Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

Riyadh Elm University

Status and phase: Not yet enrolling; Phase 4

Conditions: Malocclusion; Cytotoxicity

Treatments: Device: Toothbrush and Water; Device: Invisalign Cleaning Crystals; Device: Fittey Dent Cleaning Tablet; Drug: Listeren Mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT06503029

FPGRP/2024/823/1114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who are on Invisalign Clear aligner treatment.
• Participants who are 21 years and older and committed to their treatment.
• Participants with caries-free dentition
• Participants with no smoking habits
• Participants are not pregnant females

Exclusion criteria

• Participants who are on Orthognathic treatment.
• Participants with Hypodontia.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 4 patient groups

Invisalign Cleaning Crystals

Experimental group

Description:

Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.

Treatment:

Device: Invisalign Cleaning Crystals

Fittey Dent Cleaning Tablet

Experimental group

Description:

Fittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient.

Treatment:

Device: Fittey Dent Cleaning Tablet

Listeren Mouthwash used as cleaning method

Experimental group

Description:

Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.

Treatment:

Drug: Listeren Mouthwash

Toothbrush and water

Active Comparator group

Description:

Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.

Treatment:

Device: Toothbrush and Water