Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars

The goal of this clinical trial is to learn if the Bioflx crown (a tooth-colored material) is as effective as the standard stainless steel crown for treating severely decayed baby back teeth in children aged 4 to 10 years old. The study also aims to evaluate parent and child satisfaction with these restorative options. The main questions it aims to answer are: 1. Is the Bioflx crown as effective as the stainless steel crown in terms of durability, staying in place, and protecting the tooth from new decay? 2. Does the Bioflx crown maintain better gum health and cause less wear on the opposing teeth compared to the stainless steel crown? Researchers will compare the Bioflx crown to the stainless steel crown to see which material works better to restore tooth function and health. Participants will: 1. Receive one Bioflx crown and one stainless steel crown on similar teeth on opposite sides of the mouth. 2. Visit the clinic for two separate appointments, spaced 1 to 2 weeks apart, to have the crowns placed. 3. Return for checkups at 3 months and 6 months so researchers can examine the health of the teeth and gums. 4. Answer questions about how happy they are with the appearance and feel of the crowns.

NCT Number	NCT07357402
Lead Sponsor	PHAM LE ANH THY
Conditions	Severely Decayed Primary Molars Requiring Full-Coverage Crowns
Enrollment	25 participants
Start Date	2025-08-01
Primary Completion	2026-07-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-22