InfectionsNCT05848245
Reducing Aerosol and Bioaerosol Using Different Oral Suctions
A study testing low suction, intraoral suction and high & low suction in people with Infections and Oral Infection, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Aerosol particles generated when using dental instrument such as ultrasonic and high air driven handpieces, this aerosol is mixture of blood, saliva, infectious agents, and dental materials. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infections, Oral Infection
- What is being tested?
- low suction, intraoral suction and high & low suction
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult healthy patient above 18 years of age
- Has scheduled an appointment at dental hygienist clinic for scaling procedure.
- Has at least one score 2 or 3 in one sextant according to community periodontal index of treatment needs (CPITN).
Who cannot join
- Number of teeth less than 20 teeth
- Presence of soft or hard tissue lesions
- Pregnant women
- Orthodontic patient
- Partial denture wearer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Aerosol And Bioaerosol Using Different Oral Suctions In Dental Clinic, Randomized Clinical Trial
Aerosol particles generated when using dental instrument such as ultrasonic and high air driven handpieces, this aerosol is mixture of blood, saliva, infectious agents, and dental materials. Inhaler dust that range between PM2.5 to PM10 could transferred to the human lung's terminal bronchioles and alveoli that cause a harm effect. The aim of this study to assess the effectiveness of different dental suction devices that could be contributed to decrease risk of particles count, Bacterial and fungal that arising from patient mouth to indoor air dental clinic. This is a randomized clinical trial will be conducted in three different places: educational hospital, public hospital, and private clinic. In each place 40 subject will be recruited. Measurement including particles count and microorganism will be taken before 15 minutes and during of scaling and prophylaxis procedure to measure particles count, oral bacteria, fungus, and microbial air. In this study will be compared between four intervention groups; Group A with high and low suction only, Group B using dry shield suction and low section, Group C using extra-oral suction with high and low suction, and Group D using dry shield suction and extra-oral suction and low section. Difference between each categorical groups and particle, oral bacterial, fungus, and microbial air concentration will be tested using two-way ANOVA test or one way ANOVA test. Statistical analysis will be carried using STATA version 13.
Read the detailed description
Aerosols described as any fluid and solid particles dropped in the air. Any particles less than 50 micrometer in diameter could be suspended into air for extended period before rest on environmental surfaces or enter respiratory tract. Bioaerosol are a complex mixture of airborne particles of biological origin such as bacteria, viruses, and fungus.
In dental clinic, dental team are exposed to infectious droplet through a direct contact with body fluid of patient, contact with environmental surfaces or instrument. Dental aerosol might be not easily to measure. However, many studies assess the amount of bacteria using bacteria growth media such as blood agar culture. In addition, particle number concentrations are considered as indication for health exposure risk to describe cleanroom. Particles in the range of 0.5-10 µm diameter can be inhaled and held on the human lung's terminal bronchioles and alveoli. Dental instruments and procedure generate varies air-borne contamination amount, the highest bacterial growth was produced by ultra-sonic scaler, followed by the air-driven high-speed handpiece, the air polisher and various other instruments such as the airwater syringe and prophylaxis angles. In addition, one of study in vitro was found the high amount of aerosol and spatter generated from ultrasonic scalar if used without cooling and presence of small amounts of liquid placed at the operative site to mimic blood and saliva.
Using personal protective barrier (PPE) would be prevented spatter droplets but particles which is less than 50 micrometer that consist of infectious agent has the potential to enter the respiratory tract through leaks in masks. The exact hazard effects of dental aerosol not possible to recognize currently however the probable spread of infection should be minimized and eliminated.
Infection control should be carried out to maximum level to provide safe environment in dental clinic. Controlling of aerosol and bioaerosol that generated through a different procedure is important to patient and dental staff in order to reduce transmission of infectious disease through direct contact with a surface prior to aerosol and bioaerosol settle down or through inhalation route.
