Aerosol Generation in Dental Clinics

September 10, 2024 updated by: University of Alberta

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2L7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Particle concentration measurements across the 4 different types of interventions
Time Frame: During procedure
During procedure
Mass concentration measurements across the 4 different types of interventions
Time Frame: During procedure
During procedure
Bioaerosol measurement from the tracked sources
Time Frame: During procedure
Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial contamination on the inside surface of the mask of operators and assistants
Time Frame: During procedure
Sources include patient, operator and assistant saliva and nasal secretions, preprocedural ambient air, dental unit waterline
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Khaled Altabtbaei, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 10, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Bacteria rDNA sequences will be deposited in a public repository such as NCBI. Study protocol will be published along with the manuscript

IPD Sharing Time Frame

Will be published as soon as

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Occupational Exposure

Clinical Trials on Chlorhexidine mouthwash and Povidone-Iodine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe