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

NCT02018822 | Completed Results

• 1 other identifier: 765-552
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries; Restorative Material

Keywords

restorative material

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

All Participants

EXPERIMENTAL

Participants who needed at least two tooth restorations

Device: urethane dimethacrylate; Device: TPH3; Device: Esthet-X HD

Interventions

urethane dimethacrylate DEVICE

Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent

All Participants

TPH3 DEVICE

light-cured resin composite for teeth

All Participants

Esthet-X HD DEVICE

light cured resin composite for teeth made by Dentsply Caulk

All Participants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % of the restorations must be Class II
• all restorations must have at least one occlusal contact in habitual closure

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester, Eastman Institute for Oral Health

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Hans Malmstrom
• Organization: University of Rochester

hans_malmstrom@urmc.rochester.edu

585-275-5087

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: June 1, 2013
• Primary Completion: June 29, 2017
• Study Completion: September 1, 2017
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-07

Locations

US (1)