Dental PlaqueNCT04430387
Dental Isolation Methods in Pediatric Patients
A study testing The saliva ejector, The high-volume evacuator and The DryShield in people with Dental Plaque and Calculus, Dental, run by The University of Texas Health Science Center, Houston.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Calculus, Dental, Aerosol Disease
- What is being tested?
- The saliva ejector, The high-volume evacuator and The DryShield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients
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
- Being tested
- The saliva ejector, The high-volume evacuator, The DryShield
- Keywords
- infection control, dental hygiene, spatter, aerosol
- Medical subject headings
- Dental Plaque, Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The saliva ejectorDevice
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.
The high-volume evacuatorDevice
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.
The DryShieldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- The saliva ejector | Active comparator | Not described Receives: Device: The saliva ejector |
| Group 2- The high-volume evacuator | Active comparator | Not described Receives: Device: The high-volume evacuator |
| Group 3- The DryShield | Active comparator | Not described Receives: Device: The DryShield |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through case completion, an average a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Nov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Wu, DDS MS PhD, The University of Texas Health Science Center, Houston
- Investigators
- Di I Wu, DDS,MS,PhD, Principal investigator, UTHealth Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430387
- Sponsor's protocol ID
- HSC-DB-20-0381
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not sharing
Publications
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.
PubMed 33047816
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients
- ClinicalTrials.gov ID
- NCT04430387
- Acronym / sponsor ID
- HSC-DB-20-0381
- Conditions
- Dental Plaque, Calculus, Dental, Aerosol Disease
- Keywords
- infection control, dental hygiene, spatter, aerosol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The saliva ejectorA 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. | Device | Group 1- The saliva ejector |
| The high-volume evacuatorThe 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. | Device | Group 2- The high-volume evacuator |
| The DryShieldThe 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. | Device | Group 3- The DryShield |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Derived from this study: PubMed 33047816Kumbargere 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.
- Individual participant dataSharing planned: No. Not sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Di I Wu, DDS,MS,PhD principal investigator
UTHealth Science Center at Houston
Questions about this trial
What is this clinical trial studying?
A study testing The saliva ejector, The high-volume evacuator and The DryShield in people with Dental Plaque and Calculus, Dental, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.