Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of the organoleptic testing scores
研究概览
简要总结
The ODOR trial will be a single-centric, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. The short-term effect of the mouthwashes will be investigated in a 3-hour-long period. The primary endpoint will be the changes in the organoleptic testing scores.
详细描述
Eligible patients will be randomly allocated to two groups in a 1:1 ratio. Necessary data will be collected with prespecified electronic case report forms (REDCap). The statistician will calculate the sample size at the end of the pilot investigation of the first 30-30 patients. If feasible, investigators will continue the study by enrolling more patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Organoleptic test score (OLS)>=2 for IOH
- •Patients with at least 20 teeth
- •8 hours of scented oral hygiene product usage, 4 hours of eating, and 2 hours of drinking restriction
- •on the day of investigation, restriction of alcohol, caffeine, perfume usage, and food intake with characteristic smell
排除标准
- •Medical history of systematic and infectious diseases (e.g., hepatitis, HIV, tuberculosis).
- •Antibiotic use within the month before the study's start or during the trial or any regular medication
- •Extraoral halitosis (will be distinguished by observing the nasal breath)
- •Eat foods (like garlic) linked to oral malodor on the day before and the sampling day, as well as wear heavily fragrant cosmetics on that day.
- •Patients with removable dentures
- •Smokers (Cigars, Cigarettes, Pipes, Chewing tobacco, e-cigarette, or vaping products used in the last month)
结局指标
主要结局
Changes of the organoleptic testing scores
时间窗: immediately after the rinse and 3 hours later
(gold standard 6-point (0-5) intensity scale. The examiner rates it 0 when the patient has no halitosis, and 5 when it is very severe)
次要结局
- Self-perceived halitosis(immediately after the rinse and 3 hours later)
- Changes of the volatile sulfur compounds(immediately after the rinse and 3 hours later)
研究者
Eszter Á Szalai, DMD
Assistant lecturer
Semmelweis University