Orthodontic Appliances, RemovableNCT07610603
Cleaning Methods for Clear Aligners
A study testing Toothbrushing of clear aligner with water, Chlorhexidine gluconate 0.2% oral rinse and Effervescent aligner cleaning tablet in people with Orthodontic Appliances, Removable and Dental Plaque, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to learn which cleaning method best removes bacteria from clear plastic aligners. Clear aligners are removable orthodontic trays worn to straighten teeth. They sit against the teeth for 20 to 22 hours a day. Bacteria build up on their surfaces within days. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliances, Removable, Dental Plaque, Biofilms
- What is being tested?
- Toothbrushing of clear aligner with water, Chlorhexidine gluconate 0.2% oral rinse and Effervescent aligner cleaning tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Jan 2021to 9 Mar 2021
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 35 years
- Currently receiving thermoformed clear aligner orthodontic therapy in both the upper and lower arches
- Healthy periodontium (no active periodontal disease)
- Able and willing to wear assigned upper and lower aligners for 10 days as instructed
- Able and willing to perform the assigned cleaning method twice daily for 10 days
- Able to provide written informed consent
Who cannot join
- Use of any antibiotic within the previous month
- Current smoker
- Any relevant systemic disease that could affect oral microbial flora or healing
- Current use of any oral mouthwash or oral antiseptic product other than the trial product during the 10-day study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacterial Biofilm Evaluation of Four Methods for Cleaning Clear Aligners Using SEM: A Randomized Controlled Trial
The goal of this clinical trial is to learn which cleaning method best removes bacteria from clear plastic aligners. Clear aligners are removable orthodontic trays worn to straighten teeth. They sit against the teeth for 20 to 22 hours a day. Bacteria build up on their surfaces within days. No agreed-upon way to clean them exists.The main questions it aims to answer are:
Which of four common cleaning methods removes the most live bacteria from worn aligners? Which method leaves the least bacteria visible on the aligner surface under a microscope?
Read more
Researchers will compare four cleaning methods to see which works best:
Brushing with water (control) Soaking in chlorhexidine mouthwash Soaking in an effervescent cleaning tablet Using an ultrasonic cleaner together with a cleaning tablet
Participants will:
Wear one upper and one lower clear aligner for 10 days Clean the upper aligner twice a day for 5 minutes using their assigned method Return the aligner at the end of 10 days for laboratory testing
Read the detailed description
Rationale. Clear thermoplastic orthodontic aligners are worn for 20 to 22 hours per day in direct contact with the dentition. The fitting surface acquires a salivary pellicle and a polymicrobial biofilm within days of intraoral use, and the retained aligner-tooth microenvironment has been linked to plaque accumulation, gingival inflammation, and white spot lesions when oral hygiene is inadequate. There is currently no standardized protocol for aligner hygiene; patients are variously instructed to brush their aligners with water, soak them in mouthwash, immerse them in effervescent cleaning tablets, or use household ultrasonic devices. Existing evidence is largely in vitro, single-organism, or limited to thermoplastic retainers. This trial provides head-to-head clinical comparison of four commonly used regimens on bacterial load and biofilm coverage of worn aligners.Hypothesis. The null hypothesis is that the four cleaning methods do not differ in viable bacterial colony count, in bacterial coverage of the fitting surface scored under scanning electron microscopy, or in the prevalence of cultivable bacterial species.Randomization and blinding. A computer-generated simple random sequence (no blocking or stratification) was prepared by an independent statistician. Allocation was concealed in sequentially numbered opaque sealed envelopes opened by an independent coordinator. Outcome assessors, the microbiology laboratory staff, the SEM examiners, and the data analyst were blinded to group allocation. Participants were unblinded because the four cleaning methods differ in physical form.Sample size. Sample size was based on Alrabiah 2019. With an effect size of 0.63, alpha of 0.05, and power of 0.80, 11 participants per group were required; 15 per group were recruited to allow for withdrawals.Microbiological and SEM assays. Each worn upper aligner was sectioned at the right premolar region. The right half was immersed in 5 mL of LB broth, transported at 3 degrees Celsius to an accredited microbiology laboratory within 24 hours, and incubated at 37 degrees Celsius for 48 hours. CFU per milliliter was calculated from direct colony counts and the dilution factor. Bacterial species were identified using the VITEK-2 system with gram-positive and gram-negative cards. The left half was dried, mounted on SEM stubs with conductive carbon adhesive, sputter-coated with platinum, and examined at magnifications from 80x to 8,000x at 5 kV accelerating voltage. Two calibrated examiners independently scored bacterial coverage from grayscale histograms on a 1 to 4 ordinal scale.Statistical methods. Distributional checks were performed on the primary outcome. Because CFU departed from normality (Shapiro-Wilk P less than or equal to 0.003 in all four groups) and variances were heterogeneous (Levene P = 0.003), CFU and SEM coverage were compared between groups by the Kruskal-Wallis H test with Dunn-Bonferroni post hoc pairwise comparisons. Organism prevalence across the four groups was compared by the Fisher-Freeman-Halton exact test. The significance threshold was P less than 0.05. Analyses were performed in IBM SPSS Statistics version 22. Reporting conforms to the CONSORT 2025 statement.
