Aerosol Generation in Dental Clinics

Risk Reduction Clinical Trial

Official title:

Mitigating Effect of Bioaerosols During Orthodontic Procedures: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468099
• Other study ID #: Pro00103510
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: Khaled Altabtbaei, PhD
• Phone: +1 (780) 492-0705
• Email: altabtba[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures.

Description:

We aim to examine 4 different methods to reduce dental aerosol spread during orthodontic procedures. These methods are: 1) high-volume evacuator, 2) high-volume evacuator and saliva ejector 3) Local Exhaust System 4) disinfection with povidone-iodine nasal swabs and chlorhexidine mouthwash.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Orthodontic debonding being performed

• Acceptance to participate in the study and provide required saliva and nasal samples

Exclusion Criteria:

• Refusal to participate

• Refusal to provide saliva/nasal swab samples

• Allergy to Chlorhexidine gluconate

• Allergy to Povidone-Iodine

Related Conditions & MeSH terms

• Occupational Exposure
• Risk Reduction

Intervention

Other:
• Chlorhexidine mouthwash and Povidone-Iodine
Chlorhexidine mouth rinse which participants use for 20 seconds before procedure. Moreover, Povidone-Iodine nasal swabs are used to disinfect nostrils

Device:
• High volume evacuator
High volume evacuator held by assistant to capture dental spray
• High volume evactuator and saliva ejector
High volume evacuator and saliva ejector held by assistant to capture dental spray
• Local Exhaust System
Local exhaust system hovers above patient head to capture dental spray

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Particle concentration measurements across the 4 different types of interventions		During procedure
Primary	Mass concentration measurements across the 4 different types of interventions		During procedure
Primary	Bioaerosol measurement from the tracked sources	Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline	During procedure
Secondary	Bacterial contamination on the inside surface of the mask of operators and assistants	Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline	During procedure