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

Clinical Evaluation of an Experimental Urethane Dimethacrylate Resin Based Composite

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

Study Overview

• Status: Completed
• Conditions: Dental Caries; Restorative Material
• Intervention / Treatment: Device: urethane dimethacrylate; Device: TPH3; Device: Esthet-X HD

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..

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Participants; Participants who needed at least two tooth restorations	Device: urethane dimethacrylate; Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent; Device: TPH3; light-cured resin composite for teeth; Device: Esthet-X HD; light cured resin composite for teeth made by Dentsply Caulk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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	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	24 months

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: restorative material
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antineoplastic Agents; Urethane
• Other Study ID Numbers: 765-552