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 mouthwash containing Citrox is used?
• 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: Active, not recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: Mouthwash with chlorhexidine 0,12% and CITROX; Device: Mouthwash with chlorhexidine 0,12%

• 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 > 25 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
Active Comparator: Control Group	Device: Mouthwash with chlorhexidine 0,12%; Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
Experimental: Test Group	Device: Mouthwash with chlorhexidine 0,12% and CITROX; 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
Probing Depth (PD)	Effects on post-treatment healing: the Probing Depth was measured in mm	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)	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)	6 months
Full mouth plaque score (FMPS)	The FMPS indicate the percentage of sites with plaque out of the total.	6 months
Full mouth bleeding score (FMBS)	The FMBS indicate the percentage of bleeding sites out of the total.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome Measure (PROMS)	Visual Analogue Scale (SCALE) 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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): January 18, 2024
• Study Completion (Estimated): March 30, 2024

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): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Randomized trial; Plaque; Chlorhexidine; Mouthwash; Non-surgical therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; 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 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