Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848245
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-08
First Post:
2023-04-14
Brief Title:
Reducing Aerosol and Bioaerosol Using Different Oral Suctions
Sponsor:
King Abdulaziz University
Organization:
King Abdulaziz University
Study Overview
Official Title:
Reducing Aerosol And Bioaerosol Using Different Oral Suctions In Dental Clinic Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PM25 to PM10 could transferred to the human lungs 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 05-10 µm diameter can be inhaled and held on the human lungs 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
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 05-10 µm diameter can be inhaled and held on the human lungs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None