A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
Children's Hospital Medical Center, Cincinnati
Summary
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.
Eligibility
- Age range
- 2–5 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation. * Patients who speak the most common languages at CCHMC will be able to be recruited for the study. o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French. * These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a…
Interventions
- DeviceBioFLX crown
Device: BioFLX crown
- Device3M Stainless Steel Crown
3M Stainless Steel Crown
Location
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio