Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis
Condition: Periodontitis, Adult; Periodontitis, Aggressive
MeSH terms: Periodontitis; Chronic Periodontitis; Aggressive Periodontitis
Study type: Interventional

Summary: 
      The first step in the management of periodontal disease involves the non-surgical removal of
      the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into
      deep pockets, which can be carried on with different instruments. Unfortunately it seems
      that, after the initial therapy, many patients still present with active pockets (residual
      pockets) requiring further treatment and posing a risk of disease progression. This might be
      due to limitations of the instruments applied and patient-related factors. Air-polishing with
      low-abrasiveness powders seems to be very effective in the removal of supra- and sub-gingival
      biofilm and could provide additional benefits during the treatment of pockets.

      The hypothesis of the present randomized controlled trial was that the adjunctive use of a
      sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of
      5-9mm and with bleeding (experimental sites) can bring clinical and microbiological
      advantages during the active therapy of periodontal disease, and reduce the number of
      residual pockets.

      To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study
      groups:

        1. The control group, undergoing a standard procedure involving air-polishing
           supra-gingivally and at healthy sub-gingival sites followed by debridement with an
           ultrasonic scaler at deep pathological pockets

        2. The study group, undergoing the same procedure but with the additional use of a
           sub-gingival nozzle at deep pathological pockets.

      The healing of the experimental sites and the prevalence of residual pockets will be
      evaluated at 3 months after the initial therapy and compared between the two groups.
    

Detailed description: 
      OUTCOME

        1. Primary outcome measure: 3-month change in the number of sites with probing depth (PD)
           5-9 mm and positive to bleeding upon probing (BoP). Sites characterized by PD 5-9 mm and
           BoP+ will be therefore identified as "experimental sites".

        2. Secondary outcomes: 3-month changes in the following clinical parameters assessed at
           experimental sites: clinical attachment level (CAL), PD, number of sites harboring
           supra-gingival plaque.

        3. Other evaluations: Pocket microbiological (subgingival plaque) samples at one
           (interproximal) experimental site for analysis of periodontal pathogens at baseline and
           3 months following treatment.

      STUDY POPULATION Forty (40) adults, aged 18-75 years, will be entered into study
      (randomized). It is expected that at least thirty-two (32) subjects will complete the study.

      Randomized subjects who deviate from the protocol (major protocol deviation) and, for this
      reason, are excluded from the analysis, will be replaced to guarantee that the sample
      required for the analysis (32) is reached.

      Inclusion Characteristics

        -  Signed Informed Consent Form.

        -  Male and female subjects, aged 18-75 years, inclusive.

        -  Good general health (free of systemic diseases such as diabetes, HIV infection or
           genetic disorder, ongoing malignant disease of any type that could influence the outcome
           of the treatment and might interfere with the evaluation of the study objectives).

        -  Moderate to severe periodontitis

        -  At least 8 experimental sites (PD 5-9 mm and BoP+).

        -  Availability for the 3-month duration of the study for an assigned subject.
    

Intervention name(s): Perioflow and Erythritol powder and ultrasonic debridement; Airflow and Erythritol powder and ultrasonic debridement
Intervention type(s): Device; Device
Intervention description(s): Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy; Airflow combined with Erythritol powder will be used as an adjunct therapy
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-Arm, Examiner-Blinded, RCT
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Guided Biofilm Therapy; Periodontitis; Erythritol