Nitrous Oxide Inhalation SedationNCT04734509
Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation
A study testing Silhouette breathing system in people with Nitrous Oxide Inhalation Sedation, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This is a randomised non-blinded controlled clinical trial, which involves the measurement of efficiency and acceptability of the Silhouette Mask system and compares it with the Porter Brown Mask system used for Inhalation Sedation in children having dental treatment at the Leeds Dental Institute. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nitrous Oxide Inhalation Sedation
- What is being tested?
- Silhouette breathing system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2019to 15 Aug 2019
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients attending the sedation unit for dental treatment under inhalation sedation.
- Children aged 7 to 15 years.
- American Society of Anaesthesiologists classification (ASA) Class I or II.
- Participants who can breathe through their nose/ no upper respiratory tract problems including large adenoids/tonsils.
- Able to follow and comply with instructions.
- First time using inhalation sedation.
Who cannot join
- Participants who are not able to communicate directly with the health care personnel carrying out the treatment.
- Uncooperative participants who refuse treatment on the dental chair.
- Participants who can't breathe through their nose (Mouth breathers).
- Participants who refuse to wear the mask.
- American Society of Anaesthesiologists classification ASA III and IV
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Dental Institute - LTHT
Leeds, West Yorkshire, LS2 9LU
About this study
This is a randomised non-blinded controlled clinical trial, which involves the measurement of efficiency and acceptability of the Silhouette Mask system and compares it with the Porter Brown Mask system used for Inhalation Sedation in children having dental treatment at the Leeds Dental Institute.
All eligible participants will be introduced to both masks (Porter Brown and Silhouette) in the assessment session prior to their first treatment session. Then participants will be randomly allocated to undergo treatment under nitrous oxide-oxygen inhalation sedation using either the Porter Brown or the Silhouette System. The efficiency and acceptability will be measured by a feedback questionnaire at the end of the treatment session and the scavenging efficiency will be measured by a diffusion pen which will measure the levels of nitrous oxide in the dentist's environment
Read the detailed description
This study is a "randomised non-blinded controlled clinical trial", where a total of fifty-four patients (n=54) will be recruited from the Sedation Unit (SU) at Leeds Dental Institute on the assessment appointment (1st visit). Participants will be randomly assigned to two different inhalation sedation breathing masks either the Porter Brown system or the Silhouette system on the day of the treatment session (2nd visit) using Block Randomisation. It is planned to recruit 4-6 patients every week until 54 participants are reached. On the assessment day (1st visit), Information Sheets and the procedures will be explained in details to parents and children in simplified language and questions will be answered. All participants will be introduced to both masks the Porter Brown system and Silhouette system. Then each participant will be given an appointment for the 2nd visit. On the treatment day (2nd visit), informed consent/assent will be explained and signed by those who meet the eligibility criteria. During the treatment session, a monitoring sheet will be used and data will be collected.
Prior to the start of the study a meeting will be convened with the trained sedation assistant and the lead researcher (HA) to explain the study and to introduce the breathing systems. The potential participants will be from the waiting list where patients are waiting for sedation appointments. The lead researcher who is part of the clinical care team will identify and contact those patients by sending them Information Sheets about the study through the post besides the first assessment appointment at least two weeks before the first visit.
On the assessment day (1st routine visit), Information Sheets and the procedures will be explained in details to parents and children in simple language and questions will be answered. Participants will be introduced to both masks then appointments for the 2nd visit will be given for commencement of dental treatment under inhalation sedation for patients who agreed to participate in this study. However, for the patients who did not meet the eligibility criteria or did not want to participate in the study, they will be given regular appointments for their treatment.
On the day of the treatment ( 2nd routine Visit) informed consent and assent forms will be explained and signed by those who met the eligibility criteria. Each participant will be treated under Inhalation Sedation using one of two routinely used breathing systems depending on the Block Randomization results. he participant will be asked to complete a feedback questionnaire related to the mask used which will add about 10 to 15 mins to their routine visit. Demographic Data such as Age, Gender and the treatment carried out, the Monitoring Data, Behaviour score will be collected from the patient's dental notes.
At the second visit, each participant will be treated under Inhalation Sedation using either the Silhouette or the Porter Brown mask system depending on the session Block Randomization results. Before starting the treatment session, each participant will be examined for eligibility, If the participant has a blocked nose for example, due to a common cold, he/ she will be rescheduled for another visit or otherwise the participant will proceed to have his/ her treatment session. During the treatment session, the lead researcher (HA) will setup and assemble the breathing system parts and choose the correct size of the mask for the patient. The lead researcher will also record airflow (including volume, patient breathing rate, and level of sedation) and collect participants' data.
In addition to that, the dental nurse sedation assistant will monitor the participant and record the information on the monitoring sheet. After the treatment session, the participant will be asked to complete a feedback questionnaire related to the mask used.
