Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06713330
Status
Recruiting
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Conditions

  • Dental Caries

Eligibility Criteria

Sex
ALL
Age
2 Years - 5 Years
Healthy Volunteers
Accepted

Interventions

  • BioFLX crown — DEVICE
    Device: BioFLX crown
  • 3M Stainless Steel Crown — DEVICE
    3M Stainless Steel Crown

Study Details

The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.

Key Dates

First listed
Dec 3, 2024
Start date
May 17, 2024
Status verified
Jun 2026
Primary completion
Dec 29, 2027
Completion
Dec 29, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: SSC
    Experimental: 3M Stainless Steel Crowns. In this split-mouth design, subjects were randomly assigned to receive SSC in the left or right side of the mouth.
  • Experimental: BioFLX Crown
    Experimental: BioFLX Crowns. In this split-mouth design, subjects were randomly assigned to receive BioFLX crowns on the side opposite of the 3M Stainless Steel Crowns.

Primary Outcome Measure

The United States Public Health Service Restorative criteria [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Patrick T Ruck
[email protected]
757-560-2623

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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