Dental Isolation Methods in Pediatric Patients

Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Dental Plaque; Aerosol Disease; Calculus, Dental
• Intervention / Treatment: Device: The saliva ejector; Device: The high-volume evacuator; Device: The DryShield

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1- The saliva ejector	Device: The saliva ejector; A thin suction tube that draws water, saliva, blood, and debris from the mouth to provide patient comfort, preventing patient from constantly having to sit up and spit while maintain a clear operative field. It is connected through the low-volume suction hose in the dental chair. It can be held by the dental assistant, the dental provider or by the patient. In practice, it can be also contoured and hang by the cheek of the patient due to its light weight.
ACTIVE_COMPARATOR: Group 2- The high-volume evacuator	Device: The high-volume evacuator; The high-velocity air evacuation device. It is connected through the high-volume suction hose in the dental chair. It is operated by a dental assistant during the dental treatment, owing to the challenge posed by the rigid disposable attachment and bulky high-volume suction hose.
ACTIVE_COMPARATOR: Group 3- The DryShield	Device: The DryShield; The device is attached to the high-volume suction hose to provide continuous suction of intraoral fluid and debris, and also simultaneous isolation to both maxillary and mandibular quadrants on the same side. Other advantages of these devices include retracting the tongue and cheek, and prevention of aspiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry	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.	Through case completion, an average a year

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Di I Wu, DDS,MS,PhD, UTHealth Science Center at Houston

Publications and helpful links

General Publications

• Kumbargere Nagraj S, Eachempati P, Paisi M, Nasser M, Sivaramakrishnan G, Verbeek JH. Interventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013686. doi: 10.1002/14651858.CD013686.pub2.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: infection control; aerosol; dental hygiene; spatter
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathological Conditions, Anatomical; Tooth Diseases; Dental Deposits; Calculi; Dental Plaque; Dental Calculus
• Other Study ID Numbers: HSC-DB-20-0381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes