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

NCT04345744 | Completed

• 1 other identifier: CLOR_3
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical attachment level (CAL)

  Measured at Baseline and at day 3, day 7, and day 14

• Recession of the gingival margin (REC)

  Measured at Baseline and at day 3, day 7, and day 14

• Bleeding on probing (BOP)

  Measured at Baseline

• Angulated bleeding index (AngBI)

  Measured at day 3, day 7, and day 14

• Plaque index (PI)

  Measured at Baseline and at day 3, day 7, and day 14

Study Arms (3)

Test group 1

EXPERIMENTAL

administration of a hyaluronic and 0.2% chlorhexidine mouth rinse

Procedure: Periodontal surgery; Device: Hyaluronic and 0.2% chlorhexidine mouth rinse

Test group 2

EXPERIMENTAL

administration of chlorhexidine 0.2% mouth rinse

Procedure: Periodontal surgery; Device: Chlorhexidine 0.2% mouth rinse

Control Group

ACTIVE COMPARATOR

No administration of mouth rinses after surgery

Procedure: Periodontal surgery

Interventions

Periodontal surgery PROCEDURE

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.

Control Group; Test group 1; Test group 2

Hyaluronic and 0.2% chlorhexidine mouth rinse DEVICE

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.

Test group 1

Chlorhexidine 0.2% mouth rinse DEVICE

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.

Test group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56121, Italy

Location

Related 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.2010.01575.x. Epub 2010 Jul 7.

  PMID: 20618550 RESULT

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Periodontology

Model Details: Single-centre randomized, parallel design, clinical trial with a 2 week follow-up

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2020
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)