Dental AnxietyPhase 2N₂ONCT07384988
The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years
A Phase 2 study testing Nitrous Oxide Sedation and psychological support in people with Dental Anxiety, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
Trial summary
Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Nitrous Oxide Sedation and psychological support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 8 Sep 2024
- Phase
- Phase 2
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.Aged 6-10 years; 2.Classified as American Society of Anesthesiologists (ASA) physical status I-II; 3.Required dental treatments such as caries filling, pulp therapy, or tooth extraction; 4.Informed consent obtained from the child's guardian.
Who cannot join
- 1.Contraindications to nitrous oxide inhalation, such as severe cardiopulmonary dysfunction, intestinal obstruction, or pneumothorax; 2.Mental illness or intellectual disability that would hinder cooperation with assessments or treatment; 3.Received dental sedation or general anesthesia within the past month;
Trial locations and contacts
1 site in 1 country.
China1 site
Shaoxing Maternity and Child Health Care Hospital
Shaoxing, Zhejiang, 312000
About this study
Official title: The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years: A Randomized Controlled Clinical Trial
Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.
Read the detailed description
This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.
- Conditions
- Dental Anxiety
- Being tested
- Nitrous Oxide Sedation, psychological support
- Keywords
- Dental anxiety, Nitrous Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide SedationDrug
After the child was seated in the dental chair, an appropriately sized nasal mask was selected to ensure a secure fit without leakage. The child initially inhaled 100% oxygen for 3-5 minutes to adapt to the breathing pattern and eliminate nitrogen from the lungs. Nitrous oxide was then introduced at an initial concentration of 10%-15%, with adjustments made in increments of 5%-10% based on the child's anxiety level, treatment stimuli, and vital signs. Each adjustment was followed by 1-2 minutes of observation until the desired level of sedation was achieved.
psychological supportBehavioural
gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | The control group received only conventional local anesthesia and psychological comfort measures. Preoperatively, medical staff communicated thoroughly with the child and guardian to explain the treatment process and precautions, alleviating anxiety. The child's oral and systemic health was assessed to determine treatment difficulty. During treatment, articaine (Septodont, France) were administered under strict aseptic techniques to minimize pain. Continuous psychological support was provided through gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate. Postoperatively, the child was observed for any adverse reactions before being discharged with their guardian. Receives: Behavioral: psychological support |
| experimental group | Experimental | The experimental group received nitrous oxide anesthesia using a professional dental nitrous oxide inhalation sedation system (Matrx, the United States). This system featured precise gas concentration adjustment, real-time patient vital sign monitoring, and a reliable alarm system to ensure accurate, safe, and stable nitrous oxide administration. Receives: Drug: Nitrous Oxide Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDAS
The Modified Dental Anxiety Scale, zero is equivalent to no anxiety and 5 indicates the worst possible anxiety, participants achieved a response if they scored a performance status of 0 on a scale ranging from 0 (best outcome) to 5 (worst outcome)
Measured: From enrollment to the end of treatment at 1 week
Behavioral Observation Scale
The Frankl behavior rating scale was used to assess the children's behavior during treatment. This 4-point scale categorizes behavior , participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 4 (worst outcome)
Measured: From enrollment to the end of treatment at 1 week
CFSS-DS
Children's Fear Survey Schedule-Dental Subscale, participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 5 (worst outcome)
Measured: From enrollment to the end of treatment at 1 week
Secondary outcomes (3)
HR
heart rate
Measured: immediately after the intervention
BP
blood pressure
Measured: systolic and diastolic will be assessed immediately after the intervention
RR
respiratory rate
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start15 Jan 2024
- Primary completion31 Aug 2024
- Study completion8 Sep 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoxing Maternity and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Renjie, Shaoxing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384988
- Sponsor's protocol ID
- 2023SKY097
- Acronym
- N₂O
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07384988
- Acronym / sponsor ID
- N₂O / 2023SKY097
- Conditions
- Dental Anxiety
- Keywords
- Dental anxiety, Nitrous Oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaoxing Maternity and Child Health Care HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 3 Feb 2026 (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.
Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.
Detailed description
This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Behavioral: psychological supportThe control group received only conventional local anesthesia and psychological comfort measures. Preoperatively, medical staff communicated thoroughly with the child and guardian to explain the treatment process and precautions, alleviating anxiety. The child's oral and systemic health was assessed to determine treatment difficulty. During treatment, articaine (Septodont, France) were administered under strict aseptic techniques to minimize pain. Continuous psychological support was provided through gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate. Postoperatively, the child was observed for any adverse reactions before being discharged with their guardian. |
| experimental group | Experimental | Drug: Nitrous Oxide SedationThe experimental group received nitrous oxide anesthesia using a professional dental nitrous oxide inhalation sedation system (Matrx, the United States). This system featured precise gas concentration adjustment, real-time patient vital sign monitoring, and a reliable alarm system to ensure accurate, safe, and stable nitrous oxide administration. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1.Aged 6-10 years; 2.Classified as American Society of Anesthesiologists (ASA) physical status I-II; 3.Required dental treatments such as caries filling, pulp therapy, or tooth extraction; 4.Informed consent obtained from the child's guardian.
Key exclusion criteria (1 listed)
- 1.Contraindications to nitrous oxide inhalation, such as severe cardiopulmonary dysfunction, intestinal obstruction, or pneumothorax; 2.Mental illness or intellectual disability that would hinder cooperation with assessments or treatment; 3.Received dental sedation or general anesthesia within the past month;
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 |
|---|---|---|
| Nitrous Oxide SedationAfter the child was seated in the dental chair, an appropriately sized nasal mask was selected to ensure a secure fit without leakage. The child initially inhaled 100% oxygen for 3-5 minutes to adapt to the breathing pattern and eliminate nitrogen from the lungs. Nitrous oxide was then introduced at an initial concentration of 10%-15%, with adjustments made in increments of 5%-10% based on the child's anxiety level, treatment stimuli, and vital signs. Each adjustment was followed by 1-2 minutes of observation until the desired level of sedation was achieved. | Drug | experimental group |
| psychological supportgentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate. | Behavioural | control group |
Primary outcome
MDAS
Time frame: From enrollment to the end of treatment at 1 week
The Modified Dental Anxiety Scale, zero is equivalent to no anxiety and 5 indicates the worst possible anxiety, participants achieved a response if they scored a performance status of 0 on a scale ranging from 0 (best outcome) to 5 (worst outcome)
Behavioral Observation Scale
Time frame: From enrollment to the end of treatment at 1 week
The Frankl behavior rating scale was used to assess the children's behavior during treatment. This 4-point scale categorizes behavior , participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 4 (worst outcome)
CFSS-DS
Time frame: From enrollment to the end of treatment at 1 week
Children's Fear Survey Schedule-Dental Subscale, participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 5 (worst outcome)
3 secondary outcomes
HR
Time frame: immediately after the intervention
BP
Time frame: systolic and diastolic will be assessed immediately after the intervention
RR
Time frame: immediately after the intervention
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 3 Feb 2026.
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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 Phase 2 study testing Nitrous Oxide Sedation and psychological support in people with Dental Anxiety, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
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 1 inclusion and 1 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 3 Feb 2026. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MDAS (time frame: From enrollment to the end of treatment at 1 week). The study lists 3 primary outcomes in all. 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 3 Feb 2026.