Status:
COMPLETED
Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation
Lead Sponsor:
University of Leeds
Conditions:
Nitrous Oxide Inhalation Sedation
Eligibility:
All Genders
7-15 years
Phase:
NA
Brief Summary
This is a randomised non-blinded controlled clinical trial, which involves the measurement of efficiency and acceptability of the Silhouette Mask system and compares it with the Porter Brown Mask syst...
Detailed Description
This study is a "randomised non-blinded controlled clinical trial", where a total of fifty-four patients (n=54) will be recruited from the Sedation Unit (SU) at Leeds Dental Institute on the assessmen...
Eligibility Criteria
Inclusion
- Patients attending the sedation unit for dental treatment under inhalation sedation.
- Children aged 7 to 15 years.
- American Society of Anaesthesiologists classification (ASA) Class I or II.
- Participants who can breathe through their nose/ no upper respiratory tract problems including large adenoids/tonsils.
- Able to follow and comply with instructions.
- First time using inhalation sedation.
Exclusion
- Participants who are not able to communicate directly with the health care personnel carrying out the treatment.
- Uncooperative participants who refuse treatment on the dental chair.
- Participants who can't breathe through their nose (Mouth breathers).
- Participants who refuse to wear the mask.
- American Society of Anaesthesiologists classification ASA III and IV
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04734509
Start Date
February 21 2019
End Date
August 15 2019
Last Update
February 2 2021
Active Locations (1)
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1
Leeds Dental Institute - LTHT
Leeds, West Yorkshire, United Kingdom, LS2 9LU