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NCT Number: NCT02427763

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

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.

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Key information

Conditions

Malocclusion Orthodontic Appliance Complication Stomatognathic Diseases Tooth Diseases

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Universidade Positivo

Curitiba, Paraná, 81280-330, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hours of use (Essix)

Device

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

Other names: retainer use, aligner use

collect saliva

Other

the patient spit during 30 seconds in a small bottle

Other names: saliva

collect biofilm

Other

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

Other names: biofilm

collect epithelium

Other

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

Other names: epithelium

Primary outcomes

  1. 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

  1. change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth

    Time frame: Baseline, 15 days, 30 days respectively

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

  2. change in the amount of bacterias lactobacillus sp. that adhere to upper teeth

    Time frame: Baseline, 15 days, 30 days, respectively

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

  3. change in the amount of bacterias streptococcus mutans in the saliva

    Time frame: Baseline, 15 days, 30 days, respectively

    Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample

  4. change in the amount of bacterias lactobacillus sp. in the saliva

    Time frame: Baseline, 15 days, 30 days, respectively

    Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample

  5. Check any change in the epithelium

    Time frame: Baseline, 15 days, 30 days, respectively

    Use cytobrush to collect gingiva

Sponsors and collaborators

Lead sponsor

Universidade Positivo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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