Treatment of Periodontal Disease With Two Different Bioactive Gels for Home Oral Care
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This study is an open-label split-mouth study in which periodontal patients will be treated
      in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a
      periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in
      periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At
      the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel
      1%. Patients will continue to use gels at home for the following 14 days and on the same
      quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from
      the baseline.

      Patients are divided into two groups with inverted quadrants administration in order to
      evaluate the improvements of periodontal inflammation indices and to assess the efficacy of
      Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.
    

Detailed description: 
      This study is an open-label split-mouth study that aims to assess the improvement of
      periodontal inflammatory indices after sessions of professional oral hygiene with the
      administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also
      compare the efficacy of the two gel in rebalancing periodontal health.

      Periodontal patients that will give the informed consent to the treatment protocol and that
      satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For
      each session, periodontal inflammatory indices will be recorded and professional manual and
      mechanical removal of supragingival and subgingival deposits of both arches will be
      performed, following air-perio polishing with glycine powders. At this stage, patients will
      be randomized and allocated to the following two groups:

        -  Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant
           Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with
           chlorhexidine 1% gel.

        -  Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1%
           gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant
           Bioactive Gel.

      Patients will continue with a home oral care protocol, using both gels for the same quadrants
      of their group for the following 14 days after the professional oral hygiene session.

      The first session is at the baseline (T0), the second is after 1 month (T1), the third is
      after 3 months (T2) and the last is after 6 months (T4).
    

Intervention name(s): Application of Biorepair Gel; Irrigation of Chlorhexidine 1.00% gel
Intervention type(s): Other; Other
Intervention description(s): Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).; Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are divided in two groups. Both groups are treated with non-surgical periodontal therapy (baseline and 1, 3, 6 months after the first professional oral hygiene). Patients in the first group receive Biorepair gel in quadrants Q1 and Q4 and chlorhexidine 1% gel in quadrants Q2 and Q3; for patients in the second group the situation is inverted. In this way, it is possible to compare the general periodontal condition and the quadrants treated with the two different gels.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: split-mouth; periodontal gel; scaling and root planning; periodontal disease; dental hygiene