The Effect of Cotinus Coggygria Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hydrogen Sulfide (H2S) Levels
研究概览
简要总结
The aim of this trial was to investigate the effect of Cotinus Coggygria mouthwash on halitosis using as proxy the levels of the Volatile Sulfur Compounds (VSCs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All patients will be allocated at a 1:1 ratio between group A (Cotinus Coggygria group) and group B (placebo group), for each sex separately using stratified randomization. Two random sequences of 15 letters (A or B) will be obtained from www.random.org (List Randomizer service), one for males and one for females. Those letters were written on paper and then sealed in opaque envelopes, sequentially numbered from M1 to M15 for males and from F1 to F15 for females respectively. All envelopes were sealed, numbered and stored in a drawer by a person not involved in the study. Every patient enrolled in the study will receive an envelope in a numerical order and their name was written on the envelope. Informed consent will be obtained from parents / legal guardians and written consent upon information and prior to the randomization or application of any procedure obtained from the patients.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for the trial must comply with all of the following at randomization:
- •Age between 13 and 18 years for the group with conventional orthodontic appliances.
- •This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.
- •Good general health.
- •Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
- •Total initial VSCs levels above the baseline level of 150ppb.
排除标准
- •Patients will be excluded for any of the following reasons:
- •Active caries
- •Periodontitis
- •Dental fluorosis / dysplasia of the teeth
- •Syndromes, mental disabilities and craniofacial deformities
- •Smoking or use of other tobacco products
- •Allergy to Cotinus Coggygria (Smoke tree)
- •Antibiotics during the last 2 months
- •Chlorhexidine or other mouthwash use in the previous 3 weeks
- •Participation in other trials
结局指标
主要结局
Hydrogen Sulfide (H2S) Levels
时间窗: baseline
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
Hydrogen Sulfide (H2S) Levels
时间窗: 2 weeks
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
次要结局
- Modified plaque index (PI-M)(baseline)
- Gingival Index (GI)(baseline)
- Dimethyl Sulfide [ (CH3)2S] Levels(baseline)
- Methyl-mercaptan (CH3SH) Levels(baseline)
- Gingival Index (GI)(2 weeks)
- Modified plaque index (PI-M)(2 weeks)
- Dimethyl Sulfide [ (CH3)2S] Levels(2 weeks)
- Methyl-mercaptan (CH3SH) Levels(2 weeks)
研究者
Iosif Sifakakis
Associate Professor
University of Athens