Nitrous OxideNCT04305990
Demand-Driven Method for Gas Delivery in a Dental Setting
A study testing Demand-driven delivery method and Free-flow delivery method in people with Nitrous Oxide and Dentistry, run by University of Toronto at 1 site in Canada.
Trial summary
This study compares two methods of gas delivery in a dental setting: 1) demand-driven (DD) and 2) free-flow (FF). Nitrous oxide and oxygen sedation (NOS) is a common form of minimal sedation for adult and paediatric patients undergoing dental procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nitrous Oxide, Dentistry, Drug Delivery System
- What is being tested?
- Demand-driven delivery method and Free-flow delivery method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2020to Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be adults, 18 years of age or older.
- Participants must be ASA I (a normal, healthy patient) or ASA II (a patient with mild systemic disease).
Who cannot join
- Participants who are ASA III (a patient with a severe systemic disease that is not life-threatening) or higher.
- Participants who indicate they are claustrophobic.
- Participants with nasal obstruction of both nostrils.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Faculty of Dentistry
Toronto, Ontario, M5G 1G6
Ayala Y Rubin, BA DDS, 6479885202, ayala.rubin@utoronto.ca
Carilynne Yarascavitch, BSc DDS MSc, 416-864-8252, C.Yarascavitch@dentistry.utoronto.ca
About this study
Official title: Feasibility and Comfort of a Nasal Demand-Driven Method for Gas Delivery in a Dental Setting
This study compares two methods of gas delivery in a dental setting: 1) demand-driven (DD) and 2) free-flow (FF).
Nitrous oxide and oxygen sedation (NOS) is a common form of minimal sedation for adult and paediatric patients undergoing dental procedures. In order for NOS devices to be utilized during dental treatment, dentists must be able to provide gas flow to the patient, and subsequently scavenge used and unused gasses. Gas delivery is via a nasal mask, since the oral cavity must be accessible to the dentist throughout treatment.
Read more
Current devices for NOS in the dental setting utilize a free-flow gas method, where nitrous oxide and oxygen are released continuously from their tanks. The flow rate is set by the dentist according to the patient's minute ventilation needs, and unused and exhaled gasses are scavenged via the nasal mask. The demand-driven gas flow method, where inspiration triggers gas flow, has been used successfully in other medical settings, such as in obstetrics, medical emergencies, and for patients with chronic obstructive pulmonary disease. However, in these settings the mask used covers both the nose and mouth, and patients can trigger the demand-driven method through inspiration of the nose or mouth. The demand-driven gas flow method has a significant gas-sparing advantage over the free-flow method. With a demand-driven method, the patient dictates the flow rate and gas is only delivered when they are inspiring, compared to the free-flow method which provide gas flow throughout inspiration and expiration. However, the demand-driven method have not been studied in a dental setting where flow can only be triggered through the nose. It is therefore unknown whether it is feasible or comfortable for patients to trigger a demand-driven method nasally when their mouth is open during dental treatment.
This study will aim to assess the feasibility and comfort of a nasal demand-driven gas delivery method utilizing 100% oxygen in healthy, adult participants in a simulated dental setting. If the device is feasible and comfortable with 100% oxygen in a simulated dental setting, future research can be conducted to assess its use for NOS for dental treatment.
Read the detailed description
The study design is a within-subjects, single-blinded, randomized control trial. Participants will be randomzied to inspire 100% oxygen through their nose utilizing a demand-driven (DD) gas delivery method and a free-flow (FF) gas delivery method for 2 minutes each in a simulated dental setting.
The study will take place at the University of Toronto's Faculty of Dentistry Children's Clinic. Participants will be positioned supine in the dental chair. A child size, rubber bite block will be inserted with an attached capnography device to measure end-tidal carbon dioxide at the mouth. A double-mask nasal hood with disposable insert will be placed on the participant's nose. The participant will be instructed to breathe through their mouth for 1 minute. Baseline respiratory rate and presence/absence of end tidal carbon dioxide at the mouth will be obtained through the capnograph and recorded. The presence of carbon dioxide at baseline during mouth breathing will confirm that the capnograph is able to measure end-tidal carbon dioxide at the mouth.
