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Dental Isolation Methods in Pediatric Patients

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04430387
Enrollment
0
Registered
2020-06-12
Start date
2021-11-01
Completion date
2022-11-30
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerosol Disease, Calculus, Dental, Dental Plaque

Keywords

infection control, dental hygiene, spatter, aerosol

Brief 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.

Interventions

DEVICEThe 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.

DEVICEThe 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.

DEVICEThe 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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessor will be blind to group assignment of the patients

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistryThrough case completion, an average a yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026