NCT02427763

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Universidade Positivo · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Malocclusion
• Orthodontic Appliance Complication

Interventions

Type	Name	Description
DEVICE	hours of use (Essix)	the patient will use de thermoplastic device during the night or during all day
OTHER	collect saliva	the patient spit during 30 seconds in a small bottle
OTHER	collect biofilm	a sterile swab is rubbed at the buccal surface of the upper teeth
OTHER	collect epithelium	a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2015-04-28
• Last updated: 2015-04-28

Locations

1 site across 1 country: Brazil