Dental AnxietyNCT06056492
Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.
A study testing Experience of nitrous oxide sedation at assessment in people with Dental Anxiety, run by Dr Richard Balmer at 1 site in United Kingdom.
Trial summary
The purpose of this study is to find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Experience of nitrous oxide sedation at assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 1 Jun 2021
- 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 5 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 5 to 15 years.
- ASA Class I or II.
- First time having inhalation sedation.
Who cannot join
- Participants who refuse to wear the mask.
- Language barriers where no interpreter was available
- Parents/Carer who refused to sign consent or children who did not assent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LE2 9LU
About this study
The purpose of this study is to find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session.
Read the detailed description
Title: Effectiveness of children experiencing nitrous oxide/oxygen inhalation sedation at an assessment visit before having treatment.
Background: Dental anxiety is a common problem, affecting people of all ages, but predominantly children and adolescents. Inhalation sedation (IHS) using nitrous oxide/oxygen (N2O/O2) mixture is a pharmacological behaviour management technique that is widely used to manage dental anxiety in children. It is suggested that the use of an acclimatisation would increase the acceptability and the efficacy of N2O/O2 success. Even though the introductory appointment has been widely proposed, there have not been any studies conducted to measure the effectiveness of this appointment in improving the success of N2O/O2 sedation in children.
Aims: This study aimed to investigate the effect of experience of nitrous oxide/oxygen sedation at assessment prior to dental inhalation sedation on children's anxiety.
Methods: The study was a parallel randomised non blinded control clinical trial. Children aged five to fifteen years who were seen at the Leeds Dental Institute for dental treatment under inhalation sedation were recruited on the assessment appointment (1st visit). Both two groups received an assessment appointment, however participants of the study group tried on the mask and the nitrous oxide/oxygen sedation while the ones of the control group tried on the mask without the nitrous oxide/oxygen sedation. Following the assessment appointment, both groups received a second appointment for treatment. Dental anxiety was measured through two different methods. Primarily through the MCDASf questionnaire, which was completed once at the beginning of the assessment visit and twice at the beginning and end of the treatment visit. Secondarily anxiety was measured though the E4 wristband which participants of both groups wore throughout both appointments and recorded their Heart Rate (HR) and Skin Temperature (ST). At the end of the treatment visit, participants and their parents/legal guardians were asked to complete a feedback questionnaire related to the E4 wristband and the experience of N2O/O2 sedation at the assessment visit.
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- Conditions
- Dental Anxiety
- Being tested
- Experience of nitrous oxide sedation at assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience of nitrous oxide sedation at assessmentBehavioural
Apart from the Lead researcher, a dental nurse assisted with the dental treatment on every appointment. A specially trained sedation nurse was responsible for the monitoring during sedation. The Porter Brown inhalation sedation machine (RA Services, Keighly, W. Yorkshire, UK) was used. Once the appropriate nasal hood was selected, 100% O2 was introduced for 1-2 minutes. Following that, the level of N2O was increased in 10% increments until signs of sedation were observed. The endpoint was between 30-40% nitrous oxide.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only. Receives: Behavioral: Experience of nitrous oxide sedation at assessment |
| Study Group | Experimental | Participants assigned to the study group received assessment with experience of N2O/O2 sedation Receives: Behavioral: Experience of nitrous oxide sedation at assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Child Dental Anxiety Scale
Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data
Measured: At start of recruitment. 4 weeks. 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Richard Balmer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Richard Balmer, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056492
- Sponsor's protocol ID
- ULeeds1
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.
- ClinicalTrials.gov ID
- NCT06056492
- Acronym / sponsor ID
- ULeeds1
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Richard BalmerUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 28 Sep 2023 (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 find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session.
Detailed description
Title: Effectiveness of children experiencing nitrous oxide/oxygen inhalation sedation at an assessment visit before having treatment.
Background: Dental anxiety is a common problem, affecting people of all ages, but predominantly children and adolescents. Inhalation sedation (IHS) using nitrous oxide/oxygen (N2O/O2) mixture is a pharmacological behaviour management technique that is widely used to manage dental anxiety in children. It is suggested that the use of an acclimatisation would increase the acceptability and the efficacy of N2O/O2 success. Even though the introductory appointment has been widely proposed, there have not been any studies conducted to measure the effectiveness of this appointment in improving the success of N2O/O2 sedation in children.
Aims: This study aimed to investigate the effect of experience of nitrous oxide/oxygen sedation at assessment prior to dental inhalation sedation on children's anxiety.
Methods: The study was a parallel randomised non blinded control clinical trial. Children aged five to fifteen years who were seen at the Leeds Dental Institute for dental treatment under inhalation sedation were recruited on the assessment appointment (1st visit). Both two groups received an assessment appointment, however participants of the study group tried on the mask and the nitrous oxide/oxygen sedation while the ones of the control group tried on the mask without the nitrous oxide/oxygen sedation. Following the assessment appointment, both groups received a second appointment for treatment. Dental anxiety was measured through two different methods. Primarily through the MCDASf questionnaire, which was completed once at the beginning of the assessment visit and twice at the beginning and end of the treatment visit. Secondarily anxiety was measured though the E4 wristband which participants of both groups wore throughout both appointments and recorded their Heart Rate (HR) and Skin Temperature (ST). At the end of the treatment visit, participants and their parents/legal guardians were asked to complete a feedback questionnaire related to the E4 wristband and the experience of N2O/O2 sedation at the assessment visit.
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Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Experience of nitrous oxide sedation at assessmentParticipants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only. |
| Study Group | Experimental | Behavioral: Experience of nitrous oxide sedation at assessmentParticipants assigned to the study group received assessment with experience of N2O/O2 sedation |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients attending the Sedation Unit for dental treatment under inhalation sedation.
- Children aged 5 to 15 years.
- ASA Class I or II.
- First time having inhalation sedation.
Key exclusion criteria (3 listed)
- Participants who refuse to wear the mask.
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 |
|---|---|---|
| Experience of nitrous oxide sedation at assessmentApart from the Lead researcher, a dental nurse assisted with the dental treatment on every appointment. A specially trained sedation nurse was responsible for the monitoring during sedation. The Porter Brown inhalation sedation machine (RA Services, Keighly, W. Yorkshire, UK) was used. Once the appropriate nasal hood was selected, 100% O2 was introduced for 1-2 minutes. Following that, the level of N2O was increased in 10% increments until signs of sedation were observed. The endpoint was between 30-40% nitrous oxide. | Behavioural | Control Group, Study Group |
Primary outcome
Modified Child Dental Anxiety Scale
Time frame: At start of recruitment. 4 weeks. 4 weeks.
Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data
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 28 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experience of nitrous oxide sedation at assessment in people with Dental Anxiety, run by Dr Richard Balmer 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 4 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
Modified Child Dental Anxiety Scale (time frame: At start of recruitment. 4 weeks. 4 weeks.). 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 28 Sep 2023.