The researcher will then open the envelope with the randomization plan for the participant and will indicate whether they will receive the FF or DD gas delivery method first. The gas delivery device will be attached to the nasal hood, and set to either DD or FF gas delivery method. Once the device is connected, the participant will be instructed to breathe through their nose for 2 minutes. During this time, respiratory rate, presence/absence of end tidal carbon dioxide at the mouth, and oxygen flow rate per minute will be observed and recorded. The absence of end-tidal carbon dioxide at the mouth during this testing phase will provide a verifiable measure that patients are breathing through their nose. After 2 minutes, the flow will be stopped and the bite block removed. The participant will be instructed to breathe through their mouth. The participant will then complete the VAS on comfort of breathing through their nose during the first gas flow delivery method. The bite block will then be reinserted, and the flow resumed using the second gas flow delivery method for 2 minutes. During this time, respiratory rate, presence/absence of end tidal carbon dioxide at the mouth, and oxygen flow rate per minute will be observed and recorded. After 2 minutes, the gas flow will once again be stopped and the bite block removed. The participant will be instructed to complete the VAS on comfort of breathing through their nose. The nasal hood will be removed. The participant will be debriefed to the order of gas flow received (DD or FF first) and the participant will then be dismissed.
- Conditions
- Nitrous Oxide, Dentistry, Drug Delivery System, Comfort, Feasibility, Drug Administration, Inhalation
- Being tested
- Demand-driven delivery method, Free-flow delivery method
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demand-driven delivery methodDevice
The gas delivery device is set to the demand-driven setting. Patients must inspire through their nose to trigger the flow of gas.
Free-flow delivery methodDevice
The gas delivery device is set to a free-flow setting. Gas flows through the system at a rate determined by the operator. Standard flow rate is 6 liters per minute. Patients do not need to inspire through their nose to trigger the flow of gas.
| Study group | Role | What they receive |
|---|---|---|
| Demand-driven delivery followed by free-flow delivery | Experimental | Participants will inspire 100% oxygen through their nose with the gas delivery device set to a demand-driven delivery setting through a nasal hood for 2 minutes followed by inspiration of 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes. Receives: Device: Demand-driven delivery method; Device: Free-flow delivery method |
| Free-flow delivery followed by demand-driven delivery | Experimental | Participants will inspire 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes followed by inspiration of 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes. Receives: Device: Demand-driven delivery method; Device: Free-flow delivery method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort of the demand-driven gas delivery mechanism
To assess patient comfort of breathing through their nose with the demand-driven gas delivery method vs the free-flow method. In order to assess comfort, the patient will report perceived comfort on a 100mm visual analog scale immediately after each device is turned on. We will test for non-inferiority in comfort of the demand-driven as compared to the free-flow delivery method.
Measured: Assessed immediately after breathing through each mechanism for 2 minutes
Feasibility of the demand-driven gas delivery mechanism
To assess whether it is feasible for participants to inspire 100% oxygen through a nasal hood when utilizing a demand-driven gas delivery mechanism when their mouth is open, in a simulated dental setting. In order to assess feasibility, we will monitor for the presence or absence end-tidal carbon dioxide at the mouth to confirm whether the patient is breathing through their nose or mouth. Absence of carbon dioxide at the mouth indicates the patient was able to trigger the mechanism and breathe through their nose.
Measured: Procedure (Assessed for the duration of time when the patient is breathing from either delivery system)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Nitrous OxideStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design is a within-subjects, single-blinded, randomized controlled trial. Each participant will receive both the free-flow (FF) and demand-driven (DD) gas delivery methods in a randomized sequence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- O-Two Medical Technologies
- Responsible party
- Principal investigator, Carilynne Yarascavitch, University of Toronto
- Investigators
- Carilynne Yarascavitch, BSc DDS MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305990
- Sponsor's protocol ID
- 00038876
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson S, Gosnell ES. Survey of American Academy of Pediatric Dentistry on Nitrous Oxide and Sedation: 20 Years Later. Pediatr Dent. 2016 Oct 15;38(5):385-392.
PubMed 28206894Malamed SF, Clark MS. Nitrous oxide-oxygen: a new look at a very old technique. J Calif Dent Assoc. 2003 May;31(5):397-403.
