Trial of a New NuSmile ZR Esthetic Primary Molar Crown

N/AUnknownNCT01919515

NuSmile, Ltd.50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Caries

Interventions

ZR CrownDEVICE

This is an esthetic primary molar crown.

Stainless Steel CrownDEVICE

This is a conventional stainless steel crown.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (2)

The University of Texas Health Science Center-Dental School

San Antonio, Texas, United States

The University of Texas Health Science Center-Ricardo Salinas Dental Clinic

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Assessments of the SSC and ZR Crown

Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.

Time frame: At Baseline

Assessments of the SSC and ZR Crown at 6 months