- Conditions
- Orthodontic Appliances, Removable, Dental Plaque, Biofilms, Disinfection, Oral Hygiene in Orthodontic Patients
- Being tested
- Toothbrushing of clear aligner with water, Chlorhexidine gluconate 0.2% oral rinse, Effervescent aligner cleaning tablet, Household ultrasonic cleaner with effervescent cleaning tablet
- Keywords
- Clear aligners, Invisalign, Orthodontic aligners, Aligner cleaning, Biofilm, SEM, Chlorhexidine, Ultrasonic cleaning, Colony-forming units, Oral microbiome
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrushing of clear aligner with waterDevice
Mechanical cleaning of the upper clear aligner using a soft manual toothbrush and running tap water at room temperature. Cleaning is performed by the participant twice daily for 5 minutes per session, over a 10-day aligner cycle. No chemical agent, no ultrasonic device. This intervention serves as the comparator for the chemical and combined-cleaning regimens. The same brand of soft manual toothbrush is provided to all participants in the trial.
Chlorhexidine gluconate 0.2% oral rinseDrug
Aqueous oral antiseptic solution containing 0.2% chlorhexidine gluconate used as a soaking solution for the upper clear aligner (not as a mouth rinse for the participant). After toothbrushing the aligner, the participant immerses it in 10 mL of 0.2% chlorhexidine gluconate for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Chlorhexidine is used in this study as a device cleaning agent applied to the aligner surface, not as a therapeutic mouthwash administered to the participant.
Effervescent aligner cleaning tabletDrug
Over-the-counter effervescent cleaning tablet (containing surfactants and oxidizing agents such as sodium lauryl sulfate, potassium monopersulfate, and sodium perborate) used to clean removable thermoplastic orthodontic appliances. After toothbrushing the upper aligner, the participant dissolves one tablet in water and immerses the aligner for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. The same tablet product is used as the active cleaning agent in Arm D (in combination with an ultrasonic device).
Household ultrasonic cleaner with effervescent cleaning tabletDevice
Small benchtop household ultrasonic cleaner operating at 42,000 Hz (42 kHz), used in combination with one effervescent aligner cleaning tablet dissolved in water in the cleaner's reservoir. After toothbrushing the upper aligner, the participant places it in the ultrasonic cleaner with the dissolved tablet and runs the unit for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. This intervention combines mechanical (acoustic micro-streaming) and chemical (oxidizing tablet) cleaning of the aligner surface.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control (toothbrush with water) | Active comparator | Participants brush the fitting surface of the upper clear aligner with a soft manual toothbrush and running water at room temperature, twice daily for 5 minutes per cleaning session, for 10 days. No chemical cleaning agent and no ultrasonic device. Same toothbrush and toothpaste are used for the participant's own oral hygiene as for all other groups. Receives: Device: Toothbrushing of clear aligner with water |
| Group B: 0.2% chlorhexidine mouthwash immersion | Active comparator | Participants brush the upper clear aligner with a soft manual toothbrush and then immerse it for 5 minutes in 10 mL of 0.2% chlorhexidine gluconate mouthwash, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. Receives: Drug: Chlorhexidine gluconate 0.2% oral rinse |
| Group C: Effervescent cleaning tablet immersion | Active comparator | Participants brush the upper clear aligner with a soft manual toothbrush and then immerse it in water containing one dissolved effervescent aligner cleaning tablet for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. Receives: Drug: Effervescent aligner cleaning tablet |
| Group D: Ultrasonic cleaner with cleaning tablet | Active comparator | Participants brush the upper clear aligner with a soft manual toothbrush and then place it in a household ultrasonic cleaner (42,000 Hz) operated with one effervescent cleaning tablet dissolved in water, for 5 minutes per cleaning session, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. Receives: Device: Household ultrasonic cleaner with effervescent cleaning tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colony count (CFU/mL) on the fitting surface of the worn upper clear aligner
After 10 days of wear, each upper aligner is sectioned at the right premolar region (or the second premolar if the first bears an orthodontic attachment). The cut half is immersed in 5 mL of Luria-Bertani (LB) broth, transported at 3 degrees Celsius to an accredited microbiology laboratory within 24 hours, and incubated at 37 degrees Celsius for 48 hours. A parallel uninoculated LB tube is opened beside each sample to monitor environmental contamination. Bacterial colony-forming units per milliliter (CFU/mL) are calculated from direct colony counts and the dilution factor. Higher CFU/mL values indicate greater bacterial load on the aligner; lower values indicate more effective cleaning.
