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Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners

NCT06503029 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

  • Malocclusion
  • Cytotoxicity

Interventions

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.

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.

DRUG

Listeren Mouthwash

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

DEVICE

Toothbrush and Water

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

Sponsors & Collaborators

  • Riyadh Elm University

    lead OTHER

Principal Investigators

  • Omar AlKadhi, BDS,MSc · Associated Professor, Riyadh Elm University.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-01-25
Completion
2025-03-05

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503029 on ClinicalTrials.gov