Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cleaning Methods for Clear Aligners
Sponsor: Riyadh Elm University
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
Official title: Bacterial Biofilm Evaluation of Four Methods for Cleaning Clear Aligners Using SEM: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-01-17
Completion Date
2021-03-09
Last Updated
2026-05-29
Healthy Volunteers
Yes
Conditions
Interventions
Toothbrushing of clear aligner with water
Mechanical cleaning of the upper clear aligner using a soft manual toothbrush and running tap water at room temperature. Cleaning is performed by the participant twice daily for 5 minutes per session, over a 10-day aligner cycle. No chemical agent, no ultrasonic device. This intervention serves as the comparator for the chemical and combined-cleaning regimens. The same brand of soft manual toothbrush is provided to all participants in the trial.
Chlorhexidine gluconate 0.2% oral rinse
Aqueous oral antiseptic solution containing 0.2% chlorhexidine gluconate used as a soaking solution for the upper clear aligner (not as a mouth rinse for the participant). After toothbrushing the aligner, the participant immerses it in 10 mL of 0.2% chlorhexidine gluconate for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Chlorhexidine is used in this study as a device cleaning agent applied to the aligner surface, not as a therapeutic mouthwash administered to the participant.
Effervescent aligner cleaning tablet
Over-the-counter effervescent cleaning tablet (containing surfactants and oxidizing agents such as sodium lauryl sulfate, potassium monopersulfate, and sodium perborate) used to clean removable thermoplastic orthodontic appliances. After toothbrushing the upper aligner, the participant dissolves one tablet in water and immerses the aligner for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. The same tablet product is used as the active cleaning agent in Arm D (in combination with an ultrasonic device).
Household ultrasonic cleaner with effervescent cleaning tablet
Small benchtop household ultrasonic cleaner operating at 42,000 Hz (42 kHz), used in combination with one effervescent aligner cleaning tablet dissolved in water in the cleaner's reservoir. After toothbrushing the upper aligner, the participant places it in the ultrasonic cleaner with the dissolved tablet and runs the unit for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. This intervention combines mechanical (acoustic micro-streaming) and chemical (oxidizing tablet) cleaning of the aligner surface.
Locations (1)
Riyadh Elm University
Riyadh, Saudi Arabia