Clinical Trial NuSmile Crowns

University of Washington

Status: Completed

Conditions: Primary Dental Caries, Multisurface Origin (Diagnosis)

Treatments: Device: Composite strip crown; Device: Nu Smile Pre Veneered crown; Device: Nu Smile Zirconia crown

Study type: Interventional

Funder types: Other

Identifiers

NCT04975321

STUDY00003980

Details and patient eligibility

About

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

Full 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.

Enrollment: 97 patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

Nu Smile Zirconia crown

Active Comparator group

Description:

Anterior primary teeth which received a NuSmile zirconia crown as a final restoration

Treatment:

Device: Nu Smile Zirconia crown

Nu Smile pre veneered crown

Active Comparator group

Description:

Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration

Treatment:

Device: Nu Smile Pre Veneered crown

Composite strip crown

Active Comparator group

Description:

Anterior primary teeth which received a composite strip crown as a final restoration

Treatment:

Device: Composite strip crown