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Trial of a New NuSmile ZR Esthetic Primary Molar Crown

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NuSmile, Ltd.
ClinicalTrials.gov Identifier:
NCT01919515
First received: July 31, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.


Condition Intervention
Dental Caries
Device: ZR Crown
Device: Stainless Steel Crown

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Resource links provided by NLM:


Further study details as provided by NuSmile, Ltd.:

Primary Outcome Measures:
  • Assessments of the SSC and ZR Crown [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.

  • Assessments of the SSC and ZR Crown at 6 months [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

  • Assessments of the SSC and ZR Crown at 12 months [ Time Frame: 12 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

  • Assessments of the SSC and ZR Crown at 18 months [ Time Frame: 18 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

  • Assessments of the SSC and ZR Crown at 24 months [ Time Frame: 24 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

  • Assessments of SSC and ZR Crown at 36 months [ Time Frame: 36 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

  • Assessments of SSC and ZR Crowns at 48 months [ Time Frame: 48 month visit ] [ Designated as safety issue: No ]
    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ZR Crown & Stainless Steel Crown
Each subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown.
Device: ZR Crown
This is an esthetic primary molar crown.
Device: Stainless Steel Crown
This is a conventional stainless steel crown.

Detailed Description:

The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be between 3 and 7 years of age
  • Have a minimum of two primary molar teeth, requiring crowns
  • Have a parent or guardian capable of giving written informed consent
  • Have study teeth in occlusion and in contact with adjacent teeth
  • Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.

Exclusion Criteria:

  • Tooth is considered to be within 36 months of exfoliation
  • They have a severe / serious childhood illness that requires frequent hospitalization
  • They have poor general health
  • They have juvenile periodontitis
  • Patient is unable to return for evaluations / study recalls
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919515

Locations
United States, Texas
The University of Texas Health Science Center-Dental School
San Antonio, Texas, United States, 78229
The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
San Antonio, Texas, United States, 78237
Sponsors and Collaborators
NuSmile, Ltd.
Investigators
Principal Investigator: Kevin J. Donly, D.D.S., M.S. University of Texas
  More Information

Publications:
Responsible Party: NuSmile, Ltd.
ClinicalTrials.gov Identifier: NCT01919515     History of Changes
Other Study ID Numbers: 20130203
Study First Received: July 31, 2013
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NuSmile, Ltd.:
pediatric
primary molars
stainless steel crowns

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014