NCT06503029

Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

Cytotoxicity, Leaching, and Structural Conformation of Invisalign Clear Aligners Subjected to Different Cleaning Methods: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Riyadh Elm University · Academic / Other
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.

Detailed description

Orthodontic Invisalign clear aligners patients will be randomly distributed into four groups using four cleaning methods. Participants will be instructed to clean their trays as instructed by the production company. Leaching, Cytotoxicity, and Structural Confirmation will be evaluated of the Invisalign clear aligners after being used.

Conditions

• Malocclusion
• Cytotoxicity

Interventions

Type	Name	Description
DEVICE	Invisalign Cleaning Crystals	Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
DEVICE	Fittey Dent Cleaning Tablet	Fittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient.
DRUG	Listeren Mouthwash	Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
DEVICE	Toothbrush and Water	Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-01-25
• Completion: 2025-03-05
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: Saudi Arabia