CompletedNot Applicable

Microbial Colonization in Three Dimensional (3D) Printed Orthodontic Clear Aligners

United States30 participantsStarted 2025-09-02

Plain-language summary

This study is being done to compare conventional clear aligners with 3D printed clear aligners to assess if there is any significant difference between the microbial colonization of these appliances. The 3D printed aligner material and conventional aligner materials are being used for investigational purposes and have been approved for their use in fabricating clear aligners for orthodontic tooth movement, but not for the purposes of our study, which is for the fabrication of clear passive aligners to assess microbial colonization.

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: * Participants are in the permanent dentition * Participants can understand written English instructions * Participants have no history of smoking * Participants will not undergo any active orthodontic treatment. Exclusion Criteria: * Periodontal disease/gingivitis or craniofacial anomalies. * Severe tooth crowding

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

Microbial colonization of the tooth surface

Timeframe: 1 week Immediately following aligner wear

Microbial composition of inner surface biofilm of aligners

Timeframe: 1 week Immediately following aligner wear

Trial details

NCT IDNCT07143370

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-17

View on ClinicalTrials.gov More Orthodontic Aligner trials