Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-40
SponsorRiyadh Elm University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participants who are on Orthognathic treatment.
Participants with Hypodontia.
Trial design
Design model
Parallel
Treatments tested in this trial
Invisalign Cleaning Crystals
DeviceInvisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
Fittey Dent Cleaning Tablet
DeviceFittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient.
Listeren Mouthwash
DrugListeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Toothbrush and Water
DeviceToothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.
Treatment groups
84 Participants
are divided into 4 treatment groupsGroup A: Invisalign Cleaning CrystalsExperimental treatment 1 intervention
Group B: Fittey Dent Cleaning TabletExperimental treatment 1 intervention
Group C: Listeren Mouthwash used as cleaning methodExperimental treatment 1 intervention
Group D: Toothbrush and waterActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1-2month2
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
Time frame
1-2months3
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.
Time frame
1-2monthsSponsors and contacts
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Source ClinicalTrials.gov
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