Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:52 AM
Study NCT ID:
NCT07357402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars
Sponsor:
PHAM LE ANH THY
Organization:
Study Overview
Official Title:
Comparison of Clinical Outcomes, Parent and Child Satisfaction Between Stainless Steel Crowns and Prefabricated Hybrid (Bioflx) Crowns in Primary Molars
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
The standard treatment for fixing severely decayed baby back teeth is the stainless steel crown, which is a durable metal cap. While these metal crowns work very well, many parents and children prefer a more natural, tooth-colored look. This study tests a newer option called the Bioflx crown, which is made of a flexible, tooth-colored material.
The Treatment Process The crowns are placed during two separate visits, usually 1 to 2 weeks apart. It gives the child time to get used to the first crown and ensures their bite is comfortable before the second one is placed. It makes the appointments shorter and easier for the child to handle. The side of the mouth that gets the metal crown and the side that gets the tooth-colored crown is randomized.
How Success is Measured
After the crowns are placed, researchers will check them again at 3 months and 6 months. They will use professional standards to evaluate the effectiveness of the crowns, focusing on:
1. Durability: Do the crowns stay glued to the teeth and resist wearing down from chewing?
2. Prevention: Does the new material prevent new cavities from forming at the edges of the crown?
3. Gum Health: Do the gums around the tooth stay healthy, or do they become red and swollen?
4. Satisfaction: How do the child and parent feel about the color, size, and shape of the tooth-colored crown compared to the metal one?
The Treatment Process The crowns are placed during two separate visits, usually 1 to 2 weeks apart. It gives the child time to get used to the first crown and ensures their bite is comfortable before the second one is placed. It makes the appointments shorter and easier for the child to handle. The side of the mouth that gets the metal crown and the side that gets the tooth-colored crown is randomized.
How Success is Measured
After the crowns are placed, researchers will check them again at 3 months and 6 months. They will use professional standards to evaluate the effectiveness of the crowns, focusing on:
1. Durability: Do the crowns stay glued to the teeth and resist wearing down from chewing?
2. Prevention: Does the new material prevent new cavities from forming at the edges of the crown?
3. Gum Health: Do the gums around the tooth stay healthy, or do they become red and swollen?
4. Satisfaction: How do the child and parent feel about the color, size, and shape of the tooth-colored crown compared to the metal one?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: