Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Dental Caries Clinical Trial

Official title:

Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01919515
• Other study ID #: 20130203
• Status: Active, not recruiting
• Phase: N/A
• First received: July 31, 2013
• Last updated: October 7, 2014
• Start date: April 2013

Study information

• Verified date: October 2014
• Source: NuSmile, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• ZR Crown
This is an esthetic primary molar crown.
• Stainless Steel Crown
This is a conventional stainless steel crown.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
NuSmile, Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (2)

LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No