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

NCT06341439 | Completed

• 1 other identifier: Prot. 001_2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Periodontitis; Non-surgical therapy; Chlorhexidine; Mouthwash; Plaque; Randomized trial

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Patient Reported Outcome Measure (PROMS)

  2 weeks post non-surgical periodontal therapy

Study Arms (2)

Test Group

EXPERIMENTAL

Mouthwash containing 0,12% chlorhexidine + bioflavonoids

Device: Mouthwash with chlorhexidine 0,12% and CITROX

Control Group

ACTIVE COMPARATOR

Mouthwash containing 0,12% chlorhexidine

Device: Mouthwash with chlorhexidine 0,12%

Interventions

Mouthwash with chlorhexidine 0,12% and CITROX DEVICE

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

Test Group

Mouthwash with chlorhexidine 0,12% DEVICE

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

Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila, division of periodontology

L’Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Periodontitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Marchetti, DDS, MS, PhD

  University of L'Aquila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: February 28, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Under request.
• Access Criteria: The team will have the possibility to choose if the request come from a reliable source.

Locations

IT (1)