Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in ΔE before and after the use of chlorhexidine
研究概览
简要总结
The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The efficacy of the products and the patient's opinion and acceptance were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health conditions without a medical history of medication that might interfere with periodontal tissues
- •Good plaque control (FMPS ≤ 25%) and low levels of infection (FMBS ≤ 25%)
- •Need for periodontal surgery
排除标准
- •Allergy to CHX
- •Lack of written informed consent
研究组 & 干预措施
Chlorhexidine 0,2%
After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX.
干预措施: Chlorhexidine (Drug)
Chlorhexidine 0,2% with ADS
After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX with ADS.
干预措施: Chlorhexidine (Drug)
Chlorhexidine 0,12%
After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.12% CHX.
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Change in ΔE before and after the use of chlorhexidine
时间窗: Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks
Change in ΔE before and after the use of chlorhexidine (ΔE is a measurement used to indicate how much a color deviates from an accepted standard. Perfect color has a ΔE of zero.)
次要结局
未报告次要终点
研究者
dott. Lorenzo Bevilacqua
DDS, MS
University of Trieste