A Randomised Controlled Clinical Trial on the Use of a Dental Aerosol Box to Prevent Microbial Transmission During Dental Procedure
Condition: Calculi
MeSH terms: Calculi
Study type: Interventional

Summary: 
      The study compares the use of a dental aerosol box in preventing microbial transmission
      during dental procedure. Subjects requiring scaling treatment (BPE 2) will be recruited.
      Subjects will be allocated either into the control group (conventional suction method) or
      interventional group (dental aerosol box) Treatment will involve scaling of two quadrants,
      where data collection of the microbes will be taken. Secondary outcome will involve a
      self-administered questionnaire on patients acceptance over the scaling procedure either with
      conventional suction or using the dental aerosol box to contain the aerosol generated during
      the scaling procedure.
    

Detailed description: 
      A closed operation room, with the facility to fumigate the room is chosen for all treatment
      procedures. Patients would be treated with time separations that would be reasonable to
      prevent microbial detection of the previous patient.

      Sample size calculated based on Sadun et al (2020) to compare two groups would require 15
      subjects per group for a 90% power and 0.05 significance.

      Inclusion criteria: BPE 2 on at least 2 quadrants. Exclusion criteria: Smoker and systemic
      disease.

      Patients will be randomised using randomiser.org. The list will be placed in a sealed envelop
      by an individual not involved in subject recruitment. Patient grouping will be determined
      after recruitment and consent. The envelop will be opened and patient allocated to the group.

      Interventional group:

        1. Conventional suction (control)

        2. Dental aerosol box with modified high-volume evacuation system (interventional)

      The procedure will involve scaling of two quadrants, where data collection of the microbes
      will be taken.

      Before each appointment, at the start of study all operatory surfaces were cleaned and
      disinfected with Ethyl alcohol (70%). Between each treatment and at start of treatment,
      ultrasonic scaler units will be flushed with water for 2 minutes. Use of 0.5% Sodium
      Hypochlorite will be done for flushing the tubing of dental chair waterline and the same
      solution would be allowed to stay in tubing for 10 minutes followed by water flushing to
      remove the unwanted biofilm from the tubing surfaces. This procedure would be done at the end
      of each treatment.

      Then operatory will fumigated at the end of all procedures to allow the room to be free of
      aerosol before it is allowed for use for the subsequent subject. Dental unit would use
      distilled water in self-contained system, for the study.

      i) Primary outcome: microbial colony forming unit Passive sampling will be conducted to
      assess the index of microbial air contamination as described in other studies (Pasquarella C,
      et al 2000, Napoli C, et al 2012, Saha R, et al 2017). The method quantifies the microbial
      flow directly related to the contamination of surfaces coming from microbes that reach
      critical points by falling on to them. The index of microbial air contamination is based on
      the count of the microbial fallout on to Petri dishes left open to the air according to the
      1/1/1 scheme (for 1h, 1m from the floor, at least 1m away from walls or any obstacle). This
      index corresponds to the values of CFU calculated from the culture plates of 9 cm diameter.
      Sealed petri dishes will be transported to where the procedures will be done. Gravity settle
      plates using tryptic soy agar in 9cm Petri dishes will be used to assess the colony count for
      passive sampling. The index of microbial air contamination will be assessed at rest (in the
      early morning before the beginning of dental procedures) and in operational of procedures
      (during procedures) to determine changes in bacterial count due to dental treatment. Five
      resting and five in operational samples will be taken from each room. Plates will be
      incubated overnight at 37°C and colony counts will be documented.

      ii) Secondary outcome: patient acceptance Patient will complete a self-administered
      questionnaire to determine their acceptance over the experience to undergo the scaling
      procedure.
    

Intervention name(s): Conventional suction system; Dental aerosol box with modified high volume evacuation system
Intervention type(s): Device; Device
Intervention description(s): This is the conventional method of using the dental high volume suction to contain the aerosol generated during dental procedure. The saliva ejector will also be used.; The dental aerosol box will be equipped with an exit for the high volume suction to be attached to contain the aerosol generated during dental procedure. The saliva ejector will also be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control - conventional suction system Interventional - dental aerosol box with modified high volume evacuation suction system
Masking: None (Open Label)
Primary purpose: Prevention