An interventional study of BioFLX crown and 3M Stainless Steel Crown in Dental Caries, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.
Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16
o Teeth With
Exclusion Criteria:
Participants who do not meet inclusion criteria will be excluded.
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.
Device: 3M Stainless Steel 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.
Device: BioFLX crown
Device: BioFLX crown
3M Stainless Steel Crown
The United States Public Health Service Restorative criteria
Study criteria being selected would be: Gingival Health, Plaque retention, Occlusal wear, and crown retention as defined by the following Alpha, Bravo, Charlie. Gingival Health according to the Modified Gingival Index (MGI): Alpha (A) normal gingiva Bravo (B) mild inflammation: Charlie (C) moderate inflammation Plaque Retention according to the Simplified Oral Hygiene Index (OHI -S): Alpha (A) 0, 1 Bravo (B)2 Charlie (C) 3 Occlusal Wear: Alpha (A) occlusal surface intact Bravo (B) wear of occlusal surface without tooth surface exposure Charlie (C) wear of occlusal surface with tooth surface exposure. Crown retention: Alpha (A) Intact crown Bravo (B) partial loss of crown material Charlie (C) Crown lost
Time frame: 36 months
Plan to share: No — It can be if needed
No publications or documents are linked to this record.
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Children's Hospital Medical Center, Cincinnati