Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      This is a split-mouth 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 titanium curettes and air
      polishing with glycine powder.

      After that, the following treatment will be randomly assigned:

        -  Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant
           mucositis sites.

        -  Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for
           2 peri-implant contralateral 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, the following periodontal clinical indices were collected using a
      probe on each peri-implant site: BOP, GBI, conditions of the marginal mucosa (swelling and
      erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.
    

Detailed description: 
      This is a split-mouth randomized controlled clinical trial (RCT). 30 patients is 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 titanium
      curettes and air polishing with glycine powder.

      After that, the following treatment will be randomly assigned:

        -  Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant
           mucositis sites.

        -  Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for
           2 peri-implant contralateral 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, the following periodontal clinical indices were collected using a
      probe on each peri-implant site:

      BOP (bleeding on probing) and GBI (gingival bleeding index) Conditions of the marginal mucosa
      (swelling and erythema) Suppuration Migration of the marginal mucosa PD (probing depth) PI
      (plaque index) BS (bleeding score)
    

Intervention name(s): Ozoral Pro and Ozoral gel administration; Curasept chlorhexidine gel 1%
Intervention type(s): Other; Other
Intervention description(s): Peri-implant mucositis sites will receive in-office Ozoral Pro administration after non-surgical therapy. Patients will use Ozoral Gel for the domiciliary administration once a day for 14 days after the visits (no rinsing and eating for 30 minutes after gel application).; Peri-implant mucositis sites will receive in-office Curasept chlorhexidine gel 1% administration after non-surgical therapy. Patients will use chlorhexidine gel 1% for the domiciliary application once a day for 14 days after the visits (no rinsing and eating for 30 minutes after gel application).
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment