NCT01919515

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

4.2 years

First QC Date

July 31, 2013

Last Update Submit

October 7, 2014

Conditions

Dental Caries

Keywords

pediatricprimary molarsstainless steel crowns

Outcome Measures

Primary Outcomes (7)

  • Assessments of the SSC and ZR Crown

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.

    At Baseline

  • Assessments of the SSC and ZR Crown at 6 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    6 month visit

  • Assessments of the SSC and ZR Crown at 12 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    12 month visit

  • Assessments of the SSC and ZR Crown at 18 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    18 month visit

  • Assessments of the SSC and ZR Crown at 24 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    24 month visit

  • Assessments of SSC and ZR Crown at 36 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    36 month visit

  • Assessments of SSC and ZR Crowns at 48 months

    Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.

    48 month visit

Study Arms (1)

ZR Crown & Stainless Steel Crown

OTHER

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 CrownDevice: Stainless Steel Crown

Interventions

ZR CrownDEVICE

This is an esthetic primary molar crown.

ZR Crown & Stainless Steel Crown
Stainless Steel CrownDEVICE

This is a conventional stainless steel crown.

ZR Crown & Stainless Steel Crown

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Texas Health Science Center-Dental School

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center-Ricardo Salinas Dental Clinic

San Antonio, Texas, 78237, United States

Location

Related Publications (2)

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956BACKGROUND

  • Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.

    PMID: 6935165BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Kevin J. Donly, D.D.S., M.S.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 9, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2017

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

US(2)