Measured: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
Secondary outcomes (2)
Bacterial coverage of the aligner fitting surface scored under scanning electron microscopy (1 to 4 ordinal scale)
After 10 days of wear, the contralateral half of each upper aligner (cut at the right premolar region as above) is dried, mounted on a scanning electron microscopy (SEM) stub with conductive carbon adhesive, sputter-coated with platinum, and examined at magnifications from 80x to 8,000x at 5 kV accelerating voltage. Two calibrated examiners independently score bacterial coverage of the fitting surface on a 4-level ordinal scale: 1 = 0 to 25 percent of the surface covered (best outcome); 2 = 25 to 50 percent covered; 3 = 50 to 75 percent covered; 4 = 75 to 100 percent covered (worst outcome). Examiners are blinded to group allocation. Lower scores indicate cleaner aligner surfaces and more effective cleaning.
Measured: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
Prevalence of cultivable bacterial species identified from the worn upper clear aligner
Bacterial species are identified from the broth cultures of the worn aligner using the VITEK-2 automated identification system (gram-positive and gram-negative cards). Prevalence is reported as the number and percentage of participants in each cleaning group whose aligner sample yields each identified species. This outcome characterizes the cultivable bacterial spectrum recovered from worn aligners under the four cleaning regimens. Species-level prevalence findings are exploratory and were not pre-specified for hypothesis testing.
Measured: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start17 Jan 2021
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliances, RemovableStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610603
- Sponsor's protocol ID
- FPGRP/2020/550/524
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alrabiah M, Alsahhaf A, Alofi RS, Al-Aali KA, Abduljabbar T, Vohra F. Efficacy of photodynamic therapy versus local nystatin in the treatment of denture stomatitis: A randomized clinical study. Photodiagnosis Photodyn Ther. 2019 Dec;28:98-101. doi: 10.1016/j.pdpdt.2019.08.028. Epub 2019 Aug 24.
PubMed 31454713Charavet C, Gourdain Z, Graveline L, Lupi L. Cleaning and Disinfection Protocols for Clear Orthodontic Aligners: A Systematic Review. Healthcare (Basel). 2022 Feb 10;10(2):340. doi: 10.3390/healthcare10020340.
PubMed 35206954
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Biofilm Evaluation of Four Methods for Cleaning Clear Aligners Using SEM: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07610603
- Acronym / sponsor ID
- FPGRP/2020/550/524
- Conditions
- Orthodontic Appliances, Removable, Dental Plaque, Biofilms, Disinfection, Oral Hygiene in Orthodontic Patients
- Keywords
- Clear aligners, Invisalign, Orthodontic aligners, Aligner cleaning, Biofilm, SEM, Chlorhexidine, Ultrasonic cleaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 28 May 2026 (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 goal of this clinical trial is to learn which cleaning method best removes bacteria from clear plastic aligners. Clear aligners are removable orthodontic trays worn to straighten teeth. They sit against the teeth for 20 to 22 hours a day. Bacteria build up on their surfaces within days. No agreed-upon way to clean them exists.The main questions it aims to answer are:
Which of four common cleaning methods removes the most live bacteria from worn aligners? Which method leaves the least bacteria visible on the aligner surface under a microscope?
