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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
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).
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).
AOUS
Siena, Italy
Number of sites with Bleeding on Probing
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).
Time frame: 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.
Oral microbiota changes
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.
Time frame: The subgingival samples will be collected at the baseline visit, at 1, 2, and 3 months
Blood Pressure
The systemic systolic and diastolic blood pressure (mmHg) will be measured in duplicate at each follow-up visit.
Time frame: The systemic systolic and diastolic blood pressure will be measured at baseline, 1 month, 2 months, 3 months and 6 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.