Esthet-X-HD n = 29
A	39	36	39
B1	2	4	1
B2	3	2	1

Teeth That Received UDMA vs Teeth That Received TPH3 vs Teeth That Received Esthet-X-HD: p = 0.3891, Chi-squared

Population analysed: 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.

Primary outcome: Percent of Teeth With Marginal Discoloration of A or B

Time frame: 24 months. Count of units. Unit: teeth

Measure	Teeth That Received UDMA n = 44	Teeth That Received TPH3 n = 42	Teeth That Received Esthet-X-HD n = 29
A	39	40	39
B	5	2	2

Teeth That Received UDMA vs Teeth That Received TPH3 vs Teeth That Received Esthet-X-HD: p = 0.3883, Chi-squared

Population analysed: 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.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UDMA	0 of 50 (0%)	0 of 50 (0%)	0 of 50
TPH3	0 of 50 (0%)	2 of 50 (4%)	0 of 50
Esthet-X HD	0 of 35 (0%)	1 of 35 (2.9%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing urethane dimethacrylate, TPH3 and Esthet-X HD in people with Dental Caries and Restorative Material, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Teeth With Anatomic Form Graded as A or B. (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.