The Effect of Chios' Mastic Toothpaste on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Modified plaque index (PI-M)
研究概览
简要总结
The aim of this trial was to investigate the effect of mastic toothpaste 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
- Double (Participant, Investigator)
盲法说明
All patients will be allocated at a 1:1 ratio between group A (mastic 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 mastic
- •Antibiotics during the last 2 months
- •Chlorhexidine in the previous 3 weeks
- •Participation in other trials
结局指标
主要结局
Modified plaque index (PI-M)
时间窗: 2 weeks
The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
次要结局
未报告次要终点
研究者
Iosif Sifakakis
Associate Professor
University of Athens