CompletedEarly Phase 1

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

Brazil105 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range16 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device

Timeframe: baseline, 15 days, 30 days respectively

Trial details

NCT IDNCT02427763

SponsorUniversidade Positivo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

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