Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®

NCT ID: NCT06341439

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-02-28

Brief Summary

The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:

• Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy?
• What is the patients' perception?

Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.

Detailed Description

At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary.

Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.

Conditions

Periodontitis

Study Design

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

Study Groups

Test Group

Mouthwash containing 0,12% chlorhexidine + bioflavonoids

Group Type: EXPERIMENTAL

Mouthwash with chlorhexidine 0,12% and CITROX

Intervention Type: DEVICE

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Control Group

Mouthwash containing 0,12% chlorhexidine

Group Type: ACTIVE_COMPARATOR

Mouthwash with chlorhexidine 0,12%

Intervention Type: DEVICE

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Interventions

Mouthwash with chlorhexidine 0,12% and CITROX

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Intervention Type: DEVICE

Mouthwash with chlorhexidine 0,12%

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ASA I and ASA II patients;
• Age > 21 years;
• Non-smokers or smokers < 5 cig/day;
• Presence of periodontal disease;
• >10 natural teeth;
• At least 2 teeth with pockets ≥5mm;
• Indications for carrying out at least one SRP (scaling and root planing) session;
• Signing of the written informed consent to participate in the study.

Exclusion Criteria

• Severe general medical pathologies;
• Immunodeficiency states;
• Radiotherapy in the head and neck region;
• Uncontrolled diabetes or hypertension;
• Smokers >5 cigs/day;
• Impossibility to carry out homogeneous and continuous follow-up;
• Documented allergy to chlorhexidine or hyaluronic acid;
• Taking drugs that cause alterations in the gums and oral mucosa;
• Pregnancy or breastfeeding;
• Presence of removable prostheses;
• Periodontal treatment in the previous 6 months.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Enrico Marchetti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Marchetti, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila

Locations

University of L'Aquila, division of periodontology

L’Aquila, , Italy

Countries

Italy

Other Identifiers

Prot. 001_2023

Identifier Type: -

Identifier Source: org_study_id