Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

Phase 4

Not yet recruiting

• Conditions: Cytotoxicity; Malocclusion
• Interventions: Device: Invisalign Cleaning Crystals; Drug: Listeren Mouthwash; Device: Fittey Dent Cleaning Tablet; Device: Toothbrush and Water

• Registration Number: NCT06503029
• Lead Sponsor: Riyadh Elm University

Brief 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study Start: 2024-07-15
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-01-25
• Study Completion: 2025-03-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Leaching	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
Cytotoxicity	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.
Structural Conformation	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.

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia