CompletedNot Applicable

Cleaning Methods for Clear Aligners

Saudi Arabia60 participantsStarted 2021-01-17

Plain-language summary

The goal of this clinical trial is to learn which cleaning method best removes bacteria from clear plastic aligners. Clear aligners are removable orthodontic trays worn to straighten teeth. They sit against the teeth for 20 to 22 hours a day. Bacteria build up on their surfaces within days. No agreed-upon way to clean them exists.The main questions it aims to answer are: Which of four common cleaning methods removes the most live bacteria from worn aligners? Which method leaves the least bacteria visible on the aligner surface under a microscope? Researchers will compare four cleaning methods to see which works best: Brushing with water (control) Soaking in chlorhexidine mouthwash Soaking in an effervescent cleaning tablet Using an ultrasonic cleaner together with a cleaning tablet Participants will: Wear one upper and one lower clear aligner for 10 days Clean the upper aligner twice a day for 5 minutes using their assigned method Return the aligner at the end of 10 days for laboratory testing

Who can participate

Age range

18 Years – 35 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: * Adults aged 18 to 35 years * Currently receiving thermoformed clear aligner orthodontic therapy in both the upper and lower arches * Healthy periodontium (no active periodontal disease) * Able and willing to wear assigned upper and lower aligners for 10 days as instructed * Able and willing to perform the assigned cleaning method twice daily for 10 days * Able to provide written informed consent Exclusion Criteria: * Use of any antibiotic within the previous month * Current smoker * Any relevant systemic disease that could affect oral microbial flora or healing * Current use of any oral mouthwash or oral antiseptic product other than the trial product during the 10-day study period

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

Bacterial colony count (CFU/mL) on the fitting surface of the worn upper clear aligner

Timeframe: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)

Trial details

NCT IDNCT07610603

SponsorRiyadh Elm University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-09

View on ClinicalTrials.gov More Orthodontic Appliances, Removable trials