Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04345744
Study type	Interventional
Source	University of Pisa
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	March 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms