Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
研究概览
简要总结
Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly invisible, removable aligners. However, every device used in the mouth can change the buccal flora and increase the number of bacterias. This is a risk factor for enamel demineralization. The treatment can vary in time of use per day. The patient under orthodontic treatment has to use the device for 22 hour each day. When the period of retention comes, it is reduced to 8 hours. The investigators want to know if the concentration of bacterias in saliva and dental plaque will increase, and if the material can cause damage on gingiva.
详细描述
The orthodontic thermoplastic devices became more affordable and with simple techniques, due to the technological advancement. The main advantage of this appliance is that it is nearly invisible, seen that patients do not want to show braces. Others reasons for searching this kind of treatment is because it is removable. While eating, brushing the teeth or even in a important social event, there is the facility to remove the appliance. In the other hand this appliance, according to the american board association, does not finish the treatment as well as the conventional braces. Another problem is that every device placed in the mouth is more plaque retentive, increasing the risk of enamel demineralization. Also, this device disrupts the normal flow of the saliva, preventing the buffering. This study will analyse the amount of streptococcus mutans and lactobacillus in the saliva and in the biofilm of the teeth and of the appliance, seeded in culture medium. Another point, is check the prognosis of the gingival health owing to the contact with the device during the hole treatment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have stabilized their growth between 16 and 40
- •Who have agreed to participate in the study if elected and to sign informed consent
- •Residing in the metropolitan area of Curitiba and have the opportunity to attend recall appointments
排除标准
- •Periodontal status deteriorated
- •missing teeth
- •Cleft lip and palate
- •History of orthognathic surgery
- •History of dental or skeletal open bite
- •Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment
研究组 & 干预措施
Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: hours of use (Essix) (Device)
Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect saliva (Other)
Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect biofilm (Other)
Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect epithelium (Other)
Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: hours of use (Essix) (Device)
Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect saliva (Other)
Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect biofilm (Other)
Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours
Interventions:
- hours of use
- collect biofilm
- collect saliva
- collect epithelium
干预措施: collect epithelium (Other)
结局指标
主要结局
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
时间窗: baseline, 15 days, 30 days respectively
Collect biofilm with a sawb of the thermoplastic device and inoculated at selective plate, to verify the colony-forming unit on the sample
次要结局
- change in the amount of bacterias lactobacillus sp. that adhere to upper teeth(Baseline, 15 days, 30 days, respectively)
- change in the amount of bacterias lactobacillus sp. in the saliva(Baseline, 15 days, 30 days, respectively)
- change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth(Baseline, 15 days, 30 days respectively)
- change in the amount of bacterias streptococcus mutans in the saliva(Baseline, 15 days, 30 days, respectively)
- Check any change in the epithelium(Baseline, 15 days, 30 days, respectively)
研究者
Luiza Cristina do Nascimento
Graduation
Universidade Positivo