Actively Recruiting
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-12-10
50
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years to 5 years 11 months who are patients at CCHMC pediatric dental clinics
- Children needing full mouth dental rehabilitation under general anesthesia at CCHMC
- Children who speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, or French
- Candidates for treatment in the CCHMC dental in-office general anesthesia area or Procedure Center
- At least one pair of matching primary molars in the same arch needing full coverage restoration
- Teeth showing extensive caries, cervical decalcification, developmental defects, or likely failure of other materials
- Teeth needing treatment following pulpotomy or pulpectomy
- Children at high caries risk as defined by AAPD Best Practice Guidelines
- Children able to attend follow-up recall appointments
- Children classified as ASA I or ASA II by the American Society of Anesthesiologists
You will not qualify if you...
- Teeth that do not meet the inclusion criteria
- Children who do not wish to participate in the study
- Children unable or unwilling to reliably attend follow-up visits
- Allergy to red dye preventing plaque disclosure during follow-up
- Children who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, or French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
P
Patrick Ruck, DDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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