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

Primary Purpose

Dental Caries, Restorative Material

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
urethane dimethacrylate
TPH3
Esthet-X HD
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring restorative material

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester, Eastman Institute for Oral Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

Participants who needed at least two tooth restorations

Outcomes

Primary Outcome Measures

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.
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.
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
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2013
Last Updated
July 30, 2018
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT02018822
Brief Title
Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material
Official Title
Clinical Evaluation of an Experimental Urethane Dimethacrylate Resin Based Composite
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Restorative Material
Keywords
restorative material

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
Participants who needed at least two tooth restorations
Intervention Type
Device
Intervention Name(s)
urethane dimethacrylate
Intervention Description
Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent
Intervention Type
Device
Intervention Name(s)
TPH3
Intervention Description
light-cured resin composite for teeth
Intervention Type
Device
Intervention Name(s)
Esthet-X HD
Intervention Description
light cured resin composite for teeth made by Dentsply Caulk
Primary Outcome Measure Information:
Title
Percent of Teeth With Anatomic Form Graded as A or B.
Description
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
Title
Percent of Teeth Scored as A or B for Color Match
Description
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
Title
Percent of Teeth With Marginal Integrity Graded A, B1 and B2
Description
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
Title
Percent of Teeth With Marginal Discoloration of A or B
Description
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
Title
Percent of Teeth With Proximal Contact
Description
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
Title
Percent of Teeth With Polish-ability of A, B1 or B2
Description
A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rochester, Eastman Institute for Oral Health
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

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

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