Aerosol Generation in Dental Clinics

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05468099
Collaborator
(none)
40
1
1
10.8
3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Chlorhexidine mouthwash and Povidone-Iodine
  • Device: High volume evacuator
  • Device: High volume evactuator and saliva ejector
  • Device: Local Exhaust System
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Each participant and operator know the model which was assigned to them. The research assistant conducting the analysis is not able to identify the samples until analysis time.
Primary Purpose:
Prevention
Official Title:
Mitigating Effect of Bioaerosols During Orthodontic Procedures: A Randomized Controlled Trial
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orthodontic debonding

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

Device: High volume evactuator and saliva ejector
High volume evacuator and saliva ejector held by assistant to capture dental spray

Device: Local Exhaust System
Local exhaust system hovers above patient head to capture dental spray

Outcome Measures

Primary Outcome Measures

  1. Particle concentration measurements across the 4 different types of interventions [During procedure]

  2. Mass concentration measurements across the 4 different types of interventions [During procedure]

  3. Bioaerosol measurement from the tracked sources [During procedure]

    Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline

Secondary Outcome Measures

  1. Bacterial contamination on the inside surface of the mask of operators and assistants [During procedure]

    Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada T6G2L7

Sponsors and Collaborators

  • University of Alberta

Investigators

  • Principal Investigator: Khaled Altabtbaei, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Alberta
ClinicalTrials.gov Identifier:
NCT05468099
Other Study ID Numbers:
  • Pro00103510
First Posted:
Jul 21, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022