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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of sites with Bleeding on Probing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Test 1
Following the completion of a comprehensive periodontal charting, and prior to assigning the patient to one of the two experimental groups, patients will undergo an Oral Hygiene Instruction and Motivation (OHIM) session using a manual toothbrush, individualized interdental brushes, and a commercially available toothpaste containing sodium fluoride. Subsequently, a professional mechanical plaque removal (PMPR) will be performed by the operator, consisting of a conventional dental hygiene session.
In treatment Test 1 patients will receive mouthwash containing 0.12% CHX (Chlorhexidine). Each patient will be instructed to use the assigned mouthwash twice a day (15 ml for 30 s) after common practices of home oral hygiene. Follow-up visits will occur at 1, 2, 3, and 6 months, during which participants will be clinically examined. Microbiological samples will be collected at 1, 2, and 3 months.
干预措施: Mouthwash containing 0.12% CHX (Chlorhexidine) (Device)
Treatment Test 2
After completing a thorough periodontal charting and before allocating patients to one of the two experimental groups, they will receive an Oral Hygiene Instruction and Motivation (OHIM) session using a manual toothbrush, personalized interdental brushes, and a commercially available toothpaste containing sodium fluoride. Following this, an operator will conduct a professional mechanical plaque removal (PMPR), which entails a standard dental hygiene procedure.
In Treatment Test 2 patients will receive mouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride) as the main active ingredients in a patented formulation with optimized bioavailability and they will be instructed to use it twice daily (15 ml for 30 s) following their regular home oral hygiene routine.
Follow-up appointments will be scheduled at 1, 2, 3, and 6 months for clinical examinations of participants, with microbiological samples being collected at 1, 2, and 3 months.
干预措施: Mouthwash containing 0.05% CHX (Chlorhexidine) and 0.05% CPC (Cetylpyridinium Chloride) (Device)
结局指标
主要结局
Number of sites with Bleeding on Probing
时间窗: 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).
次要结局
- Oral microbiota changes(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 will be measured at baseline, 1 month, 2 months, 3 months and 6 months.)
研究者
Nicola Discepoli
Professor
University of Siena