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

NCT ID: NCT04345744

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-03-31

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.

Conditions

Periodontal Diseases; Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Test group 1

administration of a hyaluronic and 0.2% chlorhexidine mouth rinse

Group Type: EXPERIMENTAL

Periodontal surgery

Intervention Type: 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.

Hyaluronic and 0.2% chlorhexidine mouth rinse

Intervention Type: 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

administration of chlorhexidine 0.2% mouth rinse

Group Type: EXPERIMENTAL

Periodontal surgery

Intervention Type: 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.

Chlorhexidine 0.2% mouth rinse

Intervention Type: 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.

Control Group

No administration of mouth rinses after surgery

Group Type: ACTIVE_COMPARATOR

Periodontal surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Filippo Graziani, DDS MClinDent PhD

Full Professor of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Pisa

Pisa, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 20618550 (View on PubMed)

Other Identifiers

CLOR_3

Identifier Type: -

Identifier Source: org_study_id