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Reducing Aerosol and Bioaerosol Using Different Oral Suctions

Primary Purpose

Infections, Oral Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suction
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    low suction

    intraoral suction

    high & low suction

    extra-oral suction & low suction

    extra-oral suction and intraoral suction

    Arm Description

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2023
    Last Updated
    April 27, 2023
    Sponsor
    King Abdulaziz University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848245
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Abdulaziz University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infections, Oral Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    low suction
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    intraoral suction
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    high & low suction
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    extra-oral suction & low suction
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    extra-oral suction and intraoral suction
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Suction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Particulate matter (PM)
    Description
    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.
    Time Frame
    2 months
    Title
    Microbial count
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zuhair Natto
    Phone
    +966503620037
    Email
    znatto@kau.edu.sa
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abrar Banan
    Phone
    +966549047007
    Email
    abannan0002@stu.kau.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zuhair Natto
    Organizational Affiliation
    King Abdulaziz University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to share any IPD with other researchers

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    Reducing Aerosol and Bioaerosol Using Different Oral Suctions

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