- Conditions
- Infections, Oral Infection
- Being tested
- low suction, intraoral suction, high & low suction, extra-oral suction & low suction, Extra-Oral Suction and Intraoral Suction
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low suctionDevice
This group receives low-volume intraoral suction during procedures. Low suction typically refers to standard saliva ejectors, which provide minimal suction power and are commonly used in routine dental treatments.
intraoral suctionDevice
This group receives conventional intraoral suction, likely using high-volume evacuators (HVE), which are more effective than low suction. This arm serves as the comparison or standard-of-care group against which other interventions are evaluated.
high & low suctionDevice
Participants in this group receive both high-volume and low-volume intraoral suction simultaneously. The combined use aims to optimize fluid and aerosol control, with high suction capturing larger volumes and low suction assisting in continuous evacuation.
extra-oral suction & low suctionDevice
This group receives a combination of extra-oral suction (a device placed outside the mouth to capture aerosols at the source) and low-volume intraoral suction. This setup is designed to reduce airborne particles during procedures by controlling both intraoral and environmental aerosols.
Extra-Oral Suction and Intraoral SuctionDevice
This group is treated using both extra-oral suction and intraoral suction, likely high-volume. The dual approach targets aerosol containment both at the oral cavity level and in the surrounding air, representing a comprehensive strategy for infection control during aerosol-generating procedures.
| Study group | Role | What they receive |
|---|---|---|
| low suction | Experimental | It is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. Receives: Device: low suction |
| intraoral suction | Active comparator | Intraoral suction is attached to high volume excavation hose and provide continuous suction with a bite block, tongue, and oral pathway protection.It will be used as conventional way; intraoral suction will be hanged on patient mouth and moved it thoroughly as needed it, high suction will be moved with scaler, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. Receives: Device: intraoral suction |
| high & low suction | Experimental | Low section is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker.
High section is a large tube designed to suction large amount of air volume and droplet. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, high suction will be moved with scaler, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. Receives: Device: high & low suction |
| extra-oral suction & low suction | Experimental | EOS is used to remove aerosol and droplet that arising from patient mouth and filtering air. The device starts from air volume level 1 to level 10.
Low section is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. Receives: Device: extra-oral suction & low suction |
| extra-oral suction and intraoral suction | Experimental | EOS is used to remove aerosol and droplet that arising from patient mouth and filtering air. The device starts from air volume level 1 to level 10.
High section is a large tube designed to suction large amount of air volume and droplet. It will be used as conventional way; intraoral suction will be hanged on patient mouth and moved it thoroughly as needed it, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. Receives: Device: Extra-Oral Suction and Intraoral Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Particulate Matter (PM)
Amount of particulate matter will be measured using Digital dust monitor (model 3443, KANOMAX.USA INC., made in Japan). This device measure particle size that ranges from 0.1 to 10 µm using light scattering method (semiconductor laser radiation light source ) with flow rate of 1 L/min. air is collect through a filter which is built-in in order to eliminate coarse partials.
Measured: 2 months
Microbial Count
Amount of microbial contamination level. Active air sampler method will be used to collect microorganism onto solid media with flow rate 100 L/ min and lower d50 is 0.5µm. It contains 258 holes with diameter 0.7 mm. Positive hole correction should be used in order to adjust number of colonies forming units per volume of air (CFU m-3) according to the manual.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhair Saleh Natto, King Abdulaziz University
- Investigators
- Zuhair Natto, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848245
- Sponsor's protocol ID
- 351-12-21
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2023
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any IPD with other researchers
Publications
Bannan A, Kamal I, Al Makishah NH, Natto ZS. Reducing microbial airborne contamination and particulate matter using different oral suctions in dental clinic: A randomized controlled clinical trial. Saudi Dent J. 2024 Feb;36(2):374-380. doi: 10.1016/j.sdentj.2023.11.029. Epub 2023 Nov 28.
