Clinical trial NCT02427763: Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
Official title: Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Malocclusion
Orthodontic Appliance Complication
Keywords: Removable Orthodontic Appliance;
malocclusion
Streptococcus mutans
Lactobacillus
Epithelium
Lead sponsor: Universidade Positivo
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
timeFrame: baseline, 15 days, 30 days respectively
Secondary outcomes:
measure: change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
timeFrame: Baseline, 15 days, 30 days respectively
measure: change in the amount of bacterias lactobacillus sp. that adhere to upper teeth
timeFrame: Baseline, 15 days, 30 days, respectively
measure: change in the amount of bacterias streptococcus mutans in the saliva
timeFrame: Baseline, 15 days, 30 days, respectively
measure: change in the amount of bacterias lactobacillus sp. in the saliva
timeFrame: Baseline, 15 days, 30 days, respectively
measure: Check any change in the epithelium
timeFrame: Baseline, 15 days, 30 days, respectively
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Universidade Positivo
state: PR
Study officials:
affiliation: Universidade Positivo
name: Flares Baratto Filho, PhD
role: STUDY_CHAIR
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