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Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experience of nitrous oxide sedation at assessment
Sponsored by
Dr Richard Balmer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Participants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only.

Participants assigned to the study group received assessment with experience of N2O/O2 sedation

Outcomes

Primary Outcome Measures

Modified Child Dental Anxiety Scale
Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data

Secondary Outcome Measures

Full Information

First Posted
September 11, 2023
Last Updated
September 20, 2023
Sponsor
Dr Richard Balmer
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1. Study Identification

Unique Protocol Identification Number
NCT06056492
Brief Title
Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.
Official Title
Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Richard Balmer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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. - 6 -

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants assigned to the control group received assessment without experience N2O/O2 sedation and they tried the mask with O2 only.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants assigned to the study group received assessment with experience of N2O/O2 sedation
Intervention Type
Behavioral
Intervention Name(s)
Experience of nitrous oxide sedation at assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Child Dental Anxiety Scale
Description
Score 8-40. High score is high anxiety. Measured through MCDAS and E$ physiological wristband data
Time Frame
At start of recruitment. 4 weeks. 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LE2 9LU
Country
United Kingdom

12. IPD Sharing Statement

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Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.

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