Cetylpyridinium Chloride, Chlorhexidine, Gingivitis, Periodontitis
Conditions
Keywords
Prevention
Brief summary
The present study compares the effectiveness of two mouthwash formulations (0.12% CHX and 0.05% CHX+0.05%CPC) in reducing gingival inflammation and microbial colonization in individuals with gingivitis and in preventing periodontitis recurrence. The main focus is on assessing the clinical impact of the mouthwashes over six months, with a secondary goal of evaluating their effect on systemic blood pressure.
Detailed description
This study aims to assess the impact of at-home use of 0.05% CPC + 0.05% chlorhexidine or 0.12% chlorhexidine, combined with professional plaque removal, on gingival inflammation and microbial quantity and quality in individuals diagnosed with gingivitis and reduced periodontium. It seeks to identify the most effective mouthwash formulation for reducing microbial colonization and preventing periodontitis recurrence. Comparing the commonly used 0.12% chlorhexidine with the alternative formulation of 0.05% chlorhexidine + 0.05% CPC over one month, with no reported side effects, is the main focus. The study does not pose risks to participants, with the main inconvenience being tooth enamel darkening, which can be easily resolved with professional dental cleaning. The primary objective is to evaluate the additional clinical effect of both formulations after professional plaque removal over six months in patients undergoing supportive periodontal therapy. The secondary objective is to assess the impact of these antimicrobials on systemic blood pressure.
Interventions
DEVICEMouthwash containing 0.12% CHX (Chlorhexidine)
Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.2% CHX mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).
DEVICEMouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride)
Following the execution of a full mouth periodontal chart, the delivery of oral hygiene instructions and motivation and a session of full mouth ultrasonic debridement, patients, according to the allocation group, will receive a 0.05% CHX + 0.05% CPC mouthwash. Patients will be instructed to use the delivered mouthwashes twice a day (15 ml for 30 seconds).
Sponsors
University of Siena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of sites with Bleeding on Probing | Bleeding on Probing (BOP) will be recorded by a calibrated and blinded examiner at the baseline visit and at one, two, three, and six months after treatment. | Evaluate the additional effect on bleeding on probing of one month application of 0.12% CHX or 0.05% CHX + 0.05% CPC following a professional mechanical plaque removal (PMPR) session for a clinical evaluation period of 6 months in patients undergoing supportive periodontal therapy (gingivitis with reduced periodontium). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral microbiota changes | The subgingival samples will be collected at the baseline visit, at 1, 2, and 3 months | The DNA from subgingival samples will be used to sequence the V3-V4 region of the 16S rRNA gene and will be analyzed using PCR (Polymerase Chain Reaction). The amplicons will be purified and sequenced. |
| Blood Pressure | The systemic systolic and diastolic blood pressure will be measured at baseline, 1 month, 2 months, 3 months and 6 months. | The systemic systolic and diastolic blood pressure (mmHg) will be measured in duplicate at each follow-up visit. |
Countries
Italy
Outcome results
None listed