Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Brief Summary: This is a randomized controlled clinical trial (RCT). After signing the
      informed consent, patients satisfying the inclusion criteria will undergo supragingival and
      subgingival professional oral hygiene of both arches performed with ultrasonic
      instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine
      powder.

      After that, the sample will be randomly divided into 2 groups based on the domiciliary
      assigned treatment:

        -  Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a
           domiciliary application for 15 days.

        -  Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary
           application for 15 days.

      The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1),
      after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2
      and T3.

      At each recall session were collected a satisfaction questionnaire of the products (taste,
      smell, consistency, persistence and ease of application) and the following periodontal
      clinical indices, using a Periodontal probe on each site:

        -  Gingival Recession (R)

        -  PPD (Probing Pocket Depth),

        -  BOP% (Bleeding on Probing),

        -  CAL (Clinical Attachment Level),

        -  PCR% (Plaque Control Record),

        -  Tooth Mobility.
    

Detailed description: 
      This is a randomized controlled clinical trial (RCT). 40 patients are expected to be
      enrolled. After signing the informed consent, patients satisfying the inclusion criteria will
      undergo supragingival and subgingival professional oral hygiene of both arches performed with
      ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing
      with glycine powder.

      All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department
      of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia.

      After that, the sample will be randomly divided into 2 groups based on the domiciliary
      assigned treatment:

        -  Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a
           domiciliary application for 15 days.

        -  Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary
           application for 15 days.

      The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1),
      after 3 months (T2), and after 6 months (T3).

      At T2 and T3, professional hygiene will be performed again.

      At each recall session were collected a satisfaction questionnaire of the products (taste,
      smell, consistency, persistence and ease of application) and the following periodontal
      clinical indices, using a Periodontal probe on each site:

        -  Gingival Recession (R),

        -  PPD (Probing Pocket Depth),

        -  BOP% (Bleeding on Probing),

        -  CAL (Clinical Attachment Level),

        -  PCR% (Plaque Control Record),

        -  Tooth Mobility.
    

Intervention name(s): Aftoral Oral gel; Unidea Chlorhexidine digluconate mouthwash 0.20%
Intervention type(s): Other; Other
Intervention description(s): Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).; Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment