Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

July 9, 2024 updated by: Yara AlSenani, Riyadh Elm University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12611
        • Riyadh Elm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: Invisalign Cleaning Crystals
Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
Experimental: 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.
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.
Experimental: 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.
Drug: Listeren Mouthwash
Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Active Comparator: Toothbrush and water
Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.
Device: Toothbrush and Water
Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytotoxicity
Time Frame: 1-2month
Aligners from each of the four groups will be submerged in normal saline for a month at 37°C to conduct a cytotoxicity assessment. Following that, the solutions were diluted to three distinct concentrations (5%, 10%, and 20% volume/volume). After 48 hours of seeding in 96-well microplates, gingival fibroblasts were exposed to the solution, and the medium will be changed to an MTT solution (MTT: 3-[4,5-dime-thylthiazol-2-yl]-2,5-diphenyltetrazolium bromide). Then optical density will be measured to ascertain cell viability and subsequently assess cytotoxicity.
1-2month
Leaching
Time Frame: 1-2months

Each set of aligners from each of the four groups will be cut into 5x5 mm squares. To accelerate the degradation of the sample, each specimen will be submerged in a single glass vial with an alcoholic media. Each material will be soaked in five different solutions as follows: the first is absolute ethanol (100%), the second is 75% ethanol to 25% water, the third is 50% ethanol to water, the fourth is 25% ethanol to 75% water, and finally, 100% water solution served as the control.

A gas chromatography-mass spectrometry unit shall be used to analyze the leached substances in the immersion medium. An Agilent GC 7890A combined with a triple-axis detector 5975 C single quadrupole mass spectrometer will be used for GC-MS analysis
1-2months
Structural Conformation
Time Frame: 1-2months
Maxillary and mandibular clear aligners from all four included groups will be cut into 5 × 5 mm squares. Each specimen will be mounted in a plastic mold using an orthodontic plaster to facilitate the indentation process. The microhardness will be tested using a Vickers indenter (INNOVATEST, FALCON 450, Deutschland GmbH) by applying a 25 gf load for 15 s.
1-2months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Elm University

Investigators

  • Principal Investigator: Omar AlKadhi, BDS,MSc, Associated Professor, Riyadh Elm University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

January 25, 2025

Study Completion (Estimated)

March 5, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/2024/823/1114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malocclusion

Clinical Trials on Invisalign Cleaning Crystals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe