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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invisalign Cleaning Crystals | Device | Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yara AlSenani, Resident | Contact | 00966535599141 | yara.a.alsenanai2022@student.riyadh.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Omar AlKadhi, BDS,MSc | Associated Professor, Riyadh Elm University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riyadh Elm University | Riyadh | 12611 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20570954 | Background | 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. | |
| 35666210 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.
| Fittey Dent Cleaning Tablet | Device | Fittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient. |
|
| Listeren Mouthwash | Drug | Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients. |
|
| Toothbrush and Water | Device | Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer. |
|
| 35200252 | Background | 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. |
| 19577155 | Background | 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. |