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Dental Isolation Methods in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04430387
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Di Wu, DDS MS PhD, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Calculus, Dental Aerosol Disease Device: The saliva ejector Device: The high-volume evacuator Device: The DryShield Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor will be blind to group assignment of the patients
Primary Purpose: Supportive Care
Official Title: Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
Active Comparator: Group 1- The saliva ejector 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.

Active Comparator: Group 2- The high-volume evacuator 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.

Active Comparator: Group 3- The DryShield 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.




Primary Outcome Measures :
  1. To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry [ Time Frame: Through case completion, an average a year ]
    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.



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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430387


Contacts
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Contact: Di I Wu, DDS,MS,PhD 7135008220 di.wu@uth.tmc.edu
Contact: Brett Chiquet, DDS, PhD 7135008220 brett.t.chiquet@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Di Wu, DDS,MS,PhD    713-500-8220    Di.Wu@uth.tmc.edu   
Contact: Brett Chiquet, DDS,PhD    (713) 500-8220    brett.t.chiquet@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Di I Wu, DDS,MS,PhD UTHealth Science Center at Houston
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Di Wu, DDS MS PhD, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04430387    
Other Study ID Numbers: HSC-DB-20-0381
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Di Wu, DDS MS PhD, The University of Texas Health Science Center, Houston:
infection control
dental hygiene
spatter
aerosol
Additional relevant MeSH terms:
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Dental Plaque
Dental Calculus
Calculi
Pathological Conditions, Anatomical
Dental Deposits
Tooth Diseases
Stomatognathic Diseases