Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner

Conditions
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Malocclusion, Orthodontic Appliance Complication

Intervention / Treatment
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* Device: hours of use (Essix)
* Other: collect saliva
* Other: collect biofilm
* Other: collect epithelium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retainer use<br>The volunteer use a thermoplastic appliance (Essix) for 8hours Interventions: hours of use collect biofilm collect saliva collect epithelium | Device: hours of use (Essix)<br>* the patient will use de thermoplastic device during the night or during all day<br>* Other names: aligner use;Other: collect saliva<br>* the patient spit during 30 seconds in a small bottle<br>* Other names: saliva;Other: collect biofilm<br>* a sterile swab is rubbed at the buccal surface of the upper teeth<br>* Other names: biofilm;Other: collect epithelium<br>* a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch<br>* Other names: epithelium;|
| Active Comparator: Aligner use<br>The volunteer use thermoplastic appliance (Essix) for 22 hours Interventions: hours of use collect biofilm collect saliva collect epithelium | Device: hours of use (Essix)<br>* the patient will use de thermoplastic device during the night or during all day<br>* Other names: aligner use;Other: collect saliva<br>* the patient spit during 30 seconds in a small bottle<br>* Other names: saliva;Other: collect biofilm<br>* a sterile swab is rubbed at the buccal surface of the upper teeth<br>* Other names: biofilm;Other: collect epithelium<br>* a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch<br>* Other names: epithelium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth | 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 | 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 | 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 | 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 | Use cytobrush to collect gingiva | Baseline, 15 days, 30 days, respectively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelium, Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus