Dental Isolation Methods in Pediatric Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Plaque, Calculus, Dental, Aerosol Disease

Intervention / Treatment
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* Device: The saliva ejector
* Device: The high-volume evacuator
* Device: The DryShield


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited subjects will be randomly assigned to one of the three study groups for isolation during their dental cleaning, which are: Group 1- The saliva ejector; Group 2- The high-volume evacuator (HVE); Group 3- The DryShield.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1- The saliva ejector<br> | Device: The saliva ejector<br>* 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.<br>|
| Active Comparator: Group 2- The high-volume evacuator<br> | Device: The high-volume evacuator<br>* 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.<br>|
| Active Comparator: Group 3- The DryShield<br> | Device: The DryShield<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerosol, infection control, dental hygiene, spatter