- Conditions
- Nitrous Oxide Inhalation Sedation
- Being tested
- Silhouette breathing system
- Keywords
- Nitrous oxide Inhalation Sedation, Silhouette Breathing System, Porter Brown Breathing system, Scavenging system, Comparison between two breathing systems, Silhouette Mask, Porter Brown Mask, Dental anxiety, Pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silhouette breathing systemDevice
Also called Silhouette Mask
The Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose.
| Study group | Role | What they receive |
|---|---|---|
| Porter Brown Breathing system | Experimental | The Porter Brown has a double mask system that is characterized by a mask-within-a-mask scavenging system. The system includes easy to remove inner masks which vent into the outer mask. This helps in cleaning and sterilization. The soft inner part of the mask system provides a comfortable fit and an excellent seal around the patient's nose.
This mask is routinely used in inhalation sedation for children's dental treatment.
This is a sterilisable system. Receives: Device: Silhouette breathing system |
| Silhouette Breathing system | Experimental | The Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose. Receives: Device: Silhouette breathing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scavenging efficiency of the two breathing systems
Its will be measured by calculating nitrous oxide levels in the ambient air using diffusion tubes. Diffusion tubes/pens work by molecular diffusion. The compound in the air has higher concentration than the tube, therefore compounds diffuse into the tube and collect on the absorbent at the end of the tube.
At the end of the sampling period, the pens will sealed by the lead researcher (HA) and sent to Gradko Environmental Laboratory for analysis.
Measured: through study completion, Up to an average of 1 year
Secondary outcomes (4)
Comfort of wearing the masks
Feedback about the comfort of wearing the masks (Porter Brown/ Silhouette) will be obtained from the study participants after the treatment session using a questionnaire, being developed and piloted prior to the start of the study Every child give their feedback at the end of their treatment session though a simple questionnaire
Measured: through study completion, an average of 1 year
Level of patient cooperation
The lead researcher (HA) who will provide treatment for all participants, will assess the level of patient cooperation and record it on a data-monitoring sheet at the end of the treatment session.
at the end of the treatment session, every child will be scored by the dentist (chief investigator)
Measured: through study completion, an average of 1 year
Child dental anxiety level before and after treatment session
The lead researcher will assess the dental anxiety level twice before and after the treatment session and then will record it in the data-monitoring sheet.
Dental anxiety level in children will be measured using the Facial Image Scale (FIS). This is measured twice for every child (participant), once prior the treatment started and the other one at the end of the treatment session
Measured: through study completion, an average of 1 year
Mask and circuit costs of the Porter Brown and the Silhouette systems
The Porter Brown is a reusable system that is being sterilised between use. the cost of each breathing system will be calculated at the end of the study, and compare between the two breathing systems However, the Silhouette is a disposable system. This study will calculate the costs and compare between the two systems.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start21 Feb 2019
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitrous Oxide Inhalation SedationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Alzaabi, University of Leeds
- Investigators
- Haya Alzaabi, Prof Doc Paed Dentistry, Principal investigator, University of Leeds, Leeds Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734509
- Sponsor's protocol ID
- 233026
- Status last verified
- Jan 2021
- First submitted
- 10 Dec 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Children participants were informed that in case the study was published, their information and data will be anonymised and will not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation
- ClinicalTrials.gov ID
- NCT04734509
- Acronym / sponsor ID
- 233026
- Conditions
- Nitrous Oxide Inhalation Sedation
- Keywords
- Nitrous oxide Inhalation Sedation, Silhouette Breathing System, Porter Brown Breathing system, Scavenging system, Comparison between two breathing systems, Silhouette Mask, Porter Brown Mask, Dental anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 2 Feb 2021 (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 is a randomised non-blinded controlled clinical trial, which involves the measurement of efficiency and acceptability of the Silhouette Mask system and compares it with the Porter Brown Mask system used for Inhalation Sedation in children having dental treatment at the Leeds Dental Institute.
All eligible participants will be introduced to both masks (Porter Brown and Silhouette) in the assessment session prior to their first treatment session. Then participants will be randomly allocated to undergo treatment under nitrous oxide-oxygen inhalation sedation using either the Porter Brown or the Silhouette System. The efficiency and acceptability will be measured by a feedback questionnaire at the end of the treatment session and the scavenging efficiency will be measured by a diffusion pen which will measure the levels of nitrous oxide in the dentist's environment
Detailed description
This study is a "randomised non-blinded controlled clinical trial", where a total of fifty-four patients (n=54) will be recruited from the Sedation Unit (SU) at Leeds Dental Institute on the assessment appointment (1st visit). Participants will be randomly assigned to two different inhalation sedation breathing masks either the Porter Brown system or the Silhouette system on the day of the treatment session (2nd visit) using Block Randomisation. It is planned to recruit 4-6 patients every week until 54 participants are reached. On the assessment day (1st visit), Information Sheets and the procedures will be explained in details to parents and children in simplified language and questions will be answered. All participants will be introduced to both masks the Porter Brown system and Silhouette system. Then each participant will be given an appointment for the 2nd visit. On the treatment day (2nd visit), informed consent/assent will be explained and signed by those who meet the eligibility criteria. During the treatment session, a monitoring sheet will be used and data will be collected.
