NCT06503029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 9, 2024

Last Update Submit

July 9, 2024

Conditions

MalocclusionCytotoxicity

Keywords

CytotoxicityLeachingClear alignerOrthodontics

Outcome Measures

Primary Outcomes (3)

  • Cytotoxicity

    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

    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

    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

Study Arms (4)

Invisalign Cleaning Crystals

EXPERIMENTAL

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

Fittey Dent Cleaning Tablet

EXPERIMENTAL

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

Listeren Mouthwash used as cleaning method

EXPERIMENTAL

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

Drug: Listeren Mouthwash

Toothbrush and water

ACTIVE COMPARATOR

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

Device: Toothbrush and Water

Interventions

Invisalign Cleaning CrystalsDEVICE

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

Invisalign Cleaning Crystals
Fittey Dent Cleaning TabletDEVICE

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

Fittey Dent Cleaning Tablet
Listeren MouthwashDRUG

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

Listeren Mouthwash used as cleaning method
Toothbrush and WaterDEVICE

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

Toothbrush and water

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Elm University

Riyadh, 12611, Saudi Arabia

Location

Related Publications (4)

  • Ahrari F, Tavakkol Afshari J, Poosti M, Brook A. Cytotoxicity of orthodontic bonding adhesive resins on human oral fibroblasts. Eur J Orthod. 2010 Dec;32(6):688-92. doi: 10.1093/ejo/cjq019. Epub 2010 Jun 21.

    PMID: 20570954BACKGROUND

  • Alhendi A, Khounganian R, Almudhi A. Cytotoxicity assessment of different clear aligner systems: An in vitro study. Angle Orthod. 2022 Sep 1;92(5):655-660. doi: 10.2319/121621-919.1. Epub 2022 Jun 7.

    PMID: 35666210BACKGROUND

  • Alhendi A, Khounganian R, Almudhi A, Ahamad SR. Leaching of Different Clear Aligner Systems: An In Vitro Study. Dent J (Basel). 2022 Feb 14;10(2):27. doi: 10.3390/dj10020027.

    PMID: 35200252BACKGROUND

  • Eliades T, Pratsinis H, Athanasiou AE, Eliades G, Kletsas D. Cytotoxicity and estrogenicity of Invisalign appliances. Am J Orthod Dentofacial Orthop. 2009 Jul;136(1):100-3. doi: 10.1016/j.ajodo.2009.03.006.

    PMID: 19577155BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Omar AlKadhi, BDS,MSc

    Associated Professor, Riyadh Elm University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara AlSenani, Resident

CONTACT

00966535599141yara.a.alsenanai2022@student.riyadh.edu.sa

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 16, 2024

Study Start

July 15, 2024

Primary Completion

January 25, 2025

Study Completion

March 5, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)