PubMed 12839232Becker DE, Rosenberg M. Nitrous oxide and the inhalation anesthetics. Anesth Prog. 2008 Winter;55(4):124-30; quiz 131-2. doi: 10.2344/0003-3006-55.4.124.
PubMed 19108597Clark MS, Brunick A. Handbook of Nitrous Oxide and Oxygen Sedation. 5th Edition ed: Elsevier Health Sciences; 2019.
Tiep BL, Nicotra MB, Carter R, Phillips R, Otsap B. Low-concentration oxygen therapy via a demand oxygen delivery system. Chest. 1985 May;87(5):636-8. doi: 10.1378/chest.87.5.636.
PubMed 3921316van der Kooy J, De Graaf JP, Kolder ZM, Witters KD, Fitzpatrick E, Duvekot JJ, Dons-Sinke IJ, Steegers EA, Bonsel GJ. A newly developed scavenging system for administration of nitrous oxide during labour: safe occupational use. Acta Anaesthesiol Scand. 2012 Aug;56(7):920-5. doi: 10.1111/j.1399-6576.2012.02668.x. Epub 2012 Mar 7.
PubMed 22404276Dallal GD. Randomization.com [updated July 15, 2008. Available from: ⟨http://www.randomization.com/⟩.
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
PubMed 16139163Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
PubMed 7584581Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
PubMed 19709436Humphris G, Crawford JR, Hill K, Gilbert A, Freeman R. UK population norms for the modified dental anxiety scale with percentile calculator: adult dental health survey 2009 results. BMC Oral Health. 2013 Jun 24;13:29. doi: 10.1186/1472-6831-13-29.
PubMed 23799962King K, Humphris G. Evidence to confirm the cut-off for screening dental phobia using the Modified Dental Anxiety Scale. Soc sci dent. 2010;1(1):21-8.
Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
PubMed 28722969
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Comfort of a Nasal Demand-Driven Method for Gas Delivery in a Dental Setting
- ClinicalTrials.gov ID
- NCT04305990
- Acronym / sponsor ID
- 00038876
- Conditions
- Nitrous Oxide, Dentistry, Drug Delivery System, Comfort, Feasibility, Drug Administration, Inhalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- O-Two Medical Technologies
- Study start
- Mar 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 12 Mar 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.
This study compares two methods of gas delivery in a dental setting: 1) demand-driven (DD) and 2) free-flow (FF).
Nitrous oxide and oxygen sedation (NOS) is a common form of minimal sedation for adult and paediatric patients undergoing dental procedures. In order for NOS devices to be utilized during dental treatment, dentists must be able to provide gas flow to the patient, and subsequently scavenge used and unused gasses. Gas delivery is via a nasal mask, since the oral cavity must be accessible to the dentist throughout treatment.
Current devices for NOS in the dental setting utilize a free-flow gas method, where nitrous oxide and oxygen are released continuously from their tanks. The flow rate is set by the dentist according to the patient's minute ventilation needs, and unused and exhaled gasses are scavenged via the nasal mask. The demand-driven gas flow method, where inspiration triggers gas flow, has been used successfully in other medical settings, such as in obstetrics, medical emergencies, and for patients with chronic obstructive pulmonary disease. However, in these settings the mask used covers both the nose and mouth, and patients can trigger the demand-driven method through inspiration of the nose or mouth. The demand-driven gas flow method has a significant gas-sparing advantage over the free-flow method. With a demand-driven method, the patient dictates the flow rate and gas is only delivered when they are inspiring, compared to the free-flow method which provide gas flow throughout inspiration and expiration. However, the demand-driven method have not been studied in a dental setting where flow can only be triggered through the nose. It is therefore unknown whether it is feasible or comfortable for patients to trigger a demand-driven method nasally when their mouth is open during dental treatment.
This study will aim to assess the feasibility and comfort of a nasal demand-driven gas delivery method utilizing 100% oxygen in healthy, adult participants in a simulated dental setting. If the device is feasible and comfortable with 100% oxygen in a simulated dental setting, future research can be conducted to assess its use for NOS for dental treatment.
Detailed description
The study design is a within-subjects, single-blinded, randomized control trial. Participants will be randomzied to inspire 100% oxygen through their nose utilizing a demand-driven (DD) gas delivery method and a free-flow (FF) gas delivery method for 2 minutes each in a simulated dental setting.