Prior to the start of the study a meeting will be convened with the trained sedation assistant and the lead researcher (HA) to explain the study and to introduce the breathing systems. The potential participants will be from the waiting list where patients are waiting for sedation appointments. The lead researcher who is part of the clinical care team will identify and contact those patients by sending them Information Sheets about the study through the post besides the first assessment appointment at least two weeks before the first visit.
On the assessment day (1st routine visit), Information Sheets and the procedures will be explained in details to parents and children in simple language and questions will be answered. Participants will be introduced to both masks then appointments for the 2nd visit will be given for commencement of dental treatment under inhalation sedation for patients who agreed to participate in this study. However, for the patients who did not meet the eligibility criteria or did not want to participate in the study, they will be given regular appointments for their treatment.
On the day of the treatment ( 2nd routine Visit) informed consent and assent forms will be explained and signed by those who met the eligibility criteria. Each participant will be treated under Inhalation Sedation using one of two routinely used breathing systems depending on the Block Randomization results. he participant will be asked to complete a feedback questionnaire related to the mask used which will add about 10 to 15 mins to their routine visit. Demographic Data such as Age, Gender and the treatment carried out, the Monitoring Data, Behaviour score will be collected from the patient's dental notes.
At the second visit, each participant will be treated under Inhalation Sedation using either the Silhouette or the Porter Brown mask system depending on the session Block Randomization results. Before starting the treatment session, each participant will be examined for eligibility, If the participant has a blocked nose for example, due to a common cold, he/ she will be rescheduled for another visit or otherwise the participant will proceed to have his/ her treatment session. During the treatment session, the lead researcher (HA) will setup and assemble the breathing system parts and choose the correct size of the mask for the patient. The lead researcher will also record airflow (including volume, patient breathing rate, and level of sedation) and collect participants' data.
In addition to that, the dental nurse sedation assistant will monitor the participant and record the information on the monitoring sheet. After the treatment session, the participant will be asked to complete a feedback questionnaire related to the mask used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porter Brown Breathing system | Experimental | Device: Silhouette breathing systemThe Porter Brown has a double mask system that is characterized by a mask-within-a-mask scavenging system. The system includes easy to remove inner masks which vent into the outer mask. This helps in cleaning and sterilization. The soft inner part of the mask system provides a comfortable fit and an excellent seal around the patient's nose. This mask is routinely used in inhalation sedation for children's dental treatment. This is a sterilisable system. |
| Silhouette Breathing system | Experimental | Device: Silhouette breathing systemThe Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients attending the sedation unit for dental treatment under inhalation sedation.
- Children aged 7 to 15 years.
- American Society of Anaesthesiologists classification (ASA) Class I or II.
- Participants who can breathe through their nose/ no upper respiratory tract problems including large adenoids/tonsils.
- Able to follow and comply with instructions.
Key exclusion criteria (5 listed)
- Participants who are not able to communicate directly with the health care personnel carrying out the treatment.
- Uncooperative participants who refuse treatment on the dental chair.
- Participants who can't breathe through their nose (Mouth breathers).
- Participants who refuse to wear the mask.
- American Society of Anaesthesiologists classification ASA III and IV
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 |
|---|---|---|
| Silhouette breathing systemAlso: Silhouette MaskThe Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose. | Device | Porter Brown Breathing system, Silhouette Breathing system |
Primary outcome
The scavenging efficiency of the two breathing systems
Time frame: through study completion, Up to an average of 1 year
Its will be measured by calculating nitrous oxide levels in the ambient air using diffusion tubes. Diffusion tubes/pens work by molecular diffusion. The compound in the air has higher concentration than the tube, therefore compounds diffuse into the tube and collect on the absorbent at the end of the tube. At the end of the sampling period, the pens will sealed by the lead researcher (HA) and sent to Gradko Environmental Laboratory for analysis.
4 secondary outcomes
Comfort of wearing the masks
Time frame: through study completion, an average of 1 year
Level of patient cooperation
Time frame: through study completion, an average of 1 year
Child dental anxiety level before and after treatment session
Time frame: through study completion, an average of 1 year
Mask and circuit costs of the Porter Brown and the Silhouette systems
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Yes. Children participants were informed that in case the study was published, their information and data will be anonymised and will not be identified.
Related trials for Nitrous Oxide Inhalation Sedation
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
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.
Haya Alzaabi, Prof Doc Paed Dentistry principal investigator
University of Leeds, Leeds Dental Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silhouette breathing system in people with Nitrous Oxide Inhalation Sedation, run by University of Leeds at 1 site in United Kingdom.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The scavenging efficiency of the two breathing systems (time frame: through study completion, Up to an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.