N/A
N=76
Clinical Trial NuSmile Crowns
Primary Dental Caries, Multisurface Origin (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT04975321 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Fitting — 37; 42; 48; 3 Teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nu Smile Zirconia crown (Device); Nu Smile Pre Veneered crown (Device); Composite strip crown (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fitting |
37; 42; 48; 3; 5; 0 | — |
| PRIMARY Positioning |
40; 45; 46; 0; 2; 2 | — |
| PRIMARY Proximal Contact |
30; 41; 44; 9; 6; 4 | — |
| PRIMARY Marginal Adaptation |
40; 47; 43; 0; 0; 5 | — |
| PRIMARY Color |
40; 47; 48; 0; 0; 0 | — |
| PRIMARY Gingival Status |
9; 5; 0; 8; 18; 14 | — |
| PRIMARY Retention of the Crown |
40; 47; 48; 0; 0; 0 | — |
| PRIMARY Integrity of the Veneer/Composite |
40; 47; 47; 0; 0; 1 | — |
| PRIMARY Secondary Caries |
39; 43; 42; 1; 4; 6 | — |
| PRIMARY History of Trauma |
39; 38; 47; 1; 9; 1 | — |
| PRIMARY Clinical Pulp Pathology |
39; 47; 47; 1; 0; 1 | — |
| PRIMARY Radiographical Pulp Pathology |
37; 43; 48; 3; 4; 0 | — |
| PRIMARY Parent's Esthetic Satisfaction |
38; 47; 48; 2; 0; 0 | — |
Summary
A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.
Eligibility Criteria
Inclusion Criteria
- Patients of record at the University of Washington's Center for Pediatric Dentistry
- Patients in general good health (ASA I)
- Patients aged 5 years old or younger
- Patients in need of at least one preformed crowns, on anterior primary teeth
- Patients undergoing general anesthesia for dental treatment
- Parent or guardian of patient able and willing to provide informed consent
Exclusion Criteria
- Medically compromising condition
- Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
- Teeth with complete absence of facial or lingual walls following tooth preparation
- Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
- Anterior crowding
- Occlusion class III
Data sourced from ClinicalTrials.gov (NCT04975321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.