Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing

Periodontal Diseases Clinical Trial

— CLOR_3  

Official title:

Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345744
• Other study ID #: CLOR_3
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2020

Study information

• Verified date: November 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontal Pocket
• Surgical Wound

Intervention

Procedure:
• Periodontal surgery
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.

Device:
• Hyaluronic and 0.2% chlorhexidine mouth rinse
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.
• Chlorhexidine 0.2% mouth rinse
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.

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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.2010.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket probing depth (PPD)	Changes in PPD, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and at day 3, day 7, and day 14
Secondary	Clinical attachment level (CAL)	Changes in CAL , measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and at day 3, day 7, and day 14
Secondary	Recession of the gingival margin (REC)	Changes in REC, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and at day 3, day 7, and day 14
Secondary	Bleeding on probing (BOP)	BOP, measured orally through clinical examination. Unit of measure: %	Measured at Baseline
Secondary	Angulated bleeding index (AngBI)	AngBI, measured orally through clinical examination. Unit of measure: %	Measured at day 3, day 7, and day 14
Secondary	Plaque index (PI)	Changes in PI, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and at day 3, day 7, and day 14
Secondary	Periodontal Wound Healing Index (PWHI) (Wachtel classification)	Changes in PWHI, measured orally through clinical examination on all the incisions, assigning a score from 1 to 5.; Score 1: complete wound healing: absence of fibrin line in the interproximal area; Score 2: complete wound healing: presence of a thin fibrin line in the interproximal area; Score 3: complete wound healing: presence of fibrin clot in the interproximal area; Score 4: incomplete wound healing: presence of partial necrosis of the interproximal area; Score 5: incomplete wound healing: total necrosis of the interproximal area	Measured at day 3, day 7, and day 14
Secondary	Post-surgical photographs	Post-surgical photographs will be taken and analysed after the completion of the trial	Taken at Baseline, day 3, day 7, and day 14