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

Primary Purpose

Malocclusion, Orthodontic Appliance Complication

Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
hours of use (Essix)
collect saliva
collect biofilm
collect epithelium
Sponsored by
Universidade Positivo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malocclusion focused on measuring Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus, Epithelium

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Positivo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Retainer use

Aligner use

Arm Description

The volunteer use a thermoplastic appliance (Essix) for 8hours Interventions: hours of use collect biofilm collect saliva collect epithelium

The volunteer use thermoplastic appliance (Essix) for 22 hours Interventions: hours of use collect biofilm collect saliva collect epithelium

Outcomes

Primary Outcome Measures

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

change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
change in the amount of bacterias lactobacillus sp. that adhere to upper teeth
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
change in the amount of bacterias streptococcus mutans in the saliva
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
change in the amount of bacterias lactobacillus sp. in the saliva
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
Check any change in the epithelium
Use cytobrush to collect gingiva

Full Information

First Posted
February 24, 2015
Last Updated
April 22, 2015
Sponsor
Universidade Positivo
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1. Study Identification

Unique Protocol Identification Number
NCT02427763
Brief Title
Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
Official Title
Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Positivo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Orthodontic Appliance Complication
Keywords
Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus, Epithelium

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retainer use
Arm Type
Active Comparator
Arm Description
The volunteer use a thermoplastic appliance (Essix) for 8hours Interventions: hours of use collect biofilm collect saliva collect epithelium
Arm Title
Aligner use
Arm Type
Active Comparator
Arm Description
The volunteer use thermoplastic appliance (Essix) for 22 hours Interventions: hours of use collect biofilm collect saliva collect epithelium
Intervention Type
Device
Intervention Name(s)
hours of use (Essix)
Other Intervention Name(s)
retainer use, aligner use
Intervention Description
the patient will use de thermoplastic device during the night or during all day
Intervention Type
Other
Intervention Name(s)
collect saliva
Other Intervention Name(s)
saliva
Intervention Description
the patient spit during 30 seconds in a small bottle
Intervention Type
Other
Intervention Name(s)
collect biofilm
Other Intervention Name(s)
biofilm
Intervention Description
a sterile swab is rubbed at the buccal surface of the upper teeth
Intervention Type
Other
Intervention Name(s)
collect epithelium
Other Intervention Name(s)
epithelium
Intervention Description
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Primary Outcome Measure Information:
Title
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
Description
Collect biofilm with a sawb of the thermoplastic device and inoculated at selective plate, to verify the colony-forming unit on the sample
Time Frame
baseline, 15 days, 30 days respectively
Secondary Outcome Measure Information:
Title
change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
Description
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
Time Frame
Baseline, 15 days, 30 days respectively
Title
change in the amount of bacterias lactobacillus sp. that adhere to upper teeth
Description
Collect biofilm with a sawb of the upper teeth and inoculated at selective plate, to verify the colony-forming unit on the sample
Time Frame
Baseline, 15 days, 30 days, respectively
Title
change in the amount of bacterias streptococcus mutans in the saliva
Description
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
Time Frame
Baseline, 15 days, 30 days, respectively
Title
change in the amount of bacterias lactobacillus sp. in the saliva
Description
Collect saliva and inoculated at selective plate, to verify the colony-forming unit on the sample
Time Frame
Baseline, 15 days, 30 days, respectively
Title
Check any change in the epithelium
Description
Use cytobrush to collect gingiva
Time Frame
Baseline, 15 days, 30 days, respectively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flares Baratto Filho, PhD
Organizational Affiliation
Universidade Positivo
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Positivo
City
Curitiba
State/Province
PR
ZIP/Postal Code
81280-330
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19726491
Citation
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Results Reference
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PubMed Identifier
23540639
Citation
do Nascimento LE, Pithon MM, dos Santos RL, Freitas AO, Alviano DS, Nojima LI, Nojima MC, Ruellas AC. Colonization of Streptococcus mutans on esthetic brackets: self-ligating vs conventional. Am J Orthod Dentofacial Orthop. 2013 Apr;143(4 Suppl):S72-7. doi: 10.1016/j.ajodo.2012.07.017.
Results Reference
background
PubMed Identifier
21508267
Citation
Jaderberg S, Feldmann I, Engstrom C. Removable thermoplastic appliances as orthodontic retainers--a prospective study of different wear regimens. Eur J Orthod. 2012 Aug;34(4):475-9. doi: 10.1093/ejo/cjr040. Epub 2011 Apr 20.
Results Reference
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PubMed Identifier
21187528
Citation
Low B, Lee W, Seneviratne CJ, Samaranayake LP, Hagg U. Ultrastructure and morphology of biofilms on thermoplastic orthodontic appliances in 'fast' and 'slow' plaque formers. Eur J Orthod. 2011 Oct;33(5):577-83. doi: 10.1093/ejo/cjq126. Epub 2010 Dec 27.
Results Reference
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PubMed Identifier
24880842
Citation
Mai W, He J, Meng H, Jiang Y, Huang C, Li M, Yuan K, Kang N. Comparison of vacuum-formed and Hawley retainers: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Jun;145(6):720-7. doi: 10.1016/j.ajodo.2014.01.019.
Results Reference
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PubMed Identifier
19828592
Citation
Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14.
Results Reference
background
PubMed Identifier
18407023
Citation
Ziuchkovski JP, Fields HW, Johnston WM, Lindsey DT. Assessment of perceived orthodontic appliance attractiveness. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4 Suppl):S68-78. doi: 10.1016/j.ajodo.2006.07.025.
Results Reference
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PubMed Identifier
22554754
Citation
Turkoz C, Canigur Bavbek N, Kale Varlik S, Akca G. Influence of thermoplastic retainers on Streptococcus mutans and Lactobacillus adhesion. Am J Orthod Dentofacial Orthop. 2012 May;141(5):598-603. doi: 10.1016/j.ajodo.2011.11.021.
Results Reference
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Citation
Turkkahraman H, Sayin MO, Bozkurt FY, Yetkin Z, Kaya S, Onal S. Archwire ligation techniques, microbial colonization, and periodontal status in orthodontically treated patients. Angle Orthod. 2005 Mar;75(2):231-6. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
Results Reference
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Citation
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Results Reference
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Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device

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