The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years

NCT07384988 | Completed Phase 2 DMC

• 1 other identifier: 2023SKY097
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 in reducing pediatric fear and anxiety scores.

Conditions

Dental Anxiety

Keywords

Dental anxiety; Nitrous Oxide

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  From enrollment to the end of treatment at 1 week

Secondary Outcomes (3)

• HR

  immediately after the intervention

• BP

  systolic and diastolic will be assessed immediately after the intervention

• RR

  immediately after the intervention

Study Arms (2)

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.

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.

Drug: Nitrous Oxide Sedation

Interventions

psychological support BEHAVIORAL

gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate.

control group

Nitrous Oxide Sedation DRUG

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.

experimental group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shaoxing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Shaoxing Maternity and Child Health Care Hospital

Shaoxing, Zhejiang, 312000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 3, 2026
• Study Start: January 15, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 8, 2024
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CN (1)