Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
Condition: Periodontal Diseases; Periodontal Pocket
MeSH terms: Periodontal Diseases; Periodontal Pocket; Surgical Wound
Study type: Interventional

Summary: 
      Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and
      chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.
    

Detailed description: 
      Patients included in the study will undergo a thorough clinical examination aiming at
      collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and
      presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the
      area selected for periodontal surgery by a single calibrated examiner using a University of
      North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery will be
      performed following a standardized protocol by a single operator.

      After surgery, patients will be randomly assigned to study groups corresponding to mouth
      rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the
      following steps of the study, in order to maintain the examiner blind. The patient will
      receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The
      patient will also be given a diary for the registration of the number of rinses per day, to
      be returned to the examiner at T14. The mouth rinse protocol assigned to each study
      participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

      The patients will be allocated in one of the three distinct study groups as it follows:

        -  Group A: no administration of mouth rinses after surgery (control group)

        -  Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group
           1)

        -  Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).

      Post-treatment photographs of surgical incision will be taken immediately after periodontal
      surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of
      the degree of wound healing. The degree of surgical healing will be evaluated using the
      Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score
      from 1 to 5 will be assigned.

      At T3, T7, and T14 the following clinical parameters will be recorded for each tooth in the
      surgical area: PPD, Rec, PI, and BOP. The clinical examinations will be performed by
      calibrated examiner blind to group allocation.
    

Intervention name(s): Periodontal surgery; Hyaluronic and 0.2% chlorhexidine mouth rinse; Chlorhexidine 0.2% mouth rinse
Intervention type(s): Procedure; Device; Device
Intervention description(s): Surgery will be performed following a standardized protocol by a single operator (FG). The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.; The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.; The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care