The study will take place at the University of Toronto's Faculty of Dentistry Children's Clinic. Participants will be positioned supine in the dental chair. A child size, rubber bite block will be inserted with an attached capnography device to measure end-tidal carbon dioxide at the mouth. A double-mask nasal hood with disposable insert will be placed on the participant's nose. The participant will be instructed to breathe through their mouth for 1 minute. Baseline respiratory rate and presence/absence of end tidal carbon dioxide at the mouth will be obtained through the capnograph and recorded. The presence of carbon dioxide at baseline during mouth breathing will confirm that the capnograph is able to measure end-tidal carbon dioxide at the mouth.
The researcher will then open the envelope with the randomization plan for the participant and will indicate whether they will receive the FF or DD gas delivery method first. The gas delivery device will be attached to the nasal hood, and set to either DD or FF gas delivery method. Once the device is connected, the participant will be instructed to breathe through their nose for 2 minutes. During this time, respiratory rate, presence/absence of end tidal carbon dioxide at the mouth, and oxygen flow rate per minute will be observed and recorded. The absence of end-tidal carbon dioxide at the mouth during this testing phase will provide a verifiable measure that patients are breathing through their nose. After 2 minutes, the flow will be stopped and the bite block removed. The participant will be instructed to breathe through their mouth. The participant will then complete the VAS on comfort of breathing through their nose during the first gas flow delivery method. The bite block will then be reinserted, and the flow resumed using the second gas flow delivery method for 2 minutes. During this time, respiratory rate, presence/absence of end tidal carbon dioxide at the mouth, and oxygen flow rate per minute will be observed and recorded. After 2 minutes, the gas flow will once again be stopped and the bite block removed. The participant will be instructed to complete the VAS on comfort of breathing through their nose. The nasal hood will be removed. The participant will be debriefed to the order of gas flow received (DD or FF first) and the participant will then be dismissed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design is a within-subjects, single-blinded, randomized controlled trial. Each participant will receive both the free-flow (FF) and demand-driven (DD) gas delivery methods in a randomized sequence.
| Arm | Type | Receives |
|---|---|---|
| Demand-driven delivery followed by free-flow delivery | Experimental | Device: Demand-driven delivery method, Device: Free-flow delivery methodParticipants will inspire 100% oxygen through their nose with the gas delivery device set to a demand-driven delivery setting through a nasal hood for 2 minutes followed by inspiration of 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes. |
| Free-flow delivery followed by demand-driven delivery | Experimental | Device: Demand-driven delivery method, Device: Free-flow delivery methodParticipants will inspire 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes followed by inspiration of 100% oxygen through their nose with the gas delivery device set to a free-flow delivery setting through a nasal hood for 2 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be adults, 18 years of age or older.
- Participants must be ASA I (a normal, healthy patient) or ASA II (a patient with mild systemic disease).
Key exclusion criteria (3 listed)
- Participants who are ASA III (a patient with a severe systemic disease that is not life-threatening) or higher.
- Participants who indicate they are claustrophobic.
- Participants with nasal obstruction of both nostrils.
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 |
|---|---|---|
| Demand-driven delivery methodThe gas delivery device is set to the demand-driven setting. Patients must inspire through their nose to trigger the flow of gas. | Device | Demand-driven delivery followed by free-flow delivery, Free-flow delivery followed by demand-driven delivery |
| Free-flow delivery methodThe gas delivery device is set to a free-flow setting. Gas flows through the system at a rate determined by the operator. Standard flow rate is 6 liters per minute. Patients do not need to inspire through their nose to trigger the flow of gas. | Device | Demand-driven delivery followed by free-flow delivery, Free-flow delivery followed by demand-driven delivery |
Primary outcome
Comfort of the demand-driven gas delivery mechanism
Time frame: Assessed immediately after breathing through each mechanism for 2 minutes
To assess patient comfort of breathing through their nose with the demand-driven gas delivery method vs the free-flow method. In order to assess comfort, the patient will report perceived comfort on a 100mm visual analog scale immediately after each device is turned on. We will test for non-inferiority in comfort of the demand-driven as compared to the free-flow delivery method.
