Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis.
Condition: Periodontitis, Aggressive; Periodontal Diseases; Periodontitis
MeSH terms: Periodontitis; Periodontal Diseases; 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 aim of this randomized, controlled, split-mouth study was to compare the efficacy of
      full-mouth air-polishing followed by ultrasonic debridement (GBT) versus traditional Scaling
      and Root Planing (SRP), in terms of pocket closure in patients with stage III-IV
      periodontitis.

      To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in
      2 parts:

        1. The control group undergoing a standard procedure: ultrasonic debridement with an
           ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with
           curettes at deep pathological pockets (PPD > 4mm) and rubber cup with polishing to
           remove supra gingival biofilm and plaque.

        2. The study group undergoing the innovative air polishing procedure: airflow with
           erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow at deep
           pathological pockets (PPD > 4mm) and ultrasonic debridement with an ultrasonic scaler
           for remove supra and sub gingival calculus.

      The prevalence of residual pockets will be evaluated at 6 weeks and 3 months after the
      initial therapy and compared between the two groups.
    

Detailed description: 
      TRIAL DESIGN:

      A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.

      OUTCOME:

        1. The primary outcome was the number of experimental sites (PPD >4mm and <10mm) becoming
           closed pockets (PPD ≤ 4mm) at 6 weeks (T1) and 3 months (T2) after initial therapy.

        2. Secondary outcomes were the variations in PPD, REC (Clinical Gingival Recession), CAL
           (Clinical Attachment Level), BOP (Bleeding On Probing) and PI (Plaque Index) at the
           experimental sites and treatment time.

      A 10% difference in the primary outcome between the two protocols was set as the threshold to
      define inferiority/non-inferiority of the Test treatment.

      STUDY POPULATION:

      thirty-two (32) adults, aged 18-75 years, will be entered into study (randomized).

      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 CRITERIA:

        -  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).

        -  Diagnosis of Stage III-IV periodontitis;17

        -  At least 6 sites per quadrant with Pocket Probing Depth (PPD) ≥ 3mm;

        -  At least 5 teeth per quadrant;

        -  Availability for the 3-month duration of the study for an assigned subject.
    

Intervention name(s): Airflow, Perioflow and Erythritol powder and ultrasonic debridement; Ultrasonic debridement and curettes
Intervention type(s): Device; Device
Intervention description(s): Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy; traditional Scaling and Root Planing with curettes and ultrasonic scaler
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split Mouth, RCT
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Periodontitis; Biofilm; Air-polishing; SRP; Ultrasonic