Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth (NCT06713330)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. 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.
3. 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.
4. Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.
5. For example, tooth A \& J, B \& I, S \& L, or T \& K
6. For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study.
7. Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16 o Teeth With
8. Extensive caries
9. Cervical decalcification
10. Developmental defects (e.g., hypoplasia, hypocalcification)
11. When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)
12. Following pulpotomy or pulpectomy

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.