PubMed 38419981
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Aerosol And Bioaerosol Using Different Oral Suctions In Dental Clinic, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05848245
- Acronym / sponsor ID
- 351-12-21
- Conditions
- Infections, Oral Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aerosol particles generated when using dental instrument such as ultrasonic and high air driven handpieces, this aerosol is mixture of blood, saliva, infectious agents, and dental materials. Inhaler dust that range between PM2.5 to PM10 could transferred to the human lung's terminal bronchioles and alveoli that cause a harm effect. The aim of this study to assess the effectiveness of different dental suction devices that could be contributed to decrease risk of particles count, Bacterial and fungal that arising from patient mouth to indoor air dental clinic. This is a randomized clinical trial will be conducted in three different places: educational hospital, public hospital, and private clinic. In each place 40 subject will be recruited. Measurement including particles count and microorganism will be taken before 15 minutes and during of scaling and prophylaxis procedure to measure particles count, oral bacteria, fungus, and microbial air. In this study will be compared between four intervention groups; Group A with high and low suction only, Group B using dry shield suction and low section, Group C using extra-oral suction with high and low suction, and Group D using dry shield suction and extra-oral suction and low section. Difference between each categorical groups and particle, oral bacterial, fungus, and microbial air concentration will be tested using two-way ANOVA test or one way ANOVA test. Statistical analysis will be carried using STATA version 13.
Detailed description
Aerosols described as any fluid and solid particles dropped in the air. Any particles less than 50 micrometer in diameter could be suspended into air for extended period before rest on environmental surfaces or enter respiratory tract. Bioaerosol are a complex mixture of airborne particles of biological origin such as bacteria, viruses, and fungus.
In dental clinic, dental team are exposed to infectious droplet through a direct contact with body fluid of patient, contact with environmental surfaces or instrument. Dental aerosol might be not easily to measure. However, many studies assess the amount of bacteria using bacteria growth media such as blood agar culture. In addition, particle number concentrations are considered as indication for health exposure risk to describe cleanroom. Particles in the range of 0.5-10 µm diameter can be inhaled and held on the human lung's terminal bronchioles and alveoli. Dental instruments and procedure generate varies air-borne contamination amount, the highest bacterial growth was produced by ultra-sonic scaler, followed by the air-driven high-speed handpiece, the air polisher and various other instruments such as the airwater syringe and prophylaxis angles. In addition, one of study in vitro was found the high amount of aerosol and spatter generated from ultrasonic scalar if used without cooling and presence of small amounts of liquid placed at the operative site to mimic blood and saliva.
Using personal protective barrier (PPE) would be prevented spatter droplets but particles which is less than 50 micrometer that consist of infectious agent has the potential to enter the respiratory tract through leaks in masks. The exact hazard effects of dental aerosol not possible to recognize currently however the probable spread of infection should be minimized and eliminated.
Infection control should be carried out to maximum level to provide safe environment in dental clinic. Controlling of aerosol and bioaerosol that generated through a different procedure is important to patient and dental staff in order to reduce transmission of infectious disease through direct contact with a surface prior to aerosol and bioaerosol settle down or through inhalation route.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| low suction | Experimental | Device: low suctionIt is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. |
| intraoral suction | Active comparator | Device: intraoral suctionIntraoral suction is attached to high volume excavation hose and provide continuous suction with a bite block, tongue, and oral pathway protection.It will be used as conventional way; intraoral suction will be hanged on patient mouth and moved it thoroughly as needed it, high suction will be moved with scaler, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. |
| high & low suction | Experimental | Device: high & low suctionLow section is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker. High section is a large tube designed to suction large amount of air volume and droplet. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, high suction will be moved with scaler, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. |
| extra-oral suction & low suction | Experimental | Device: extra-oral suction & low suctionEOS is used to remove aerosol and droplet that arising from patient mouth and filtering air. The device starts from air volume level 1 to level 10. Low section is a small and narrow in diameter help to remove saliva , blood and debris and provide a clear vision to healthcare worker. It will be used as conventional way; low suction will be hanged on patient mouth and moved it thoroughly as needed it, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. |
| extra-oral suction and intraoral suction | Experimental | Device: Extra-Oral Suction and Intraoral SuctionEOS is used to remove aerosol and droplet that arising from patient mouth and filtering air. The device starts from air volume level 1 to level 10. High section is a large tube designed to suction large amount of air volume and droplet. It will be used as conventional way; intraoral suction will be hanged on patient mouth and moved it thoroughly as needed it, and extraoral suction where on right hand side of patient, power will be turned on to level 10, and suction cone will be facing patient mouth and it was away from its around 10 -15 cm based on the manufacturer instruction and to allow comfortable movement of the dental hygienist's hand. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult healthy patient above 18 years of age
- Has scheduled an appointment at dental hygienist clinic for scaling procedure.
