Dental Isolation Methods in Pediatric Patients

Not Applicable

Withdrawn

• Conditions: Aerosol Disease; Calculus, Dental; Dental Plaque
• Interventions: Device: The DryShield; Device: The saliva ejector; Device: The high-volume evacuator

• Registration Number: NCT04430387
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-29
• Study Start: 2021-11-01
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ASA 1 patients
• Receiving dental prophylaxis or restorative procedure not requiring sedation or nitrous oxide
• Ability to cooperate in the dental chair
• Parents speak/read either English or Spanish and consent to study
• Child, when age appropriate, can assent to study

Exclusion Criteria

• Patients that do not meet the above criteria (including inability to cooperate or special health care need)
• Parents that do not speak/read either English or Spanish
• Children that do not assent (when age appropriate) to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3- The DryShield	The DryShield	-
Group 1- The saliva ejector	The saliva ejector	-
Group 2- The high-volume evacuator	The high-volume evacuator	-

Primary Outcome Measures

Name	Time	Method
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry	Through case completion, an average a year	The image of the spots of fluorescence from the spatter collected will be captured using a digital camera (Nikon D3100, Nikon, Tokyo, Japan) with an amber-colored lens cover. The image will be processed by a digital imaging software, ImageJ (National Institutes of Health, the Laboratory for Optical and Computational Instrumentation, University of Wisconsin) to get the number of the spots on each mask and film. The number of fluorescent spots is recorded to determine the amount of spatter produced.