Clinical trial NCT04345744: Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
Official title: Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Periodontal Pocket
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* males or females of age range between 18 and 70 years,
* good health status,
* indication to perform periodontal surgery,
* patients willing to give informed consent,
* compliance to the study follow-up,
* plaque index (PI) score 0 and
* bleeding on probing (BOP) \<25%

Exclusion Criteria:

* pregnancy or breast-feeding,
* therapy with oral contraceptives,
* indication to antibiotic therapy prior to surgical treatment,
* chronic infections,
* systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
* previous therapy with the mouth rinses employed in the present study, and
* smoking habit (\>20 cigarettes per day, and/or pipe or cigar smoking).

Primary outcomes:
measure: Pocket probing depth (PPD)
timeFrame: Measured at Baseline and at day 3, day 7, and day 14
Secondary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: Measured at Baseline and at day 3, day 7, and day 14
measure: Recession of the gingival margin (REC)
timeFrame: Measured at Baseline and at day 3, day 7, and day 14
measure: Bleeding on probing (BOP)
timeFrame: Measured at Baseline
measure: Angulated bleeding index (AngBI)
timeFrame: Measured at day 3, day 7, and day 14
measure: Plaque index (PI)
timeFrame: Measured at Baseline and at day 3, day 7, and day 14
measure: Periodontal Wound Healing Index (PWHI) (Wachtel classification)
timeFrame: Measured at day 3, day 7, and day 14
measure: Post-surgical photographs
timeFrame: Taken at Baseline, day 3, day 7, and day 14
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
References:
citation: Berchier CE, Slot DE, Van der Weijden GA. The efficacy of 0.12% chlorhexidine mouthrinse compared with 0.2% on plaque accumulation and periodontal parameters: a systematic review. J Clin Periodontol. 2010 Sep;37(9):829-39. doi: 10.1111/j.1600-051X.2010.01575.x. Epub 2010 Jul 7.