Researchers will compare four cleaning methods to see which works best:
Brushing with water (control) Soaking in chlorhexidine mouthwash Soaking in an effervescent cleaning tablet Using an ultrasonic cleaner together with a cleaning tablet
Participants will:
Wear one upper and one lower clear aligner for 10 days Clean the upper aligner twice a day for 5 minutes using their assigned method Return the aligner at the end of 10 days for laboratory testing
Detailed description
Rationale. Clear thermoplastic orthodontic aligners are worn for 20 to 22 hours per day in direct contact with the dentition. The fitting surface acquires a salivary pellicle and a polymicrobial biofilm within days of intraoral use, and the retained aligner-tooth microenvironment has been linked to plaque accumulation, gingival inflammation, and white spot lesions when oral hygiene is inadequate. There is currently no standardized protocol for aligner hygiene; patients are variously instructed to brush their aligners with water, soak them in mouthwash, immerse them in effervescent cleaning tablets, or use household ultrasonic devices. Existing evidence is largely in vitro, single-organism, or limited to thermoplastic retainers. This trial provides head-to-head clinical comparison of four commonly used regimens on bacterial load and biofilm coverage of worn aligners.Hypothesis. The null hypothesis is that the four cleaning methods do not differ in viable bacterial colony count, in bacterial coverage of the fitting surface scored under scanning electron microscopy, or in the prevalence of cultivable bacterial species.Randomization and blinding. A computer-generated simple random sequence (no blocking or stratification) was prepared by an independent statistician. Allocation was concealed in sequentially numbered opaque sealed envelopes opened by an independent coordinator. Outcome assessors, the microbiology laboratory staff, the SEM examiners, and the data analyst were blinded to group allocation. Participants were unblinded because the four cleaning methods differ in physical form.Sample size. Sample size was based on Alrabiah 2019. With an effect size of 0.63, alpha of 0.05, and power of 0.80, 11 participants per group were required; 15 per group were recruited to allow for withdrawals.Microbiological and SEM assays. Each worn upper aligner was sectioned at the right premolar region. The right half was immersed in 5 mL of LB broth, transported at 3 degrees Celsius to an accredited microbiology laboratory within 24 hours, and incubated at 37 degrees Celsius for 48 hours. CFU per milliliter was calculated from direct colony counts and the dilution factor. Bacterial species were identified using the VITEK-2 system with gram-positive and gram-negative cards. The left half was dried, mounted on SEM stubs with conductive carbon adhesive, sputter-coated with platinum, and examined at magnifications from 80x to 8,000x at 5 kV accelerating voltage. Two calibrated examiners independently scored bacterial coverage from grayscale histograms on a 1 to 4 ordinal scale.Statistical methods. Distributional checks were performed on the primary outcome. Because CFU departed from normality (Shapiro-Wilk P less than or equal to 0.003 in all four groups) and variances were heterogeneous (Levene P = 0.003), CFU and SEM coverage were compared between groups by the Kruskal-Wallis H test with Dunn-Bonferroni post hoc pairwise comparisons. Organism prevalence across the four groups was compared by the Fisher-Freeman-Halton exact test. The significance threshold was P less than 0.05. Analyses were performed in IBM SPSS Statistics version 22. Reporting conforms to the CONSORT 2025 statement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Control (toothbrush with water) | Active comparator | Device: Toothbrushing of clear aligner with waterParticipants brush the fitting surface of the upper clear aligner with a soft manual toothbrush and running water at room temperature, twice daily for 5 minutes per cleaning session, for 10 days. No chemical cleaning agent and no ultrasonic device. Same toothbrush and toothpaste are used for the participant's own oral hygiene as for all other groups. |
| Group B: 0.2% chlorhexidine mouthwash immersion | Active comparator | Drug: Chlorhexidine gluconate 0.2% oral rinseParticipants brush the upper clear aligner with a soft manual toothbrush and then immerse it for 5 minutes in 10 mL of 0.2% chlorhexidine gluconate mouthwash, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. |
| Group C: Effervescent cleaning tablet immersion | Active comparator | Drug: Effervescent aligner cleaning tabletParticipants brush the upper clear aligner with a soft manual toothbrush and then immerse it in water containing one dissolved effervescent aligner cleaning tablet for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. |
| Group D: Ultrasonic cleaner with cleaning tablet | Active comparator | Device: Household ultrasonic cleaner with effervescent cleaning tabletParticipants brush the upper clear aligner with a soft manual toothbrush and then place it in a household ultrasonic cleaner (42,000 Hz) operated with one effervescent cleaning tablet dissolved in water, for 5 minutes per cleaning session, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Same toothbrush and toothpaste are used for the participant's own oral hygiene as in all other groups. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 35 years
- Currently receiving thermoformed clear aligner orthodontic therapy in both the upper and lower arches
