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Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ZR Crown
Stainless Steel Crown
Sponsored by
NuSmile, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring pediatric, primary molars, stainless steel crowns

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ZR Crown & Stainless Steel Crown

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2013
Last Updated
October 7, 2014
Sponsor
NuSmile, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01919515
Brief Title
Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Official Title
Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuSmile, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
pediatric, primary molars, stainless steel crowns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZR Crown & Stainless Steel Crown
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ZR Crown
Intervention Description
This is an esthetic primary molar crown.
Intervention Type
Device
Intervention Name(s)
Stainless Steel Crown
Intervention Description
This is a conventional stainless steel crown.
Primary Outcome Measure Information:
Title
Assessments of the SSC and ZR Crown
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.
Time Frame
At Baseline
Title
Assessments of the SSC and ZR Crown at 6 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
6 month visit
Title
Assessments of the SSC and ZR Crown at 12 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
12 month visit
Title
Assessments of the SSC and ZR Crown at 18 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
18 month visit
Title
Assessments of the SSC and ZR Crown at 24 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
24 month visit
Title
Assessments of SSC and ZR Crown at 36 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
36 month visit
Title
Assessments of SSC and ZR Crowns at 48 months
Description
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Time Frame
48 month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J. Donly, D.D.S., M.S.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center-Dental School
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The University of Texas Health Science Center-Ricardo Salinas Dental Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78237
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14121956
Citation
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.
Results Reference
background
PubMed Identifier
6935165
Citation
Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
Results Reference
background

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Trial of a New NuSmile ZR Esthetic Primary Molar Crown

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