A Randomized Double-Blind Crossover Clinical Trial Evaluating the Efficacy of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide in Patients With Oral Malodor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Hydrogen sulfide (H₂S) concentration in breath
研究概览
简要总结
Halitosis significantly impacts the quality of a patient's life. This randomized, double-blind crossover trial evaluates a mouthwash containing chlorhexidine (0.01%) and chlorine dioxide (0.05%) compared with placebo. Forty participants rinsed twice daily for 2 weeks, followed by a 2-week washout and crossover. The primary outcomes were volatile sulfur compounds (H₂S, CH₃SH), measured by OralChroma. Secondary outcomes included plaque index, gingival index, bleeding on probing, tongue coating, and salivary bacterial counts (Aa, Pg, Fn, Pi, and Ec).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both mouthwashes were packaged in identical opaque bottles labeled only with numerical codes (1 or 2) by an independent technician who was not involved in data collection or analysis. The two formulations were identical in appearance, color, odor, and taste to maintain blinding. The allocation code was kept confidential and sealed in an envelope until all data had been collected and statistical analyses were completed.
Participants, clinicians, and outcome assessors were blinded to group allocation throughout the trial. Unblinding occurred only after all data analyses were completed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥20 natural teeth
- •H₂S >1.5 ng/10ml or CH₃SH >0.5 ng/10ml
- •Signed informed consent
排除标准
- •Systemic disease
- •Pregnancy or lactation
- •Periodontal pockets ≥4 mm
- •Recent antibiotic use (<1 month)
- •Orthodontic appliances or dentures
- •Allergy to CHX or C
研究组 & 干预措施
CHX-CDO Mouthwash
Participants rinsed with a test mouthwash containing 0.01% chlorhexidine and 0.05% chlorine dioxide. Each participant used 15 mL of the solution twice daily (morning and evening) for 30 seconds over a period of 2 weeks. The mouthwash bottles were identical in appearance to maintain blinding.
干预措施: CHX 0.01% + CDO 0.05% mouthwash (Other)
Placebo Mouthwash
Participants rinsed with a placebo mouthwash containing the same excipients, color, and flavoring agents but without chlorhexidine or chlorine dioxide. Each participant used 15 mL of the placebo solution twice daily for 30 seconds over 2 weeks.
干预措施: Placebo mouthwash (Other)
结局指标
主要结局
Change in Hydrogen sulfide (H₂S) concentration in breath
时间窗: baseline, immediate post-rinse, 2 weeks
The concentration of hydrogen sulfide (H₂S) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to assess the efficacy of the mouthwash in reducing volatile sulfur compounds.
Change in Methyl mercaptan (CH₃SH) concentration in breath
时间窗: Baseline, immediate post-rinse, 2 weeks
The concentration of methyl mercaptan (CH₃SH) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to evaluate the short-term and sustained effects of the mouthwash on halitosis.
次要结局
- Change of plaque index(At baseline and 2 weeks of mouthwash use)
- Change in Gingival Index (GI)(At baseline and 2 weeks of mouthwash use)
- Change in Bleeding on Probing (BOP)(At baseline and 2 weeks of mouthwash use)
- Change in Tongue Coating Index(At baseline and 2 weeks of mouthwash use)
- Change in salivary bacterial load (qPCR quantification)(At baseline and 2 weeks of mouthwash use)