Trial Outcomes & Findings for Reducing Aerosol and Bioaerosol Using Different Oral Suctions (NCT NCT05848245)
NCT ID: NCT05848245
Last Updated: 2025-04-16
Results Overview
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.
COMPLETED
NA
50 participants
2 months
2025-04-16
Participant Flow
Participant milestones
| Measure |
Low Suction
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.
|
Intraoral Suction
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.
|
High & Low Suction
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.
|
Extra-oral Suction & Low Suction
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.
|
Extra-oral Suction and Intraoral Suction
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.
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|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Suction
n=10 Participants
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.
|
Intraoral Suction
n=10 Participants
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.
|
High & Low Suction
n=10 Participants
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.
|
Extra-oral Suction & Low Suction
n=10 Participants
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.
|
Extra-oral Suction and Intraoral Suction
n=10 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.4 Years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
32.8 Years
STANDARD_DEVIATION 5.4 • n=10 Participants
|
31 Years
STANDARD_DEVIATION 10.8 • n=10 Participants
|
36.9 Years
STANDARD_DEVIATION 7.6 • n=10 Participants
|
31.4 Years
STANDARD_DEVIATION 9 • n=10 Participants
|
34.4 Years
STANDARD_DEVIATION 8.1 • n=50 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
21 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
29 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
microbial airborne contamination level
|
28.4 CFU m -3
STANDARD_DEVIATION 14.1 • n=10 Participants
|
28.7 CFU m -3
STANDARD_DEVIATION 15.0 • n=10 Participants
|
56.3 CFU m -3
STANDARD_DEVIATION 39.2 • n=10 Participants
|
56.8 CFU m -3
STANDARD_DEVIATION 35.6 • n=10 Participants
|
31.2 CFU m -3
STANDARD_DEVIATION 10.8 • n=10 Participants
|
42.6 CFU m -3
STANDARD_DEVIATION 28.3 • n=50 Participants
|
|
Particulate matter
|
121.3 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 12.6 • n=10 Participants
|
135.1 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 33.8 • n=10 Participants
|
147.6 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 30.2 • n=10 Participants
|
128.4 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 22.3 • n=10 Participants
|
136.9 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 29.9 • n=10 Participants
|
133.9 micrograms per cubic meter (µg/m³)
STANDARD_DEVIATION 27.2 • n=50 Participants
|
PRIMARY outcome
Timeframe: 2 monthsAmount 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.
Outcome measures
| Measure |
Low Suction
n=10 Participants
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.
|
Intraoral Suction
n=10 Participants
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.
|
High & Low Suction
n=10 Participants
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.
|
Extra-oral Suction & Low Suction
n=10 Participants
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.
|
Extra-oral Suction and Intraoral Suction
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Particulate Matter (PM)
|
121.3 micrograms per cubic meter (µg/m³)
Standard Deviation 12.6
|
135.1 micrograms per cubic meter (µg/m³)
Standard Deviation 33.8
|
147.6 micrograms per cubic meter (µg/m³)
Standard Deviation 30.2
|
128.4 micrograms per cubic meter (µg/m³)
Standard Deviation 22.3
|
136.9 micrograms per cubic meter (µg/m³)
Standard Deviation 29.9
|
PRIMARY outcome
Timeframe: 2 monthsAmount 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.
Outcome measures
| Measure |
Low Suction
n=10 Participants
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.
|
Intraoral Suction
n=10 Participants
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.
|
High & Low Suction
n=10 Participants
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.
|
Extra-oral Suction & Low Suction
n=10 Participants
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.
|
Extra-oral Suction and Intraoral Suction
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Microbial Count
|
1117 CFU/m³
Standard Deviation 624.1
|
325.1 CFU/m³
Standard Deviation 336.2
|
100.2 CFU/m³
Standard Deviation 88.3
|
74.2 CFU/m³
Standard Deviation 28.3
|
45.6 CFU/m³
Standard Deviation 14.7
|
Adverse Events
Low Suction
Intraoral Suction
High & Low Suction
Extra-oral Suction & Low Suction
Extra-oral Suction and Intraoral Suction
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place