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

ConditionDental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

Qualifiers

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.

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 venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.

Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.

Disqualifiers

Participants who do not meet inclusion criteria will be excluded.

Participants whose teeth do not meet the inclusion criteria.

Participants who do not wish to participate in the study.

Patients who do not wish to or cannot reliably return for follow-up visits.

Trial design

Treatments tested in this trial

  • BioFLX crown
  • 3M Stainless Steel Crown

Treatment groups

50 Participants
are divided into 2 treatment groups