Feasibility of the demand-driven gas delivery mechanism
Time frame: Procedure (Assessed for the duration of time when the patient is breathing from either delivery system)
To assess whether it is feasible for participants to inspire 100% oxygen through a nasal hood when utilizing a demand-driven gas delivery mechanism when their mouth is open, in a simulated dental setting. In order to assess feasibility, we will monitor for the presence or absence end-tidal carbon dioxide at the mouth to confirm whether the patient is breathing through their nose or mouth. Absence of carbon dioxide at the mouth indicates the patient was able to trigger the mechanism and breathe through their nose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Background: PubMed 28206894Wilson S, Gosnell ES. Survey of American Academy of Pediatric Dentistry on Nitrous Oxide and Sedation: 20 Years Later. Pediatr Dent. 2016 Oct 15;38(5):385-392.
- Background: PubMed 12839232Malamed SF, Clark MS. Nitrous oxide-oxygen: a new look at a very old technique. J Calif Dent Assoc. 2003 May;31(5):397-403.
- Background: PubMed 19108597Becker DE, Rosenberg M. Nitrous oxide and the inhalation anesthetics. Anesth Prog. 2008 Winter;55(4):124-30; quiz 131-2. doi: 10.2344/0003-3006-55.4.124.
- BackgroundClark MS, Brunick A. Handbook of Nitrous Oxide and Oxygen Sedation. 5th Edition ed: Elsevier Health Sciences; 2019.
- Background: PubMed 3921316Tiep BL, Nicotra MB, Carter R, Phillips R, Otsap B. Low-concentration oxygen therapy via a demand oxygen delivery system. Chest. 1985 May;87(5):636-8. doi: 10.1378/chest.87.5.636.
- Background: PubMed 22404276van der Kooy J, De Graaf JP, Kolder ZM, Witters KD, Fitzpatrick E, Duvekot JJ, Dons-Sinke IJ, Steegers EA, Bonsel GJ. A newly developed scavenging system for administration of nitrous oxide during labour: safe occupational use. Acta Anaesthesiol Scand. 2012 Aug;56(7):920-5. doi: 10.1111/j.1399-6576.2012.02668.x. Epub 2012 Mar 7.
- BackgroundDallal GD. Randomization.com [updated July 15, 2008. Available from: ⟨http://www.randomization.com/⟩.
- Background: PubMed 16139163Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
- Background: PubMed 7584581Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
- Background: PubMed 19709436Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
- Background: PubMed 23799962Humphris G, Crawford JR, Hill K, Gilbert A, Freeman R. UK population norms for the modified dental anxiety scale with percentile calculator: adult dental health survey 2009 results. BMC Oral Health. 2013 Jun 24;13:29. doi: 10.1186/1472-6831-13-29.
- BackgroundKing K, Humphris G. Evidence to confirm the cut-off for screening dental phobia using the Modified Dental Anxiety Scale. Soc sci dent. 2010;1(1):21-8.
- Individual participant dataSharing planned: No
Related trials for Nitrous Oxide
Not yet recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Not yet recruiting
Prospective Study To Assess The Outcomes Of Nitrous Oxide Cryoablation For Treatment Of Duodenal Adenomas In Patients With Hereditary Conditions Such As FAP, HNPCC
Prospective Study , Questionaires, Outcomes
Active, not recruiting
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
Barrett Esophagus, Intestinal Metaplasia
Not yet recruiting
Psychosocial Support for Nitrous Oxide Misuse
Brief Psychosocial Intervention
Recruiting
Concentrations of Nitrous Oxide in Blood, Exhaled Air and Urine After Various Types of Exposure.
Intoxication by Drug
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.
Carilynne Yarascavitch, BSc DDS MSc principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demand-driven delivery method and Free-flow delivery method in people with Nitrous Oxide and Dentistry, run by University of Toronto at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayala Y Rubin, BA DDS ((1)-647-988-5202, ayala.rubin@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort of the demand-driven gas delivery mechanism (time frame: Assessed immediately after breathing through each mechanism for 2 minutes). The study lists 2 primary outcomes in all. 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 NCT04305990, which also lists 13 linked publications.
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 12 Mar 2020.