Clinical trial NCT04975321: Clinical Trial NuSmile Crowns
Official title: A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dental Caries, Multisurface Origin (Diagnosis)
Keywords: Anterior primary teeth restorations
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 97
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.

Detailed description: Stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. These crowns are silver in color, and aesthetically are not a good option for restoring front teeth. Several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. With the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: NuSmile Signature crowns, NuSmile ZR crowns, and composite crowns. The investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. The purpose of this pilot study is to evaluate the clinical performance of two types of NuSmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.

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

Primary outcomes:
measure: Fitting
timeFrame: 12 months
measure: Positioning
timeFrame: 12 months
measure: Proximal Contact
timeFrame: 12 months
measure: Marginal Adaptation
timeFrame: 12 months
measure: Color
timeFrame: 12 months
measure: Gingival Status
timeFrame: 12 months
measure: Retention of the Crown
timeFrame: 12 months
measure: Integrity of the Veneer/Composite
timeFrame: 12 months
measure: Secondary Caries
timeFrame: 12 months
measure: History of Trauma
timeFrame: 12 months
measure: Clinical Pulp Pathology
timeFrame: 12 months
measure: Radiographical Pulp Pathology
timeFrame: 12 months
measure: Parent's Esthetic Satisfaction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington-The Center for Pediatric Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Mariella Garcia, DDS
role: PRINCIPAL_INVESTIGATOR
References: