Overview

This trial is active, not recruiting.

Condition dental caries
Treatments zr crown, stainless steel crown
Sponsor NuSmile, Ltd.
Start date April 2013
End date June 2017
Trial size 50 participants
Trial identifier NCT01919515, 20130203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
zr crown
This is an esthetic primary molar crown.
stainless steel crown
This is a conventional stainless steel crown.

Primary Outcomes

Measure
Assessments of the SSC and ZR Crown
time frame: At Baseline
Assessments of the SSC and ZR Crown at 6 months
time frame: 6 month visit
Assessments of the SSC and ZR Crown at 12 months
time frame: 12 month visit
Assessments of the SSC and ZR Crown at 18 months
time frame: 18 month visit
Assessments of the SSC and ZR Crown at 24 months
time frame: 24 month visit
Assessments of SSC and ZR Crown at 36 months
time frame: 36 month visit
Assessments of SSC and ZR Crowns at 48 months
time frame: 48 month visit

Eligibility Criteria

Male or female participants from 3 years up to 7 years old.

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

Additional Information

Official title Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Principal investigator Kevin J. Donly, D.D.S., M.S.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by NuSmile, Ltd..