Clinical trial NCT05848245: Reducing Aerosol and Bioaerosol Using Different Oral Suctions
Official title: Reducing Aerosol And Bioaerosol Using Different Oral Suctions In Dental Clinic, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Oral Infection
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Particulate Matter (PM)
timeFrame: 2 months
measure: Microbial Count
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
affiliation: King Abdulaziz University
name: Zuhair Natto
role: PRINCIPAL_INVESTIGATOR
References: