Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-03-05

Brief Summary

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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.

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Detailed Description

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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

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Malocclusion Cytotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

To maintain anonymity, unique identification numbers will be generated for each patient, and the data obtained will be carefully coded. This will ensure that patient data is kept separate from other collected data and stored in a secure and protected location.

Study Groups

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Invisalign Cleaning Crystals

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

Group Type EXPERIMENTAL

Invisalign Cleaning Crystals

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Fittey Dent Cleaning Tablet

Intervention Type DEVICE

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

Listeren Mouthwash used as cleaning method

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

Group Type EXPERIMENTAL

Listeren Mouthwash

Intervention Type DRUG

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

Toothbrush and water

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

Group Type ACTIVE_COMPARATOR

Toothbrush and Water

Intervention Type DEVICE

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

Interventions

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Invisalign Cleaning Crystals

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

Intervention Type 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.

Intervention Type DEVICE

Listeren Mouthwash

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

Intervention Type DRUG

Toothbrush and Water

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

Intervention Type DEVICE

Eligibility Criteria

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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