Dental Isolation Methods in Pediatric Patients

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04430387
• Other study ID #: HSC-DB-20-0381
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Aerosol Disease
• Calculi
• Calculus, Dental
• Dental Calculus
• Dental Plaque

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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