Comparison of two mouthwashes for treating gingivitis and preventing periodontitis
Clinical and Microbiological Comparison Between 0.12% Chlorhexidine and 0.05% Chlorhexidine + 0.05% Cetylpyridinium Chloride Mouthwashes in Chemical Biofilm Control During Supportive Periodontal Therapy: A Randomized Clinical Study
NA · University of Siena · NCT06411522
This study is testing which mouthwash works better for people with gingivitis to reduce gum inflammation and help prevent periodontitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Siena (other) |
| Locations | 1 site (Siena) |
| Trial ID | NCT06411522 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two mouthwash formulations, 0.12% chlorhexidine (CHX) and a combination of 0.05% CHX with 0.05% cetylpyridinium chloride (CPC), in reducing gingival inflammation and microbial colonization in patients with gingivitis. Participants will use these mouthwashes at home alongside professional plaque removal over a six-month period. The study aims to identify which formulation is more effective in preventing the recurrence of periodontitis and also evaluates their potential impact on systemic blood pressure. The study is designed to be low-risk for participants, with the main inconvenience being potential tooth enamel darkening, which can be resolved with dental cleaning.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with gingivitis who have some attachment loss and a minimum of 20 teeth.
Not a fit: Patients with allergies to antimicrobials or those on certain systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective mouthwash option for managing gingivitis and preventing periodontitis.
How similar studies have performed: Previous studies have shown positive outcomes with chlorhexidine mouthwashes, making this approach promising but still requiring further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bleeding on probing (BOP) ≥10%, * No more than 4 sites with pocket depth (PPD) \>5mm * Presence of attachment loss (AL) and radiographic bone loss (RBL) * A minimum of 20 teeth Exclusion Criteria: * Intolerance or allergy to antimicrobials * Systemic therapy with anticoagulants/beta-blockers * Local/systemic antibiotic therapy 3 months before * Inability to understand and sign the written informed consent
Where this trial is running
Siena
- AOUS — Siena, Italy (RECRUITING)
Study contacts
- Principal investigator: Nicola Discepoli, DDS MSc PhD — Department of Medical Biotechnologies, University of Siena
- Study coordinator: Nicola Discepoli, DDS MSc PhD
- Email: nicola.discepoli2@unisi.it
- Phone: 3395256148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chlorhexidine, Gingivitis, Periodontitis, Cetylpyridinium Chloride, Prevention