Effect of Stress on Periodontal Therapy (NPT)
Condition: Stress, Psychological; Periodontal Diseases; Periodontitis; Non Surgical Periodontal Therapy; Inflammation; Bleeding on Probing
MeSH terms: Periodontitis; Periodontal Diseases; Inflammation; Stress, Psychological
Study type: Interventional

Summary: 
      Aim of this study:

      is to evaluate the influence of stress level on the response of non surgical periodontal
      therapy in patients affected by severe periodontitis divided into "Medium/High stress level"
      or "Low stress level" based on the Perceived Stress Scale (PSS). The defined primary outcome
      referring to the clinical response of the patients is the bleeding index, Full-Mouth Bleeding
      Score (FMBS), as a clinical sign of inflammation.

      Materials and Methods:

      Monocentric prospective triple blinded study. A single evaluator conducting all the
      psychologic tests, a single operator blinded to the results of the psychologic tests doing
      all the clinical measurements, and the patients will be initially blinded to the category of
      stress that they'll belong to. The minimum number of patients to enrol will be 89 based on a
      sample calculation.

      Inclusion Criteria:

      Patients must meet all of the following inclusion criteria to be eligible for enrollment into
      the study:

      Age from 20 to 80 years Diagnosis of Periodontitis stage III/IV according to the new
      classification (2018); Presence of at least 14 teeth, with a minimum of 10 sites with PD at
      least > 5 mm and radiographic evidence of alveolar bone loss.

      Written informed consent

      Exclusion Criteria.

      The presence of any of the following will exclude a subject from study enrollment:

      Smokers > 10 cig/die Patients with orthodontic appliances; Pregnant or lactating women;
      Individuals who have received periodontal treatment in the 6 months prior to recruitment;
      Patients with systemic diseases that could interfere the clinical response to periodontal
      treatment (i.e. diabetes); Subjects under treatment with antibiotics, steroidal and/or
      non-steroidal anti-inflammatory medication 3 weeks prior to the visit and patients treated
      with antiepileptic drugs

      Operative procedure:

      Clinical parameters and psychologic test will be done at the baseline. All the patients will
      be treated by means of non surgical periodontal therapy on a quadrant protocol including oral
      hygiene instructions and motivations and subgingival instrumentation in four successive
      visits. 6 weeks after the last visit, the clinical parameters will be registered again.

      Clinical Parameters:

      Periodontal condition of each patient will be evaluated through the collection of the
      following parameters:

        -  Full-Mouth Bleeding score (FMBS): presence/absence of bleeding on probing using a
           periodontal probe on each surface of the tooth (six sites per tooth), calculated in
           percentage for all the examined teeth.

        -  Full-Mouth Plaque Score (FMPS): presence/absence of plaque using a periodontal probe on
           each surface of the tooth (six sites per tooth), calculated in percentage for all the
           examined teeth.

        -  Probing Depth (PD): measured for each surface of the tooth (six sites per tooth) using a
           periodontal probe, measured as the distance between the cementoenamel junction (CEJ) and
           the depth of the pocket.

        -  Gingival recession (Rec): measured for each surface of the tooth (six sites per tooth)
           using a periodontal probe, measured as the distance between the cementoenamel junction
           (CEJ) and the free gingival margin.

        -  Clinical attachment level (CAL): The sum of PD and Rec.

      Psychologic Test:

      The Stress condition of each patient will be assessed by a Psychologist using:

      PSS is a 10-items self-report questionnaire that measure the degree to which situations in
      one's life are appraised as stressful. The PSS is scored on a 5-point scale (never, almost
      never, sometimes, fairly often and very often). PSS norms are available from a sample of the
      USA collected by Cohen & Williamson (1988). The mean level for men was 12.1 (S.D. 5.9) and
      for women 13.7 (S.D. 6.6).
    


Intervention name(s): Non Surgical Periodontal Therapy
Intervention type(s): Procedure
Intervention description(s): Conventional staging debridement (CSD) according to the severity of periodontal disease in 2 to 4 appointments at day 0, 7, 14 and 21.
Supra and subgingival scaling and polishing will be performed by the use of manual and ultrasonic instruments and oral hygiene instructions will be given. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment