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Dental Restoration
ZR vs Stainless Steel Crowns for Tooth Decay
N/A
Waitlist Available
Led By Kevin J. Donly, D.D.S., M.S.
Research Sponsored by NuSmile, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a minimum of two primary molar teeth, requiring crowns
Have study teeth in occlusion and in contact with adjacent teeth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 month visit
Awards & highlights
Study Summary
This trial will compare how well NuSmile ZR esthetic primary molar crowns and Stainless Steel primary molar crowns restore primary molar teeth.
Who is the study for?
This trial is for children aged 3 to 7 who need crowns on at least two primary molar teeth. They must have enough tooth tissue left for the crown and a parent or guardian who can consent. Kids close to losing their baby teeth, with poor health, gum disease, or severe illness requiring hospital stays cannot join.Check my eligibility
What is being tested?
The study compares NuSmile ZR esthetic crowns with traditional Stainless Steel crowns for kids' primary molars. It aims to see if the new ZR crowns work as well as the steel ones in restoring decayed teeth.See study design
What are the potential side effects?
While specific side effects are not listed, dental procedures may cause discomfort, swelling, sensitivity in the treated area, and potential issues with bite alignment that might require adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need crowns for at least two of my primary molar teeth.
Select...
My teeth align properly and touch the ones next to them.
Select...
My teeth have enough healthy tissue for a NuSmile ZR crown.
Select...
I am between 3 and 7 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 month visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 month visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessments of SSC and ZR Crown at 36 months
Assessments of SSC and ZR Crowns at 48 months
Assessments of the SSC and ZR Crown
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ZR Crown & Stainless Steel CrownExperimental Treatment2 Interventions
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.
Find a Location
Who is running the clinical trial?
NuSmile, Ltd.Lead Sponsor
Kevin J. Donly, D.D.S., M.S.Principal InvestigatorUniversity of Texas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot come back for follow-up visits.I am between 3 and 7 years old.My tooth is expected to fall out within the next 3 years.I have been diagnosed with juvenile periodontitis.I need crowns for at least two of my primary molar teeth.My teeth align properly and touch the ones next to them.My teeth have enough healthy tissue for a NuSmile ZR crown.
Research Study Groups:
This trial has the following groups:- Group 1: ZR Crown & Stainless Steel Crown
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will individuals who are 50 years or older be able to participate in this research?
"Children aged 3 to 7 can participate in this clinical trial, which is one of 57 studies currently recruiting for people under 18. For those over 65, there are 30 different trials."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center-Dental School
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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