Dental Isolation Methods in Pediatric Patients

NCT04430387 | Withdrawn FDA Device

• 1 other identifier: HSC-DB-20-0381
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Plaque; Calculus, Dental; Aerosol Disease

Keywords

infection control; dental hygiene; spatter; aerosol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1- The saliva ejector

ACTIVE COMPARATOR

Device: The saliva ejector

Group 2- The high-volume evacuator

ACTIVE COMPARATOR

Device: The high-volume evacuator

Group 3- The DryShield

ACTIVE COMPARATOR

Device: The DryShield

Interventions

The saliva ejector DEVICE

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.

Group 1- The saliva ejector

The high-volume evacuator DEVICE

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.

Group 2- The high-volume evacuator

The DryShield DEVICE

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.

Group 3- The DryShield

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Related Publications (1)

• Kumbargere Nagraj S, Eachempati P, Paisi M, Nasser M, Sivaramakrishnan G, Verbeek JH. Interventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013686. doi: 10.1002/14651858.CD013686.pub2.

  PMID: 33047816 DERIVED

MeSH Terms

Conditions

Dental Plaque; Dental Calculus

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Di I Wu, DDS,MS,PhD

  UTHealth Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to group assignment of the patients
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share