At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
In Brief
A Early Phase 1 clinical trial evaluating hours of use (Essix), collect saliva, and 2 other interventions for Malocclusion and Orthodontic Appliance Complication. Completed, enrolled 105 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
the patient will use de thermoplastic device during the night or during all day
the patient spit during 30 seconds in a small bottle
a sterile swab is rubbed at the buccal surface of the upper teeth
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch