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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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stainless steel crown | Active Comparator | Participants receive a prefabricated stainless steel crown placed on a primary molar according to standard pediatric dental procedures. The crown is selected, adapted, and cemented following conventional clinical protocols and serves as the standard treatment comparator in this study. |
|
| Bioflx crown | Experimental | Participants receive a prefabricated Bioflx crown placed on a primary molar using manufacturer-recommended techniques. The crown is selected and cemented following standardized clinical procedures and is evaluated as the experimental intervention for clinical performance and patient-related outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stainless Steel Crown | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| - Clincal outcomes: crown stability; bite discomfort; fit and color changes at the crown edge; crown shape; crown retention; crown wear; wear of the opposing tooth or crown - Oral hygiene and gum health around the crowns |
| - Crown stability, bite discomfort, fit and color at the crown margin, and crown shape were checked after crown placement, at 3 months, and at 6 months follow-up visits. Others were checked at 3, 6 months, except secondary caries was checked at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| parent and child satisfaction |
|
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Inclusion Criteria:
Children with at least two carious primary molars located on both the right and left sides of the dental arch and indicated for crown placement
Children and their parents have ability to communicate in Vietnamese
Primary molars indicated for full-coverage crown restoration, including teeth with:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huong Thi Nguyen Nguyen, PhD | Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam | |||
| University of Medicine and Pharmacy at Ho Chi Minh City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41126408 | Background | Tin BT, Phuong NTM, Anh NTH, Bau TH, Dong TT, Ngoc VTN. Short-Term Clinical Evaluation of Bioflx Crowns for Primary Molar Restoration in Children Aged 4-8 Years in Vietnam: A Pilot Observational Study. Int J Paediatr Dent. 2026 Jan;36(1):187-194. doi: 10.1111/ipd.70039. Epub 2025 Oct 22. | |
| 32509626 | Background |
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The study is designed as a randomized split-mouth clinical trial. Each child will receive both types of crowns on two similar teeth on opposite sides of the mouth. One side is randomly assigned to receive a stainless steel crown, and the other side receives a Bioflx crown. The placement of the two crowns is performed in two separate appointments, with an interval of 1 to 2 weeks between them. This approach allows the child to adapt to the new occlusion (bite) after the first crown is placed, ensuring a more stable result before the second procedure.
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| Bioflx crown | Device | Bioflx crowns are prefabricated tooth-colored polymer crowns designed to improve esthetics compared with conventional stainless steel crowns |
|
| From immediately after crowns placement through the 3-month and 6-month follow-up visits. |
| Ho Chi Minh City |
| Vietnam |
| Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar. |
| 31445509 | Background | Lopez-Cazaux S, Aiem E, Velly AM, Muller-Bolla M. Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial. Trials. 2019 Aug 24;20(1):530. doi: 10.1186/s13063-019-3559-1. |
| 28494606 | Background | Pozos-Guillen A, Chavarria-Bolanos D, Garrocho-Rangel A. Split-mouth design in Paediatric Dentistry clinical trials. Eur J Paediatr Dent. 2017 Mar;18(1):61-65. doi: 10.23804/ejpd.2017.18.01.13. |
| 38616425 | Background | Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15. |