Trial of a New NuSmile ZR Esthetic Primary Molar Crown

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Device: ZR Crown; Device: Stainless Steel Crown

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center-Dental School
    • San Antonio, Texas, United States, 78237
      • The University of Texas Health Science Center-Ricardo Salinas Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: ZR Crown; This is an esthetic primary molar crown.; Device: Stainless Steel Crown; This is a conventional stainless steel crown.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Baseline
Assessments of the SSC and ZR Crown at 6 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	6 month visit
Assessments of the SSC and ZR Crown at 12 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	12 month visit
Assessments of the SSC and ZR Crown at 18 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	18 month visit
Assessments of the SSC and ZR Crown at 24 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	24 month visit
Assessments of SSC and ZR Crown at 36 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	36 month visit
Assessments of SSC and ZR Crowns at 48 months	Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.	48 month visit

Collaborators and Investigators

• Sponsor: NuSmile, Ltd.
• Investigators: Principal Investigator: Kevin J. Donly, D.D.S., M.S., University of Texas

Publications and helpful links

General Publications

• 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.
• Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: pediatric; primary molars; stainless steel crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 20130203