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The effect of an inhalation sedation familiarization visit on children’s dental behavior

A single-center investigator-blinded randomized parallel-group study to investigate the effect of an acclimatization visit on children’s behavior during inhalation sedation in a United Arab Emirates pediatric dentistry postgraduate setting

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46437306
Enrollment
60
Registered
2019-03-28
Start date
2019-05-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental anxiety in children Oral Health

Interventions

After baseline examination by the clinical team, eligibility verification, participant’s assent and parents’/guardian’s consent submission, participants will be randomized to the two study groups (30

Sponsors

Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy children aged 5-15 years in need of dental treatment under inhalation sedation 2. No learning disabilities 3. Suitable for nitrous oxide/oxygen inhalation sedation (IHS) 4. United Arab Emirates (UAE) and non-UAE nationals’ parents and children will be eligible to participate in the study

Exclusion criteria

Exclusion criteria: 1. Children with special healthcare needs and/or medically compromised 2. Children who their parents refuse to consent 3. Those with complex medical histories ASA III and ASA IV 4. Children with a known diagnosed psychiatric disorder 5. Children younger than five years and older than 15 years

Design outcomes

Primary

MeasureTime frame
Behavior and anxiety levels: 1. Physiological parameters measured by: 1.1. The E4 wrist band during the second (treatment) visit, which is approximately one week after the initial visit. The child will wear the watch for 15 minutes prior to dental treatment while sitting with parent/guardian in the waiting room and continuously during the treatment session (Added 23/07/2019) 1.2. Salivary amylase and salivary cortisol levels measured using Expanded Range High Sensitivity Salivary Amylase and Cortisol Enzyme Immunoassay Kit at the beginning of the initial visit, 15 minutes before the start of second visit treatment, and 15 minutes after the completion of second visit treatment 2. Anxiety scores using a component from the Indicator of Sedation Need (IOSN) at baseline (initial visit) and after treatment (second visit) 3. Behaviour score recorded using Frankl behaviour rating scale at the end of initial (first) visit and end of second treatment visit

Secondary

MeasureTime frame
The beneficial effect of the acclimatization inhalation sedation visit, assessed using: 1. Satisfactory completion of the required dental treatment at the end of second visit 2. Children’s and parents’ acceptance of dental treatment with or without acclimatization visit at the end of second visit Measured using guardian/child quantitative questionnaire and records from clinical notes

Countries

United Arab Emirates, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026