Evaluation of a 3D Printed Space Maintainer Versus the Conventional Band and Loop (NCT07161076) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of a 3D Printed Space Maintainer Versus the Conventional Band and Loop
Egypt13 participantsStarted 2024-05-01
Plain-language summary
The goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are:
1. What is the clinical success rate of 3D printed space maintainers compared to traditional metal band and loop space maintainers over a 12-month period?
2. How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth?
3. What are the differences in gingival health outcomes between the two types of space maintainers?
Participants (13 children aged 6-9 years) will:
Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group).
Attend checkups every 3 months for a year to monitor the devices' performance.
Who can participate
Age range
6 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Apparently healthy children.
. Children of both genders aged 6-9 years old.
. Guardians agree to join the study and sign the informed consent.
. Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.
. Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).
. Good oral hygiene.
. Absence of radiographic periapical pathology related to the abutment teeth.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Success Rate of Space Maintainers
Timeframe: 12 months
2
Gingival health index
Timeframe: at 3-month follow-up, 6 months follow-up , and 1 year follow-up