Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing (CLOR_3)

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Periodontal Pocket
• Intervention / Treatment: Procedure: Periodontal surgery; Device: Hyaluronic and 0.2% chlorhexidine mouth rinse; Device: Chlorhexidine 0.2% mouth rinse

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56121
    • University Hospital of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group 1; administration of a hyaluronic and 0.2% chlorhexidine mouth rinse	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.
Experimental: Test group 2; administration of chlorhexidine 0.2% mouth rinse	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: 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.
Active Comparator: Control Group; No administration of mouth rinses after surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Bleeding on probing (BOP)	BOP, measured orally through clinical examination. Unit of measure: %	Measured at Baseline
Angulated bleeding index (AngBI)	AngBI, measured orally through clinical examination. Unit of measure: %	Measured at day 3, day 7, and day 14
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
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
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

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Mouth Diseases; Periodontitis; Surgical Wound; Periodontal Diseases; Periodontal Pocket; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: CLOR_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No