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

NCT02427763 | Completed Early Phase 1 DMC

• 1 other identifier: luiza2014
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Orthodontic Appliance Complication

Keywords

Removable Orthodontic Appliance;; malocclusion; Streptococcus mutans; Lactobacillus; Epithelium

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 15 days, 30 days respectively

Secondary Outcomes (5)

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

  Baseline, 15 days, 30 days respectively

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

  Baseline, 15 days, 30 days, respectively

• change in the amount of bacterias streptococcus mutans in the saliva

  Baseline, 15 days, 30 days, respectively

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

  Baseline, 15 days, 30 days, respectively

• Check any change in the epithelium

  Baseline, 15 days, 30 days, respectively

Study Arms (2)

Retainer use

ACTIVE COMPARATOR

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

Device: hours of use (Essix); Other: collect saliva; Other: collect biofilm; Other: collect epithelium

Aligner use

ACTIVE COMPARATOR

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

Device: hours of use (Essix); Other: collect saliva; Other: collect biofilm; Other: collect epithelium

Interventions

hours of use (Essix) DEVICE

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

Also known as: retainer use, aligner use

Aligner use; Retainer use

collect saliva OTHER

the patient spit during 30 seconds in a small bottle

Also known as: saliva

Aligner use; Retainer use

collect biofilm OTHER

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

Also known as: biofilm

Aligner use; Retainer use

collect epithelium OTHER

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

Also known as: epithelium

Aligner use; Retainer use

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Positivo: lead

Study Sites (1)

Universidade Positivo

Curitiba, Paraná, 81280-330, Brazil

Location

Related Publications (10)

• 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.

  PMID: 19726491 BACKGROUND

• 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.

  PMID: 23540639 BACKGROUND

• 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.

  PMID: 21508267 BACKGROUND

• 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.

  PMID: 21187528 BACKGROUND

• 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.

  PMID: 24880842 BACKGROUND

• 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.

  PMID: 19828592 BACKGROUND

• 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.

  PMID: 18407023 BACKGROUND

• 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.

  PMID: 22554754 BACKGROUND

• 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.

  PMID: 15825788 BACKGROUND

• 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.

  PMID: 23786595 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Biofilms

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Microbiological Phenomena

Study Officials

• Flares Baratto Filho, PhD

  Universidade Positivo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduation

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: April 28, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

BR (1)