Reducing Aerosol and Bioaerosol Using Different Oral Suctions

NCT05848245 | Completed Results

• 1 other identifier: 351-12-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infections; Oral Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 months

Study Arms (5)

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.

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.

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.

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.

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.

Device: Extra-Oral Suction and Intraoral Suction

Interventions

low suction DEVICE

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.

low suction

intraoral suction DEVICE

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.

intraoral suction

high & low suction DEVICE

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.

high & low suction

extra-oral suction & low suction DEVICE

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 & low suction

Extra-Oral Suction and Intraoral Suction DEVICE

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.

extra-oral suction and intraoral suction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Number of teeth less than 20 teeth
• Presence of soft or hard tissue lesions
• Pregnant women
• Orthodontic patient
• Partial denture wearer

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 38419981 DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Dr. Zuhair Natto
• Organization: King Abdulaziz University

znatto@kau.edu.sa

9666943899

Study Officials

• Zuhair Natto

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)