Trial of a New NuSmile ZR Esthetic Primary Molar Crown

NuSmile

Status

Unknown

Conditions

Dental Caries

Treatments

Device: Stainless Steel Crown

Device: ZR Crown

Study type

Interventional

Funder types

Industry

Identifiers

NCT01919515

20130203

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

3 to 7 years old

Volunteers

No Healthy Volunteers

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