Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZR Crown & Stainless Steel Crown

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.

Group Type OTHER

ZR Crown

Intervention Type DEVICE

This is an esthetic primary molar crown.

Stainless Steel Crown

Intervention Type DEVICE

This is a conventional stainless steel crown.

Interventions

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ZR Crown

This is an esthetic primary molar crown.

Intervention Type DEVICE

Stainless Steel Crown

This is a conventional stainless steel crown.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No