Comparison of the Silhouette and Porter Brown Systems Used in Inhalation Sedation
Condition: Nitrous Oxide Inhalation Sedation
MeSH terms: Respiratory Aspiration
Study type: Interventional

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 system used for Inhalation Sedation in children having dental treatment at the
      Leeds Dental Institute.

      All eligible participants will be introduced to both masks (Porter Brown and Silhouette) in
      the assessment session prior to their first treatment session. Then participants will be
      randomly allocated to undergo treatment under nitrous oxide-oxygen inhalation sedation using
      either the Porter Brown or the Silhouette System. The efficiency and acceptability will be
      measured by a feedback questionnaire at the end of the treatment session and the scavenging
      efficiency will be measured by a diffusion pen which will measure the levels of nitrous oxide
      in the dentist's environment
    

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 assessment appointment (1st visit). Participants will be randomly assigned
      to two different inhalation sedation breathing masks either the Porter Brown system or the
      Silhouette system on the day of the treatment session (2nd visit) using Block Randomisation.
      It is planned to recruit 4-6 patients every week until 54 participants are reached. On the
      assessment day (1st visit), Information Sheets and the procedures will be explained in
      details to parents and children in simplified language and questions will be answered. All
      participants will be introduced to both masks the Porter Brown system and Silhouette system.
      Then each participant will be given an appointment for the 2nd visit. On the treatment day
      (2nd visit), informed consent/assent will be explained and signed by those who meet the
      eligibility criteria. During the treatment session, a monitoring sheet will be used and data
      will be collected.

      Prior to the start of the study a meeting will be convened with the trained sedation
      assistant and the lead researcher (HA) to explain the study and to introduce the breathing
      systems. 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 besides the first assessment appointment at least two weeks before the first
      visit.

      On the assessment day (1st routine 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 then appointments for the 2nd visit
      will be given for commencement of dental treatment under inhalation sedation for patients who
      agreed to participate in this study. However, for the patients who did not meet the
      eligibility criteria or did not want to participate in the study, they will be given regular
      appointments for their treatment.

      On the day of the treatment ( 2nd routine Visit) informed consent and assent forms will be
      explained and signed by those who met the eligibility criteria. Each participant will be
      treated under Inhalation Sedation using one of two routinely used breathing systems depending
      on the Block Randomization results. he participant will be asked to complete a feedback
      questionnaire related to the mask used which will add about 10 to 15 mins to their routine
      visit. Demographic Data such as Age, Gender and the treatment carried out, the Monitoring
      Data, Behaviour score will be collected from the patient's dental notes.

      At the second visit, each participant will be treated under Inhalation Sedation using either
      the Silhouette or the Porter Brown mask system depending on the session Block Randomization
      results. Before starting the treatment session, each participant will be examined for
      eligibility, If the participant has a blocked nose for example, due to a common cold, he/ she
      will be rescheduled for another visit or otherwise the participant will proceed to have his/
      her treatment session. During the treatment session, the lead researcher (HA) will setup and
      assemble the breathing system parts and choose the correct size of the mask for the patient.
      The lead researcher will also record airflow (including volume, patient breathing rate, and
      level of sedation) and collect participants' data.

      In addition to that, the dental nurse sedation assistant will monitor the participant and
      record the information on the monitoring sheet. After the treatment session, the participant
      will be asked to complete a feedback questionnaire related to the mask used.
    

Intervention name(s): Silhouette breathing system
Intervention type(s): Device
Intervention description(s): The Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose.
Other intervention name(s): Silhouette Mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nitrous oxide Inhalation Sedation; Silhouette Breathing System; Porter Brown Breathing system; Scavenging system; Comparison between two breathing systems; Silhouette Mask; Porter Brown Mask; Dental anxiety; Pediatric dentistry