Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
NCT Number: NCT06713330
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.
Interested in participating?
Request Info2 year–5 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
o Teeth With
Exclusion criteria
Device: BioFLX crown
3M Stainless Steel Crown
Time frame: 36 months
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
Contact information is provided by the study sponsor or research team.
Children's Hospital Medical Center, Cincinnati
Other
A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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