MalocclusionEarly Phase 1NCT02427763
Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
A Early Phase 1 study testing hours of use (Essix), collect saliva and collect biofilm in people with Malocclusion and Orthodontic Appliance Complication, run by Universidade Positivo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Orthodontic Appliance Complication
- What is being tested?
- hours of use (Essix), collect saliva and collect biofilm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Mar 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malocclusion, Orthodontic Appliance Complication
- Being tested
- hours of use (Essix), collect saliva, collect biofilm, collect epithelium
- Keywords
- Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus, Epithelium
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hours of use (Essix)Device
Also called retainer use, aligner use
the patient will use de thermoplastic device during the night or during all day
collect salivaOther
Also called saliva
the patient spit during 30 seconds in a small bottle
collect biofilmOther
Also called biofilm
a sterile swab is rubbed at the buccal surface of the upper teeth
collect epitheliumOther
Also called epithelium
a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
| Study group | Role | What they receive |
|---|---|---|
| Retainer use | Active comparator | The volunteer use a thermoplastic appliance (Essix) for 8hours
Interventions:
* hours of use
* collect biofilm
* collect saliva
* collect epithelium Receives: 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 Receives: Device: hours of use (Essix); Other: collect saliva; Other: collect biofilm; Other: collect epithelium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 15 days, 30 days respectively
Secondary outcomes (5)
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
Measured: Baseline, 15 days, 30 days respectively
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
Measured: Baseline, 15 days, 30 days, respectively
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
Measured: Baseline, 15 days, 30 days, respectively
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
Measured: Baseline, 15 days, 30 days, respectively
Check any change in the epithelium
Use cytobrush to collect gingiva
Measured: Baseline, 15 days, 30 days, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Positivo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiza Cristina do Nascimento, Universidade Positivo
- Investigators
- Flares Baratto Filho, PhD, Study chair, Universidade Positivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427763
- Sponsor's protocol ID
- luiza2014
- Status last verified
- Apr 2015
- First submitted
- 24 Feb 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19726491do 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.
PubMed 23540639Jaderberg 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.
PubMed 21508267Low 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.
PubMed 21187528Mai 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.
PubMed 24880842Thickett 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.
PubMed 19828592Ziuchkovski 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.
PubMed 18407023Turkoz 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.
PubMed 22554754Turkkahraman 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.
PubMed 15825788Shpack 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.
PubMed 23786595
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epithelial Changes and Streptococci Mutans and Lactobacilli Quantify Related With the Use of Thermoplastic Aligner
- ClinicalTrials.gov ID
- NCT02427763
- Acronym / sponsor ID
- luiza2014
- Conditions
- Malocclusion, Orthodontic Appliance Complication
- Keywords
- Removable Orthodontic Appliance;, malocclusion, Streptococcus mutans, Lactobacillus, Epithelium
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universidade PositivoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retainer use | Active comparator | Device: hours of use (Essix), Other: collect saliva, Other: collect biofilm, Other: collect epitheliumThe volunteer use a thermoplastic appliance (Essix) for 8hours Interventions: * hours of use * collect biofilm * collect saliva * collect epithelium |
| Aligner use | Active comparator | Device: hours of use (Essix), Other: collect saliva, Other: collect biofilm, Other: collect epitheliumThe volunteer use thermoplastic appliance (Essix) for 22 hours Interventions: * hours of use * collect biofilm * collect saliva * collect epithelium |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Periodontal status deteriorated
- missing teeth
- Cleft lip and palate
- History of orthognathic surgery
- History of dental or skeletal open bite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hours of use (Essix)Also: retainer use, aligner usethe patient will use de thermoplastic device during the night or during all day | Device | Aligner use, Retainer use |
| collect salivaAlso: salivathe patient spit during 30 seconds in a small bottle | Other | Aligner use, Retainer use |
| collect biofilmAlso: biofilma sterile swab is rubbed at the buccal surface of the upper teeth | Other | Aligner use, Retainer use |
| collect epitheliumAlso: epitheliuma sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch | Other | Aligner use, Retainer use |
Primary outcome
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device
Time frame: 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
5 secondary outcomes
change in the amount of bacterias streptococcus mutans that adhere to biofilm od the teeth
Time frame: Baseline, 15 days, 30 days respectively
change in the amount of bacterias lactobacillus sp. that adhere to upper teeth
Time frame: Baseline, 15 days, 30 days, respectively
change in the amount of bacterias streptococcus mutans in the saliva
Time frame: Baseline, 15 days, 30 days, respectively
change in the amount of bacterias lactobacillus sp. in the saliva
Time frame: Baseline, 15 days, 30 days, respectively
Check any change in the epithelium
Time frame: Baseline, 15 days, 30 days, respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Background: PubMed 19726491Dincer 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.
- Background: PubMed 23540639do 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.
- Background: PubMed 21508267Jaderberg 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.
- Background: PubMed 21187528Low 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.
- Background: PubMed 24880842Mai 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.
- Background: PubMed 19828592Thickett 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.
- Background: PubMed 18407023Ziuchkovski 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.
- Background: PubMed 22554754Turkoz 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.
- Background: PubMed 15825788Turkkahraman 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.
- Background: PubMed 23786595Shpack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flares Baratto Filho, PhD study chair
Universidade Positivo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hours of use (Essix), collect saliva and collect biofilm in people with Malocclusion and Orthodontic Appliance Complication, run by Universidade Positivo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the amount of bacterias streptococcus mutans and lactobacillus sp. that adhere to thermoplastic device (time frame: baseline, 15 days, 30 days respectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427763, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.