Clinical trial NCT01919515: Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Official title: Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: pediatric
primary molars
stainless steel crowns
Lead sponsor: NuSmile, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Assessments of the SSC and ZR Crown
timeFrame: At Baseline
measure: Assessments of the SSC and ZR Crown at 6 months
timeFrame: 6 month visit
measure: Assessments of the SSC and ZR Crown at 12 months
timeFrame: 12 month visit
measure: Assessments of the SSC and ZR Crown at 18 months
timeFrame: 18 month visit
measure: Assessments of the SSC and ZR Crown at 24 months
timeFrame: 24 month visit
measure: Assessments of SSC and ZR Crown at 36 months
timeFrame: 36 month visit
measure: Assessments of SSC and ZR Crowns at 48 months
timeFrame: 48 month visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center-Dental School
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
state: Texas
Study officials:
affiliation: University of Texas
name: Kevin J. Donly, D.D.S., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.