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Completed

NCT Number: NCT02018822

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

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

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Key information

Conditions

Dental Caries Restorative Material Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester, Eastman Institute for Oral Health

Rochester, New York, 14620, United States

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urethane dimethacrylate

Device

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

TPH3

Device

light-cured resin composite for teeth

Esthet-X HD

Device

light cured resin composite for teeth made by Dentsply Caulk

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Clinical Evaluation of an Experimental Urethane Dimethacrylate Resin Based Composite

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2013
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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