Dental Isolation Methods in Pediatric Patients

The University of Texas System (UT)

Status: Withdrawn

Conditions: Aerosol Disease; Dental Plaque; Calculus, Dental

Treatments: Device: The DryShield; Device: The saliva ejector; Device: The high-volume evacuator

Study type: Interventional

Funder types: Other

Identifiers

NCT04430387

HSC-DB-20-0381

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Group 1- The saliva ejector

Active Comparator group

Treatment:

Device: The saliva ejector

Group 2- The high-volume evacuator

Active Comparator group

Treatment:

Device: The high-volume evacuator

Group 3- The DryShield

Active Comparator group

Treatment:

Device: The DryShield