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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427763
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Luiza Cristina do Nascimento, Universidade Positivo

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.

Condition or disease Intervention/treatment Phase
Malocclusion Orthodontic Appliance Complication Device: hours of use (Essix) Other: collect saliva Other: collect biofilm Other: collect epithelium Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Active Comparator: Retainer use

The volunteer use a thermoplastic appliance (Essix) for 8hours

Interventions:

  • hours of use
  • collect biofilm
  • collect saliva
  • collect epithelium
Device: hours of use (Essix)
the patient will use de thermoplastic device during the night or during all day
Other Names:
  • retainer use
  • aligner use

Other: collect saliva
the patient spit during 30 seconds in a small bottle
Other Name: saliva

Other: collect biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
Other Name: biofilm

Other: collect epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Other Name: epithelium

Active Comparator: Aligner use

The volunteer use thermoplastic appliance (Essix) for 22 hours

Interventions:

  • hours of use
  • collect biofilm
  • collect saliva
  • collect epithelium
Device: hours of use (Essix)
the patient will use de thermoplastic device during the night or during all day
Other Names:
  • retainer use
  • aligner use

Other: collect saliva
the patient spit during 30 seconds in a small bottle
Other Name: saliva

Other: collect biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
Other Name: biofilm

Other: collect epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Other Name: epithelium




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427763


Locations
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Brazil
Universidade Positivo
Curitiba, PR, Brazil, 81280-330
Sponsors and Collaborators
Universidade Positivo
Investigators
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Study Chair: Flares Baratto Filho, PhD Universidade Positivo
Publications:

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Responsible Party: Luiza Cristina do Nascimento, Graduation, Universidade Positivo
ClinicalTrials.gov Identifier: NCT02427763    
Other Study ID Numbers: luiza2014
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Luiza Cristina do Nascimento, Universidade Positivo:
Removable Orthodontic Appliance;
malocclusion
Streptococcus mutans
Lactobacillus
Epithelium
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases