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

NCT02427763 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-04-28

No results posted yet for this study

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.

Conditions

  • Malocclusion
  • Orthodontic Appliance Complication

Interventions

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

Sponsors & Collaborators

  • Universidade Positivo

    lead OTHER

Principal Investigators

  • Flares Baratto Filho, PhD · Universidade Positivo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427763 on ClinicalTrials.gov