- Healthy periodontium (no active periodontal disease)
- Able and willing to wear assigned upper and lower aligners for 10 days as instructed
- Able and willing to perform the assigned cleaning method twice daily for 10 days
Key exclusion criteria (4 listed)
- Use of any antibiotic within the previous month
- Current smoker
- Any relevant systemic disease that could affect oral microbial flora or healing
- Current use of any oral mouthwash or oral antiseptic product other than the trial product during the 10-day study period
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 |
|---|---|---|
| Toothbrushing of clear aligner with waterMechanical cleaning of the upper clear aligner using a soft manual toothbrush and running tap water at room temperature. Cleaning is performed by the participant twice daily for 5 minutes per session, over a 10-day aligner cycle. No chemical agent, no ultrasonic device. This intervention serves as the comparator for the chemical and combined-cleaning regimens. The same brand of soft manual toothbrush is provided to all participants in the trial. | Device | Group A: Control (toothbrush with water) |
| Chlorhexidine gluconate 0.2% oral rinseAqueous oral antiseptic solution containing 0.2% chlorhexidine gluconate used as a soaking solution for the upper clear aligner (not as a mouth rinse for the participant). After toothbrushing the aligner, the participant immerses it in 10 mL of 0.2% chlorhexidine gluconate for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. Chlorhexidine is used in this study as a device cleaning agent applied to the aligner surface, not as a therapeutic mouthwash administered to the participant. | Drug | Group B: 0.2% chlorhexidine mouthwash immersion |
| Effervescent aligner cleaning tabletOver-the-counter effervescent cleaning tablet (containing surfactants and oxidizing agents such as sodium lauryl sulfate, potassium monopersulfate, and sodium perborate) used to clean removable thermoplastic orthodontic appliances. After toothbrushing the upper aligner, the participant dissolves one tablet in water and immerses the aligner for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. The same tablet product is used as the active cleaning agent in Arm D (in combination with an ultrasonic device). | Drug | Group C: Effervescent cleaning tablet immersion |
| Household ultrasonic cleaner with effervescent cleaning tabletSmall benchtop household ultrasonic cleaner operating at 42,000 Hz (42 kHz), used in combination with one effervescent aligner cleaning tablet dissolved in water in the cleaner's reservoir. After toothbrushing the upper aligner, the participant places it in the ultrasonic cleaner with the dissolved tablet and runs the unit for 5 minutes, twice daily, for 10 days. The aligner is rinsed under running water before reinsertion in the mouth. This intervention combines mechanical (acoustic micro-streaming) and chemical (oxidizing tablet) cleaning of the aligner surface. | Device | Group D: Ultrasonic cleaner with cleaning tablet |
Primary outcome
Bacterial colony count (CFU/mL) on the fitting surface of the worn upper clear aligner
Time frame: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
After 10 days of wear, each upper aligner is sectioned at the right premolar region (or the second premolar if the first bears an orthodontic attachment). The cut half is immersed in 5 mL of Luria-Bertani (LB) broth, transported at 3 degrees Celsius to an accredited microbiology laboratory within 24 hours, and incubated at 37 degrees Celsius for 48 hours. A parallel uninoculated LB tube is opened beside each sample to monitor environmental contamination. Bacterial colony-forming units per milliliter (CFU/mL) are calculated from direct colony counts and the dilution factor. Higher CFU/mL values indicate greater bacterial load on the aligner; lower values indicate more effective cleaning.
2 secondary outcomes
Bacterial coverage of the aligner fitting surface scored under scanning electron microscopy (1 to 4 ordinal scale)
Time frame: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
Prevalence of cultivable bacterial species identified from the worn upper clear aligner
Time frame: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 31454713Alrabiah M, Alsahhaf A, Alofi RS, Al-Aali KA, Abduljabbar T, Vohra F. Efficacy of photodynamic therapy versus local nystatin in the treatment of denture stomatitis: A randomized clinical study. Photodiagnosis Photodyn Ther. 2019 Dec;28:98-101. doi: 10.1016/j.pdpdt.2019.08.028. Epub 2019 Aug 24.
- Background: PubMed 35206954Charavet C, Gourdain Z, Graveline L, Lupi L. Cleaning and Disinfection Protocols for Clear Orthodontic Aligners: A Systematic Review. Healthcare (Basel). 2022 Feb 10;10(2):340. doi: 10.3390/healthcare10020340.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing of clear aligner with water, Chlorhexidine gluconate 0.2% oral rinse and Effervescent aligner cleaning tablet in people with Orthodontic Appliances, Removable and Dental Plaque, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 29 May 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colony count (CFU/mL) on the fitting surface of the worn upper clear aligner (time frame: At the end of the 10-day aligner wear period (single endpoint, 10 days from randomization)). 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 NCT07610603, which also lists 2 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 29 May 2026.