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.
Full Title of Study: “Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: November 2022
- 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.
- 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.
- 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.
Arms, Groups and Cohorts
- Active Comparator: Group 1- The saliva ejector
- Active Comparator: Group 2- The high-volume evacuator
- Active Comparator: Group 3- The DryShield
Clinical Trial Outcome Measures
- To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 4 Years
Maximum Age: 15 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- The University of Texas Health Science Center, Houston
- Provider of Information About this Clinical Study
- Principal Investigator: Di Wu, DDS MS PhD, Assistant Professor – The University of Texas Health Science Center, Houston
- Overall Official(s)
- Di I Wu, DDS,MS,PhD, Principal Investigator, UTHealth Science Center at Houston
- Overall Contact(s)
- Di I Wu, DDS,MS,PhD, 7135008220, email@example.com
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