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

NCT07357402 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Severely Decayed Primary Molars Requiring Full-Coverage Crowns

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

Sponsors & Collaborators

  • PHAM LE ANH THY

    lead OTHER

Principal Investigators

  • Huong Thi Nguyen Nguyen, PhD · Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-07-01
Completion
2027-10-01
FDA Device
Yes

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357402 on ClinicalTrials.gov