3D-Printed Vs Thermoformed Retainers: Comparison of Post-Treatment Stability, Changes in Mechanic… (NCT05968625) | Clinical Trial Compass
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3D-Printed Vs Thermoformed Retainers: Comparison of Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL
Malaysia30 participantsStarted 2023-03-28
Plain-language summary
Following completion of orthodontic treatment, prolonged retention with either part-time or full-time wear of retainers is crucial in preventing relapse. Clear thermoformed retainers (TFR) are easy to fabricate and popular among orthodontic patients. With the advent of digital orthodontics and the development of biocompatible photopolymerizable resin, it is now possible to fabricate direct 3D-printed retainers.
The aim of this study is to determine and compare the post-treatment stability of dentition, changes in thickness and mechanical properties of the retainers, and oral health-related quality of life (OHRQoL) of patients wearing direct 3D-printed retainers and conventional thermoformed retainers over a retention period of 6 months.
Who can participate
Age range
18 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:
* Fixed appliance treatment in both arches and indicated for VFR in the retention phase as part of their original treatment plan.
* No intention to relocate within the study period; able to attend the three-monthly review appointments for half a year.
Exclusion Criteria:
* Single-arch or sectional fixed appliances.
* Space dentition.
* Hypodontia requiring tooth replacement on the retainer as a temporary measure.
* Previous treatment with maxillary expansion.
* Indicated for fixed retainer or double retention regime (such as VFRs fitted over fixed retainers).
* Premature debond from the original fixed appliances course.
* Cleft lip and/or palate; or orthognathic cases.
* Learning difficulties and inability to read written instructions/ questionnaire in English or Malay
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.