Comparison between Silhouette and Porter Brown systems in children
Research type
Research Study
Full title
Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation
IRAS ID
233026
Contact name
Haya Alzaabi
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 20 days
Research summary
This study aims to investigate the efficiency of scavenging and patients acceptability of the silhouette system and compare it to the porter brown system. Also the study will look at the differences between the two systems in providing sedation by the dentist.
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 their assessment appointment (1st visit). Participants will be randomly assigned to two different routinely used Inhalation Sedation breathing masks (Porter Brown system or Silhouette system) on the treatment session (2nd visit) using Block Randomisation. It is planned to recruit 4-6 patients every week until 54 participants are reached.
The potential participants will be from the waiting list where patients are waiting for sedation appointments. The lead researcher who is part of the clinical care team will identify and contact those patients by sending them Information Sheets about the study through the post beside the first assessment appointment at least two weeks before the first visit.
On the assessment day (1st visit), Information Sheets and the procedures will be explained in details to parents and children in simple language and questions will be answered. Participants will be introduced to both masks and some of their data will be collected then appointments for the 2nd visit will be given for commencement of dental treatment under inhalation sedation.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0489
Date of REC Opinion
18 Jan 2019
REC opinion
Further Information Favourable Opinion