Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
22 april 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
105
Fase
- Vroege fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
PR
-
Curitiba, PR, Brazilië, 81280-330
- Universidade Positivo
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar tot 40 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Retainer use
The volunteer use a thermoplastic appliance (Essix) for 8hours Interventions:
|
the patient will use de thermoplastic device during the night or during all day
Andere namen:
the patient spit during 30 seconds in a small bottle
Andere namen:
a sterile swab is rubbed at the buccal surface of the upper teeth
Andere namen:
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Andere namen:
|
|
Actieve vergelijker: Aligner use
The volunteer use thermoplastic appliance (Essix) for 22 hours Interventions:
|
the patient will use de thermoplastic device during the night or during all day
Andere namen:
the patient spit during 30 seconds in a small bottle
Andere namen:
a sterile swab is rubbed at the buccal surface of the upper teeth
Andere namen:
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 15 days, 30 days, respectively
|
Use cytobrush to collect gingiva
|
Baseline, 15 days, 30 days, respectively
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Flares Baratto Filho, PhD, Universidade Positivo
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2014
Primaire voltooiing (Werkelijk)
1 december 2014
Studie voltooiing (Werkelijk)
1 maart 2015
Studieregistratiedata
Eerst ingediend
24 februari 2015
Eerst ingediend dat voldeed aan de QC-criteria
22 april 2015
Eerst geplaatst (Schatting)
28 april 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
28 april 2015
Laatste update ingediend die voldeed aan QC-criteria
22 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- luiza2014
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