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

NCT ID: NCT02427763

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Malocclusion Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Retainer use

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

Interventions:

* hours of use
* collect biofilm
* collect saliva
* collect epithelium

Group Type ACTIVE_COMPARATOR

hours of use (Essix)

Intervention Type DEVICE

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

collect saliva

Intervention Type OTHER

the patient spit during 30 seconds in a small bottle

collect biofilm

Intervention Type OTHER

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

collect epithelium

Intervention Type OTHER

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

Aligner use

The volunteer use thermoplastic appliance (Essix) for 22 hours

Interventions:

* hours of use
* collect biofilm
* collect saliva
* collect epithelium

Group Type ACTIVE_COMPARATOR

hours of use (Essix)

Intervention Type DEVICE

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

collect saliva

Intervention Type OTHER

the patient spit during 30 seconds in a small bottle

collect biofilm

Intervention Type OTHER

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

collect epithelium

Intervention Type OTHER

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

Interventions

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hours of use (Essix)

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

Intervention Type DEVICE

collect saliva

the patient spit during 30 seconds in a small bottle

Intervention Type OTHER

collect biofilm

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

Intervention Type OTHER

collect epithelium

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

Intervention Type OTHER

Other Intervention Names

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retainer use aligner use saliva biofilm epithelium

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Positivo

OTHER

Sponsor Role lead

Responsible Party

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Luiza Cristina do Nascimento

Graduation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Flares Baratto Filho, PhD

Role: STUDY_CHAIR

Universidade Positivo

Locations

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Universidade Positivo

Curitiba, ParanĂ¡, Brazil

Site Status

Countries

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Brazil

References

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Dincer M, Isik Aslan B. Effects of thermoplastic retainers on occlusal contacts. Eur J Orthod. 2010 Feb;32(1):6-10. doi: 10.1093/ejo/cjp062. Epub 2009 Sep 2.

Reference Type BACKGROUND
PMID: 19726491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23540639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21508267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21187528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24880842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19828592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18407023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22554754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15825788 (View on PubMed)

Shpack N, Greenstein RB, Gazit D, Sarig R, Vardimon AD. Efficacy of three hygienic protocols in reducing biofilm adherence to removable thermoplastic appliance. Angle Orthod. 2014 Jan;84(1):161-70. doi: 10.2319/012413-75.1. Epub 2013 Jun 20.

Reference Type BACKGROUND
PMID: 23786595 (View on PubMed)

Other Identifiers

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luiza2014

Identifier Type: -

Identifier Source: org_study_id

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