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ACTIVE NOT RECRUITING
NCT07357402
NA

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

Sponsor: PHAM LE ANH THY

View on ClinicalTrials.gov

Summary

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.

Official title: Comparison of Clinical Outcomes, Parent and Child Satisfaction Between Stainless Steel Crowns and Prefabricated Hybrid (Bioflx) Crowns in Primary Molars

Key Details

Gender

All

Age Range

4 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-08-01

Completion Date

2027-10-01

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DEVICE

Stainless Steel Crown

Stainless steel crowns are prefabricated metal crowns that have been widely and long used in pediatric dentistry to restore primary molars with extensive caries or following pulp therapy.

DEVICE

Bioflx crown

Bioflx crowns are prefabricated tooth-colored polymer crowns designed to improve esthetics compared with conventional stainless steel crowns

Locations (2)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam