Back to resultsDental Isolation Methods in Pediatric Patients
Primary Purpose
Dental Plaque, Calculus, Dental, Aerosol Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The saliva ejector
The high-volume evacuator
The DryShield
Sponsored by
About this trial
This is an interventional supportive care trial for Dental Plaque focused on measuring infection control, dental hygiene, spatter, aerosol
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1- The saliva ejector
Group 2- The high-volume evacuator
Group 3- The DryShield
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04430387
First Posted
June 10, 2020
Last Updated
October 21, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04430387
Brief Title
Dental Isolation Methods in Pediatric Patients
Official Title
Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study initially aimed to measure droplets; however, as more was learned about COVID transmission, it became apparent that aerosol should be measured, but the method to measure aerosol was not possible for this study, so the study was withdrawn.
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Calculus, Dental, Aerosol Disease
Keywords
infection control, dental hygiene, spatter, aerosol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The assessor will be blind to group assignment of the patients
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1- The saliva ejector
Arm Type
Active Comparator
Arm Title
Group 2- The high-volume evacuator
Arm Type
Active Comparator
Arm Title
Group 3- The DryShield
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
The saliva ejector
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The high-volume evacuator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The DryShield
Intervention Description
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 Measure Information:
Title
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry
Description
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.
Time Frame
Through case completion, an average a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Di I Wu, DDS,MS,PhD
Organizational Affiliation
UTHealth Science Center at Houston
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not sharing
Citations:
PubMed Identifier
33047816
Citation
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.
Results Reference
derived
Learn more about this trial
Dental Isolation Methods in Pediatric Patients
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