Skip to main content
Clinical Trials/NCT02427763
NCT02427763
Completed
Early Phase 1

Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner

Universidade Positivo1 site in 1 country105 target enrollmentOctober 2014

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Malocclusion
Sponsor
Universidade Positivo
Enrollment
105
Locations
1
Primary Endpoint
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luiza Cristina do Nascimento

Graduation

Universidade Positivo

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

Outcomes

Primary Outcomes

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

Time Frame: baseline, 15 days, 30 days respectively

Collect biofilm with a sawb of the thermoplastic device and inoculated at selective plate, to verify the colony-forming unit on the sample

Secondary Outcomes

  • change in the amount of bacterias lactobacillus sp. that adhere to upper teeth(Baseline, 15 days, 30 days, respectively)
  • change in the amount of bacterias lactobacillus sp. in the saliva(Baseline, 15 days, 30 days, respectively)
  • change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth(Baseline, 15 days, 30 days respectively)
  • change in the amount of bacterias streptococcus mutans in the saliva(Baseline, 15 days, 30 days, respectively)
  • Check any change in the epithelium(Baseline, 15 days, 30 days, respectively)

Study Sites (1)

Loading locations...

Similar Trials