Reducing Aerosol and Bioaerosol Using Different Oral Suctions

Infections Clinical Trial

Official title:

Reducing Aerosol And Bioaerosol Using Different Oral Suctions In Dental Clinic, Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848245
• Other study ID #: 351-12-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: July 2023

Study information

• Verified date: April 2023
• Source: King Abdulaziz University
• Contact: Zuhair Natto
• Phone: +966503620037
• Email: znatto[@]kau.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Oral Infection

Intervention

Device:
• Suction
Dental sections are used to absorb 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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