- Has at least one score 2 or 3 in one sextant according to community periodontal index of treatment needs (CPITN).
Key exclusion criteria (5 listed)
- Number of teeth less than 20 teeth
- Presence of soft or hard tissue lesions
- Pregnant women
- Orthodontic patient
- Partial denture wearer
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 |
|---|---|---|
| low suctionThis group receives low-volume intraoral suction during procedures. Low suction typically refers to standard saliva ejectors, which provide minimal suction power and are commonly used in routine dental treatments. | Device | low suction |
| intraoral suctionThis group receives conventional intraoral suction, likely using high-volume evacuators (HVE), which are more effective than low suction. This arm serves as the comparison or standard-of-care group against which other interventions are evaluated. | Device | intraoral suction |
| high & low suctionParticipants in this group receive both high-volume and low-volume intraoral suction simultaneously. The combined use aims to optimize fluid and aerosol control, with high suction capturing larger volumes and low suction assisting in continuous evacuation. | Device | high & low suction |
| extra-oral suction & low suctionThis group receives a combination of extra-oral suction (a device placed outside the mouth to capture aerosols at the source) and low-volume intraoral suction. This setup is designed to reduce airborne particles during procedures by controlling both intraoral and environmental aerosols. | Device | extra-oral suction & low suction |
| Extra-Oral Suction and Intraoral SuctionThis group is treated using both extra-oral suction and intraoral suction, likely high-volume. The dual approach targets aerosol containment both at the oral cavity level and in the surrounding air, representing a comprehensive strategy for infection control during aerosol-generating procedures. | Device | extra-oral suction and intraoral suction |
Primary outcome
Particulate Matter (PM)
Time frame: 2 months
Amount of particulate matter will be measured using Digital dust monitor (model 3443, KANOMAX.USA INC., made in Japan). This device measure particle size that ranges from 0.1 to 10 µm using light scattering method (semiconductor laser radiation light source ) with flow rate of 1 L/min. air is collect through a filter which is built-in in order to eliminate coarse partials.
Microbial Count
Time frame: 2 months
Amount of microbial contamination level. Active air sampler method will be used to collect microorganism onto solid media with flow rate 100 L/ min and lower d50 is 0.5µm. It contains 258 holes with diameter 0.7 mm. Positive hole correction should be used in order to adjust number of colonies forming units per volume of air (CFU m-3) according to the manual.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38419981Bannan A, Kamal I, Al Makishah NH, Natto ZS. Reducing microbial airborne contamination and particulate matter using different oral suctions in dental clinic: A randomized controlled clinical trial. Saudi Dent J. 2024 Feb;36(2):374-380. doi: 10.1016/j.sdentj.2023.11.029. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No. There is no plan to share any IPD with other researchers
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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.
Zuhair Natto principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low suction, intraoral suction and high & low suction in people with Infections and Oral Infection, run by King Abdulaziz 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 3 inclusion and 5 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 16 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Particulate Matter (PM) (time frame: 2 months). The study lists 2 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 NCT05848245, which also lists 1 linked publication.
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 Apr 2025.