Trial of a New NuSmile ZR Esthetic Primary Molar Crown
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 3 - 7 |
| Updated: | 11/8/2014 |
| Start Date: | April 2013 |
Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
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.
similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of
primary molar teeth.
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.
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.
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
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