Risk ReductionNCT05468099
Aerosol Generation in Dental Clinics
A study testing Chlorhexidine mouthwash and Povidone-Iodine, High volume evacuator and High volume evactuator and saliva ejector in people with Risk Reduction and Occupational Exposure, run by University of Alberta at 1 site in Canada.
Trial summary
The study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction, Occupational Exposure, Dentist-Patient Transmission
- What is being tested?
- Chlorhexidine mouthwash and Povidone-Iodine, High volume evacuator and High volume evactuator and saliva ejector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 29 Mar 2022to 31 Jul 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Orthodontic debonding being performed
- Acceptance to participate in the study and provide required saliva and nasal samples
Who cannot join
- Refusal to participate
- Refusal to provide saliva/nasal swab samples
- Allergy to Chlorhexidine gluconate
- Allergy to Povidone-Iodine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigating Effect of Bioaerosols During Orthodontic Procedures: a Randomized Controlled Trial
The study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures.
Read the detailed description
We aim to examine 4 different methods to reduce dental aerosol spread during orthodontic procedures. These methods are: 1) high-volume evacuator, 2) high-volume evacuator and saliva ejector 3) Local Exhaust System 4) disinfection with povidone-iodine nasal swabs and chlorhexidine mouthwash.
- Being tested
- Chlorhexidine mouthwash and Povidone-Iodine, High volume evacuator, High volume evactuator and saliva ejector, Local Exhaust System
- Keywords
- aerosol, bioaerosol, dentistry, orthodontics, saliva, nose
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine mouthwash and Povidone-IodineOther
Chlorhexidine mouth rinse which participants use for 20 seconds before procedure. Moreover, Povidone-Iodine nasal swabs are used to disinfect nostrils
High volume evacuatorDevice
High volume evacuator held by assistant to capture dental spray
High volume evactuator and saliva ejectorDevice
High volume evacuator and saliva ejector held by assistant to capture dental spray
Local Exhaust SystemDevice
Local exhaust system hovers above patient head to capture dental spray
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic debonding | Experimental | Not described Receives: Other: Chlorhexidine mouthwash and Povidone-Iodine; Device: High volume evacuator; Device: High volume evactuator and saliva ejector; Device: Local Exhaust System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Particle concentration measurements across the 4 different types of interventions
Measured: During procedure
Mass concentration measurements across the 4 different types of interventions
Measured: During procedure
Bioaerosol measurement from the tracked sources
Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline
Measured: During procedure
Secondary outcomes (1)
Bacterial contamination on the inside surface of the mask of operators and assistants
Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start29 Mar 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled Altabtbaei, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468099
- Sponsor's protocol ID
- Pro00103510
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Bacteria rDNA sequences will be deposited in a public repository such as NCBI. Study protocol will be published along with the manuscript
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Effect of Bioaerosols During Orthodontic Procedures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05468099
- Acronym / sponsor ID
- Pro00103510
- Keywords
- aerosol, bioaerosol, dentistry, orthodontics, saliva, nose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Jul 2022 (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 study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures.
Detailed description
We aim to examine 4 different methods to reduce dental aerosol spread during orthodontic procedures. These methods are: 1) high-volume evacuator, 2) high-volume evacuator and saliva ejector 3) Local Exhaust System 4) disinfection with povidone-iodine nasal swabs and chlorhexidine mouthwash.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic debonding | Experimental | Other: Chlorhexidine mouthwash and Povidone-Iodine, Device: High volume evacuator, Device: High volume evactuator and saliva ejector, Device: Local Exhaust System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Orthodontic debonding being performed
- Acceptance to participate in the study and provide required saliva and nasal samples
Key exclusion criteria (4 listed)
- Refusal to participate
- Refusal to provide saliva/nasal swab samples
- Allergy to Chlorhexidine gluconate
- Allergy to Povidone-Iodine
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 |
|---|---|---|
| Chlorhexidine mouthwash and Povidone-IodineChlorhexidine mouth rinse which participants use for 20 seconds before procedure. Moreover, Povidone-Iodine nasal swabs are used to disinfect nostrils | Other | Orthodontic debonding |
| High volume evacuatorHigh volume evacuator held by assistant to capture dental spray | Device | Orthodontic debonding |
| High volume evactuator and saliva ejectorHigh volume evacuator and saliva ejector held by assistant to capture dental spray | Device | Orthodontic debonding |
| Local Exhaust SystemLocal exhaust system hovers above patient head to capture dental spray | Device | Orthodontic debonding |
Primary outcome
Particle concentration measurements across the 4 different types of interventions
Time frame: During procedure
Mass concentration measurements across the 4 different types of interventions
Time frame: During procedure
Bioaerosol measurement from the tracked sources
Time frame: During procedure
Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline
1 secondary outcome
Bacterial contamination on the inside surface of the mask of operators and assistants
Time frame: During procedure
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 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Bacteria rDNA sequences will be deposited in a public repository such as NCBI. Study protocol will be published along with the manuscript
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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.
Khaled Altabtbaei principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine mouthwash and Povidone-Iodine, High volume evacuator and High volume evactuator and saliva ejector in people with Risk Reduction and Occupational Exposure, run by University of Alberta at 1 site in Canada.
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 2 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 19 Sep 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 Canada. 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?
Particle concentration measurements across the 4 different types of interventions (time frame: During procedure). 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?
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 19 Sep 2024; AzTrials last refreshed its copy on 1 Nov 2026.