A 3-Year Study Comparing New White Resin Crowns to Stainless Steel Crowns for Childrens Baby Molars

What this Trial Is About

Researchers are evaluating a new flexible white dental crown called BioFLX by comparing it to the commonly used flexible metal crown known as the Stainless Steel Crown in children aged 2 to 5 years with cavities that require full coverage restorations. The study aims to see if the new white crown is clinically similar to the silver crown, which is mainly used in pediatric dentistry. Participants will have dental work done under general anesthesia as part of their treatment. Participants will receive crowns on their primary molar teeth using a split-mouth design, where one side of the mouth is randomly assigned to receive the Stainless Steel Crown and the opposite side receives the BioFLX crown. The study will follow participants for up to 36 months to assess the crowns performance using the United States Public Health Service Restorative criteria. Treatment is provided in dental clinics with general anesthesia to control behavioral factors. Throughout the study, participants will have follow-up visits to evaluate the crowns over three years. Researchers will monitor the durability and clinical outcomes of both types of crowns. Participants must be available for these recall visits, and assessments will include dental examinations to measure the success and condition of the crowns. The total duration of participation is up to 36 months, with ongoing monitoring during this period.

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