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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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427763
Enrollment
105
Registered
2015-04-28
Start date
2014-10-31
Completion date
2015-03-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Orthodontic Appliance Complication

Keywords

Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus, Epithelium

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.

Interventions

DEVICEhours of use (Essix)

the patient will use de thermoplastic device during the night or during all day

OTHERcollect saliva

the patient spit during 30 seconds in a small bottle

OTHERcollect biofilm

a sterile swab is rubbed at the buccal surface of the upper teeth

OTHERcollect epithelium

a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch

Sponsors

Universidade Positivo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic devicebaseline, 15 days, 30 days respectivelyCollect biofilm with a sawb of the thermoplastic device and inoculated at selective plate, to verify the colony-forming unit on the sample

Secondary

MeasureTime frameDescription
change in the amount of bacterias streptococcus mutans in the salivaBaseline, 15 days, 30 days, respectivelyCollect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
change in the amount of bacterias lactobacillus sp. in the salivaBaseline, 15 days, 30 days, respectivelyCollect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
Check any change in the epitheliumBaseline, 15 days, 30 days, respectivelyUse cytobrush to collect gingiva
change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teethBaseline, 15 days, 30 days respectivelyCollect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
change in the amount of bacterias lactobacillus sp. that adhere to upper teethBaseline, 15 days, 30 days, respectivelyCollect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026