Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
2015年4月22日 更新者：Luiza Cristina do Nascimento、Universidade Positivo
Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
105
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
PR
-
Curitiba、PR、巴西、81280-330
- Universidade Positivo
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 40年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours Interventions:
|
the patient will use de thermoplastic device during the night or during all day
其他名称：
the patient spit during 30 seconds in a small bottle
其他名称：
a sterile swab is rubbed at the buccal surface of the upper teeth
其他名称：
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
其他名称：
|
|
有源比较器：Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours Interventions:
|
the patient will use de thermoplastic device during the night or during all day
其他名称：
the patient spit during 30 seconds in a small bottle
其他名称：
a sterile swab is rubbed at the buccal surface of the upper teeth
其他名称：
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
大体时间：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
|
baseline, 15 days, 30 days respectively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
大体时间：Baseline, 15 days, 30 days respectively
|
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
|
Baseline, 15 days, 30 days respectively
|
|
change in the amount of bacterias lactobacillus sp. that adhere to upper teeth
大体时间：Baseline, 15 days, 30 days, respectively
|
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
|
Baseline, 15 days, 30 days, respectively
|
|
change in the amount of bacterias streptococcus mutans in the saliva
大体时间：Baseline, 15 days, 30 days, respectively
|
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
|
Baseline, 15 days, 30 days, respectively
|
|
change in the amount of bacterias lactobacillus sp. in the saliva
大体时间：Baseline, 15 days, 30 days, respectively
|
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
|
Baseline, 15 days, 30 days, respectively
|
|
Check any change in the epithelium
大体时间：Baseline, 15 days, 30 days, respectively
|
Use cytobrush to collect gingiva
|
Baseline, 15 days, 30 days, respectively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Flares Baratto Filho, PhD、Universidade Positivo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dincer M, Isik Aslan B. Effects of thermoplastic retainers on occlusal contacts. Eur J Orthod. 2010 Feb;32(1):6-10. doi: 10.1093/ejo/cjp062. Epub 2009 Sep 2.
- do Nascimento LE, Pithon MM, dos Santos RL, Freitas AO, Alviano DS, Nojima LI, Nojima MC, Ruellas AC. Colonization of Streptococcus mutans on esthetic brackets: self-ligating vs conventional. Am J Orthod Dentofacial Orthop. 2013 Apr;143(4 Suppl):S72-7. doi: 10.1016/j.ajodo.2012.07.017.
- Jaderberg S, Feldmann I, Engstrom C. Removable thermoplastic appliances as orthodontic retainers--a prospective study of different wear regimens. Eur J Orthod. 2012 Aug;34(4):475-9. doi: 10.1093/ejo/cjr040. Epub 2011 Apr 20.
- Low B, Lee W, Seneviratne CJ, Samaranayake LP, Hagg U. Ultrastructure and morphology of biofilms on thermoplastic orthodontic appliances in 'fast' and 'slow' plaque formers. Eur J Orthod. 2011 Oct;33(5):577-83. doi: 10.1093/ejo/cjq126. Epub 2010 Dec 27.
- Mai W, He J, Meng H, Jiang Y, Huang C, Li M, Yuan K, Kang N. Comparison of vacuum-formed and Hawley retainers: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Jun;145(6):720-7. doi: 10.1016/j.ajodo.2014.01.019.
- Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14.
- Ziuchkovski JP, Fields HW, Johnston WM, Lindsey DT. Assessment of perceived orthodontic appliance attractiveness. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4 Suppl):S68-78. doi: 10.1016/j.ajodo.2006.07.025.
- Turkoz C, Canigur Bavbek N, Kale Varlik S, Akca G. Influence of thermoplastic retainers on Streptococcus mutans and Lactobacillus adhesion. Am J Orthod Dentofacial Orthop. 2012 May;141(5):598-603. doi: 10.1016/j.ajodo.2011.11.021.
- Turkkahraman H, Sayin MO, Bozkurt FY, Yetkin Z, Kaya S, Onal S. Archwire ligation techniques, microbial colonization, and periodontal status in orthodontically treated patients. Angle Orthod. 2005 Mar;75(2):231-6. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
- Shpack N, Greenstein RB, Gazit D, Sarig R, Vardimon AD. Efficacy of three hygienic protocols in reducing biofilm adherence to removable thermoplastic appliance. Angle Orthod. 2014 Jan;84(1):161-70. doi: 10.2319/012413-75.1. Epub 2013 Jun 20.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年10月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2015年2月24日
首先提交符合 QC 标准的
2015年4月22日
首次发布 (估计)
2015年4月28日
研究记录更新
最后更新发布 (估计)
2015年4月28日
上次提交的符合 QC 标准的更新
2015年4月22日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.