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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427763
• Other study ID #: luiza2014
• Status: Completed
• Phase: Phase 0
• First received: February 24, 2015
• Last updated: April 22, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Universidade Positivo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malocclusion
• Orthodontic Appliance Complication

Intervention

Device:
• hours of use (Essix)
the patient will use de thermoplastic device during the night or during all day

Other:
• collect saliva
the patient spit during 30 seconds in a small bottle
• collect biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
• collect epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch

Locations

Country	Name	City	State
Brazil	Universidade Positivo	Curitiba	PR

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Positivo

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Dinçer 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. — View 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. — View Citation

Jäderberg S, Feldmann I, Engström 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. — View Citation

Low B, Lee W, Seneviratne CJ, Samaranayake LP, Hägg 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. — View 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. Review. — View Citation

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. — View 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. — View Citation

Türkkahraman 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. — View Citation

Türköz C, Canigür Bavbek N, Kale Varlik S, Akça 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Baseline, 15 days, 30 days respectively	Yes
Secondary	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	Baseline, 15 days, 30 days, respectively	Yes
Secondary	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	Baseline, 15 days, 30 days, respectively	Yes
Secondary	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	Baseline, 15 days, 30 days, respectively	Yes
Secondary	Check any change in the epithelium	Use cytobrush to collect gingiva	Baseline, 15 days, 30 days, respectively	Yes