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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

2 months

Results posted on

2025-04-16

Participant Flow

Participant milestones

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.
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

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 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intraoral Suction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High & Low Suction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Extra-oral Suction & Low Suction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Extra-oral Suction and Intraoral Suction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zuhair Natto

King Abdulaziz University

Phone: 9666943899

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place