Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

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 with PEEK
      inserts, manual instrumentation with PEEK 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 for
           the domiciliary use for 15 days for 2 peri-implant mucositis sites.

        -  Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary
           application for 15 days for 2 peri-implant sites.

      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 PEEK probe on each peri-implant site:

        -  conditions of the marginal mucosa (swelling and erythema),

        -  migration of the marginal mucosa,

        -  PPD (Probing Pocket Depth),

        -  BOP% (Bleeding on Probing),

        -  BS (Bleeding Score),

        -  Suppuration,

        -  PCR% (Plaque Control Record),
    

Detailed description: 
      This is a randomized controlled clinical trial (RCT). 60 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 with PEEK inserts, manual instrumentation with PEEK 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 for
           the domiciliary use for 15 days for 2 peri-implant mucositis sites.

        -  Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary
           application for 15 days for 2 peri-implant sites.

      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 PEEK probe on each peri-implant site:

        -  conditions of the marginal mucosa (swelling and erythema),

        -  migration of the marginal mucosa,

        -  PPD (Probing Pocket Depth),

        -  BOP% (Bleeding on Probing),

        -  BS (Bleeding Score),

        -  Suppuration,

        -  PCR% (Plaque Control Record).
    

Intervention name(s): Aftoral Oral Gel; Unidea Chlorhexidine mouthwash
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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyaluronic acid; chrlorhexidine; non-surgical periodontal therapy