Status:
UNKNOWN
Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Lead Sponsor:
NuSmile, Ltd.
Conditions:
Dental Caries
Eligibility:
All Genders
3-7 years
Phase:
NA
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.
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01919515
Start Date
April 1 2013
Last Update
October 8 2014
Active Locations (2)
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1
The University of Texas Health Science Center-Dental School
San Antonio, Texas, United States, 78229
2
The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
San Antonio, Texas, United States, 78237