The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study.
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Traditional methods for plaque and calculus removal involve the use of mechanical and/or
      manual instruments, followed by surface polishing with rubber cups and low abrasive pastes.
      These instruments may cause the unintended removal of hard dental tissue, such as enamel,
      cementum and dentine, increasing surface roughness. Moreover, they can lead to gingival
      recession and consequent hypersensitivity and discomfort during treatment. New
      minimally-invasive approaches to biofilm removal have been recently introduced with the aim
      to limit the negative impact on the oral tissue. Air-polishing with low-abrasiveness powders
      are proven suitable for both for supra- and sub-gingival plaque removal. The use of
      low-abrasiveness powders could lead to several advantages, such as reduction of treatment
      discomfort, shorter treatment time, the possibility of cleaning areas with difficult access
      and minor damage on soft and hard tissues.

      Aim: the aim of this study is to evaluate the efficacy of the Full Mouth Erithrytol Powder
      Air-Polishing Therapy compared to traditional ultrasonic debridment (UD) and polishing in
      patient affected by gingivitis.

      Test hypotesis: there is no difference in clinical outcome between two methods against the
      hypothesis of a difference in terms of changes in Blending on Probing (BOP).

      To test this hypothesis, the patients, upon initial evaluation, were treated in split mouth:

        -  The control group undergoing the standard procedure with full-mouth ultrasonic
           debridement and polishing with rubber cup and abrasive paste.

        -  The study group undergoing an innovative procedure involving full-mouth air-polishing
           followed by ultrasonic calculus removal.

      Follow-ups are scheduled at 2 weeks and 1, 3, 6 and 12 months.
    

Detailed description: 
      TRIAL DESIGN:

      Mono-centric, pragmatic, double-blinded, randomized clinical trial (RCT) with split-mouth
      design. The trial will have a one year of duration.

      PRIMARY OUTCOME:

      - Change in BoP: change in percentage of sites positive to bleeding on probing.

      SECONDARY OUTCOMES:

        -  Change in Plaque Index (PI): change in percentage of sites with presence of plaque.
           Baseline values will be compared to the values recorded at follow-up visits.

        -  Change in Residual Plaque Area (RPA): Post-treatment percentage of tooth area with
           residual plaque, visualised via plaque disclosing agent. This will be calculated with
           computer software analysis (ImageJ) on clinical photographs.

        -  Change in Periodontal Attachment Level (PAL): change in mean value for each patient will
           be calculated. Baseline values will be compared to the values recorded at follow-up
           visits.

        -  Change in (Pocket Probing Depth) PPD: change in mean value for each patient will be
           calculated. Baseline values will be compared to the values recorded at follow-up visits.

        -  Duration of the treatment: calculated in minutes. Time will be recorded starting from
           the opening the randomisation envelope until the clinician is satisfied with the
           clinical result.

        -  Comfort of the patient: an anonymous questionnaire will be administered at baseline and
           each recall appointment.

        -  Sensation of cleanliness: an anonymous questionnaire will be administered at baseline
           and each recall appointment.

      STUDY POPULATION:

      41 Systemically healthy patients affected by gingivitis will be included in this study.
      Presence of gingivitis is defined as: absence of Probing pocket depth (PPD) > 4mm and
      presence of BoP >25%.

      INCLUSION CRITERIA:

        -  Patients affected by gingivitis (BoP >25%);

        -  Patients with at least 5 teeth per quadrant;

        -  Systemically healthy;

        -  Age > 18 years;

        -  Smoking less than 10 cigarettes a day.
    

Intervention name(s): AIRFLOW® with PLUS® powder and PIEZON® scaler; PIEZON® scaler and rubber cup with abrasive paste
Intervention type(s): Device; Device
Intervention description(s): Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling; Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gingivitis; GBT; Ultrasonic debridement