A Randomised Controlled Clinical Trial on the Use of a Dental Aerosol Box to Prevent Microbial Transmission During Dental Procedure

NCT05034705 | Completed

• 1 other identifier: CSRG001-2020ST
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares the use of a dental aerosol box in preventing microbial transmission during dental procedure. Subjects requiring scaling treatment (BPE 2) will be recruited. Subjects will be allocated either into the control group (conventional suction method) or interventional group (dental aerosol box) Treatment will involve scaling of two quadrants, where data collection of the microbes will be taken. Secondary outcome will involve a self-administered questionnaire on patients acceptance over the scaling procedure either with conventional suction or using the dental aerosol box to contain the aerosol generated during the scaling procedure.

Conditions

Calculi

Outcome Measures

Primary Outcomes (1)

• Total bacterial count

  The index of microbial air contamination is based on the count of the microbial fallout on to Petri dishes left open to the air according to the 1/1/1 scheme (for 1h, 1m from the floor, at least 1m away from walls or any obstacle). This index corresponds to the values of CFU calculated from the culture plates of 9 cm diameter. The index of microbial air contamination will be assessed at rest (before the beginning of dental procedures) and in operational of procedures (during procedures) to determine changes in bacterial count due to dental treatment.

  30 mins

Secondary Outcomes (1)

• Patient acceptance of dental procedure

  1 treatment session, which is about 30 mins

Study Arms (2)

Active comparator: Conventional suction system

ACTIVE COMPARATOR

This is the conventional method of using the dental high volume suction to contain the aerosol generated during dental procedure. The saliva ejector will also be used.

Device: Conventional suction system

Experimental: Dental aerosol box with modified high volume evacuation system

EXPERIMENTAL

The dental aerosol box will be equipped with an exit for the high volume suction to be attached to contain the aerosol generated during dental procedure. The saliva ejector will also be used.

Device: Dental aerosol box with modified high volume evacuation system

Interventions

Conventional suction system DEVICE

This is the conventional method of using the dental high volume suction to contain the aerosol generated during dental procedure. The saliva ejector will also be used.

Active comparator: Conventional suction system

Dental aerosol box with modified high volume evacuation system DEVICE

The dental aerosol box will be equipped with an exit for the high volume suction to be attached to contain the aerosol generated during dental procedure. The saliva ejector will also be used.

Experimental: Dental aerosol box with modified high volume evacuation system

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BPE score of 2

You may not qualify if:

• BPE score of 1, 3 or 4
• Smoker
• Systemic disease

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

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Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Control - conventional suction system Interventional - dental aerosol box with modified high volume evacuation suction system

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: September 5, 2021
• Study Start: September 6, 2021
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)