Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients.
Condition: Plaque
Study type: Interventional

Summary: 
      It is more difficult to perform excellent professional oral hygiene in patients wearing
      orthodontic appliances.

      The hypothesis of the present randomized controlled trial is that the application of plaque
      disclosing agent allows better biofilm removal.

      To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study
      groups:

        -  CONTROL GROUP will receive professional oral hygiene without disclosing agent

        -  TEST GROUP will receive professional oral hygiene guided by plaque disclosing agent

      At the end of the professional oral hygiene session, the disclosing agent is re-applied in
      all patients and the percentage of residual plaque area is calculated though image software
      analysis (ImageJ).
    

Detailed description: 
      Oral biofilm is not always visible, so its complete removal can be challenging. Applying a
      plaque disclosing agent before the therapy might serve as a guide to better remove biofilm.
      Thanks to this tool, the clinicians can clearly see where the plaque is, so its removal can
      be more thorough.

      In orthodontic patients, it is even more difficult to remove biofilm and plaque, as the fixed
      appliances pose an obstacle. The hypothesis is that using a plaque disclosing agent as a
      guide to the operator, better removal of the biofilm can be achieved.

      The study will be performed to assess the efficacy of disclosing plaque agent as a guide to
      remove biofilm and plaque in orthodontic patients during professional oral hygiene, performed
      with air-polishing with erythritol powder and a ultrasonic device.

      TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of
      parallel design.The trial will have one-year duration.

      STUDY POPULATION: Orthodontic patients with plaque index above the 25% and without
      periodontal disease.

      PRIMARY OUTCOME: the percentage of area in which the disclosing plaque agent is present after
      the treatment (RPA: Residual Plaque Area).

      RPA: residual plaque area: percentage of area with residual plaque coloured by plaque
      disclosing agent. This will be analysed and calculated with a image analysis software
      (ImageJ).
    

Intervention name(s): Plaque Disclosing Agent; Airpolishing and ultrasonic debridement
Intervention type(s): Diagnostic Test; Device
Intervention description(s): A plaque disclosing agent is applied on teeth to detect plaque. Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.; Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocetric, single blinded, randomized clinical trial, parallel design.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Oral Hygiene; Dental Care; Orthodontic Patient; Disclosing Plaque Agent