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

April 22, 2015 updated by: Luiza Cristina do Nascimento, Universidade Positivo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PR
      • Curitiba, PR, Brazil, 81280-330
        • Universidade Positivo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • saliva
Other: collect biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
Other Names:
  • biofilm
Other: collect epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Other Names:
  • 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 Names:
  • saliva
Other: collect biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
Other Names:
  • biofilm
Other: collect epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Other Names:
  • epithelium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 15 days, 30 days respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 15 days, 30 days respectively
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
Baseline, 15 days, 30 days, respectively
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
Baseline, 15 days, 30 days, respectively
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
Baseline, 15 days, 30 days, respectively
Check any change in the epithelium
Time Frame: Baseline, 15 days, 30 days, respectively
Use cytobrush to collect gingiva
Baseline, 15 days, 30 days, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Positivo

Investigators

  • Study Chair: Flares Baratto Filho, PhD, Universidade Positivo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • luiza2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malocclusion

Clinical Trials on hours of use (Essix)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe