Aerosol Generation in Dental Clinics

NCT05468099 | Completed

• 1 other identifier: Pro00103510
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Risk Reduction; Occupational Exposure; Dentist-Patient Transmission

Keywords

aerosol; bioaerosol; dentistry; orthodontics; saliva; nose

Outcome Measures

Primary Outcomes (3)

• Particle concentration measurements across the 4 different types of interventions

  During procedure

• Mass concentration measurements across the 4 different types of interventions

  During procedure

• 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 Outcomes (1)

• Bacterial contamination on the inside surface of the mask of operators and assistants

  During procedure

Study Arms (1)

Orthodontic debonding

EXPERIMENTAL

Other: Chlorhexidine mouthwash and Povidone-Iodine; Device: High volume evacuator; Device: High volume evactuator and saliva ejector; Device: Local Exhaust System

Interventions

Chlorhexidine mouthwash and Povidone-Iodine OTHER

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

Orthodontic debonding

High volume evacuator DEVICE

High volume evacuator held by assistant to capture dental spray

Orthodontic debonding

High volume evactuator and saliva ejector DEVICE

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

Orthodontic debonding

Local Exhaust System DEVICE

Local exhaust system hovers above patient head to capture dental spray

Orthodontic debonding

Eligibility Criteria

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

You may qualify if:

• Orthodontic debonding being performed
• Acceptance to participate in the study and provide required saliva and nasal samples

You may not qualify if:

• Refusal to participate
• Refusal to provide saliva/nasal swab samples
• Allergy to Chlorhexidine gluconate
• Allergy to Povidone-Iodine

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2L7, Canada

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Khaled Altabtbaei

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: March 29, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be published as soon as

Locations

CA (1)