MalocclusionPhase 4NCT06503029
Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners
A Phase 4 study testing Invisalign Cleaning Crystals, Fittey Dent Cleaning Tablet and Listeren Mouthwash in people with Malocclusion and Cytotoxicity, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Cytotoxicity
- What is being tested?
- Invisalign Cleaning Crystals, Fittey Dent Cleaning Tablet and Listeren Mouthwash
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jul 2024to 5 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participants who are on Orthognathic treatment.
- Participants with Hypodontia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytotoxicity, Leaching, and Structural Conformation of Invisalign Clear Aligners Subjected to Different Cleaning Methods: A Randomized Controlled 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.
Read the 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.
- Conditions
- Malocclusion, Cytotoxicity
- Being tested
- Invisalign Cleaning Crystals, Fittey Dent Cleaning Tablet, Listeren Mouthwash, Toothbrush and Water
- Keywords
- Cytotoxicity, Leaching, Clear aligner, Orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign Cleaning CrystalsDevice
Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
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.
Listeren MouthwashDrug
Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Toothbrush and WaterDevice
Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Toothbrush and Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1-2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion25 Jan 2025 (estimated)
- Study completion5 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara AlSenani, Riyadh Elm University
- Investigators
- Omar AlKadhi, BDS,MSc, Principal investigator, Associated Professor, Riyadh Elm University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503029
- Sponsor's protocol ID
- FPGRP/2024/823/1114
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20570954Alhendi 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.
PubMed 35666210Alhendi 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.
PubMed 35200252Eliades 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.
PubMed 19577155
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytotoxicity, Leaching, and Structural Conformation of Invisalign Clear Aligners Subjected to Different Cleaning Methods: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06503029
- Acronym / sponsor ID
- FPGRP/2024/823/1114
- Conditions
- Malocclusion, Cytotoxicity
- Keywords
- Cytotoxicity, Leaching, Clear aligner, Orthodontics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 5 Mar 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Invisalign Cleaning Crystals | Experimental | Device: Invisalign Cleaning CrystalsInvisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient. |
| Fittey Dent Cleaning Tablet | Experimental | Device: Fittey Dent Cleaning TabletFittey 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 | Drug: Listeren MouthwashListeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients. |
| Toothbrush and water | Active comparator | Device: Toothbrush and WaterToothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participants who are on Orthognathic treatment.
- Participants with Hypodontia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invisalign Cleaning CrystalsInvisalign 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 TabletFittey 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 MouthwashListeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients. | Drug | Listeren Mouthwash used as cleaning method |
| Toothbrush and WaterToothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer. | Device | Toothbrush and water |
Primary outcome
Cytotoxicity
Time frame: 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.
Leaching
Time frame: 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
Structural Conformation
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 20570954Ahrari 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.
- Background: PubMed 35666210Alhendi 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.
- Background: PubMed 35200252Alhendi 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.
- Background: PubMed 19577155Eliades 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar AlKadhi, BDS,MSc principal investigator
Associated Professor, Riyadh Elm University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Invisalign Cleaning Crystals, Fittey Dent Cleaning Tablet and Listeren Mouthwash in people with Malocclusion and Cytotoxicity, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara AlSenani, Resident (00966535599141, yara.a.alsenanai2022@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytotoxicity (time frame: 1-2month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503029, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.