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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
|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.
- 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.
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
|Contact: Di I Wu, DDS,MS,PhDfirstname.lastname@example.org|
|Contact: Brett Chiquet, DDS, PhDemail@example.com|
|Principal Investigator:||Di I Wu, DDS,MS,PhD||UTHealth Science Center at Houston|