Cleaning Methods for Clear Aligners

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

Conditions

• Orthodontic Appliances, Removable
• Dental Plaque
• Biofilms
• Disinfection
• Oral Hygiene in Orthodontic Patients

Interventions

DEVICE

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.

DRUG

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.

DRUG

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).

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.

Sponsors & Collaborators

• Riyadh Elm University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-17

Primary Completion

2021-03-09

Completion

2021-03-09

Countries

• Saudi Arabia

Study Locations