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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 (Nâ‚‚O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HR | heart rate | immediately after the intervention |
| BP | blood pressure | systolic and diastolic will be assessed immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoxing Maternity and Child Health Care Hospital | Shaoxing | Zhejiang | 312000 | China |
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| psychological support | Behavioral | gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate. |
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| RR | respiratory rate | immediately after the intervention |