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

Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® as a Support to Non-surgical Periodontal Therapy: a Randomized Controlled Triple-blind Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: Mouthwash with chlorhexidine 0,12% and CITROX; Device: Mouthwash with chlorhexidine 0,12%

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • University of L'Aquila, division of periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Mouthwash containing 0,12% chlorhexidine + bioflavonoids	Device: Mouthwash with chlorhexidine 0,12% and CITROX; Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
Active Comparator: Control Group; Mouthwash containing 0,12% chlorhexidine	Device: Mouthwash with chlorhexidine 0,12%; Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth bleeding score (FMBS)	The FMBS indicate the percentage of bleeding sites out of the total.	baseline, 14 days, 2 months, 6 months
Full mouth plaque score (FMPS)	The FMPS indicate the percentage of sites with plaque out of the total.	baseline, 14 days, 2 months, 6 months
Probing Depth (PD)	Effects on post-treatment healing: the Probing Depth was measured in mm	baseline, 2 months, 6 months
Gingival Index (GI)	Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)	baseline, 14 days, 2 months, 6 months
Plaque Index (PI)	Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)	baseline, 14 days, 2 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome Measure (PROMS)	Visual Analogue Scale (VAS) in the form of a questionnaire to evaluate post-op pain, post-op sensitivity, taste alteration, appearance of staining and pleasantness of the mouthrinse used. The minimum value is 0 while the maximum value is 10. For all questions the best value is 0 and the worst 10, except for pleasantness.	2 weeks post non-surgical periodontal therapy

Collaborators and Investigators

• Sponsor: University of L'Aquila
• Investigators: Principal Investigator: Enrico Marchetti, DDS, MS, PhD, University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Periodontitis; Randomized trial; Plaque; Chlorhexidine; Mouthwash; Non-surgical therapy
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Anti-Infective Agents; Dermatologic Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Prot. 001_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD could be available to other researchers. Data will anonymized and delivered under request.
• IPD Sharing Time Frame: Under request.
• IPD Sharing Access Criteria: The team will have the possibility to choose if the request come from a reliable source.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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