Clinical Research Directory

3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.

Sponsor: Murad Alrashidi

Summary

Purpose of the Study When a child loses a "baby" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer. This study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide. The Three Study Groups Children in this study are randomly assigned to one of three groups: 1. 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material. 2. Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place. 3. Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit. What is Being Measured? Researchers are following the children for 12 months to track: Survival: Which appliance stays glued in and doesn't break most effectively? Time: How much time does the dentist spend making and fitting the appliance? Comfort: How much discomfort or pain did the child feel during the process? Health: Does the appliance cause any irritation to the gums or surrounding teeth? Who Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile. Importance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.

Official title: 3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol

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