Reducing Aerosol and Bioaerosol Using Different Oral Suctions

NCT ID: NCT05848245

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-11-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

low suction

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

intraoral suction

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

high & low suction

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

extra-oral suction & low suction

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Extra-Oral Suction and Intraoral Suction

Intervention Type: 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.

Interventions

low suction

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.

Intervention Type: DEVICE

intraoral suction

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.

Intervention Type: DEVICE

high & low suction

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.

Intervention Type: DEVICE

extra-oral suction & low suction

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.

Intervention Type: DEVICE

Extra-Oral Suction and Intraoral Suction

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Zuhair Saleh Natto

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuhair Natto

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

King Abdulaziz University

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

References

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.

Reference Type: DERIVED

PMID: 38419981 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

351-12-21

Identifier Type: -

Identifier Source: org_study_id