NCT04430387

Dental Isolation Methods in Pediatric Patients

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Plaque
• Calculus, Dental
• Aerosol Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-06-12
• Last updated: 2021-10-29

Regulatory

• FDA-regulated device study