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Orthodontic Appliance ComplicationPhase 2NCT04398511

L Brevis for Traumatic Oral Lesions in Orthodontic Patients

A Phase 2 study testing L brevis in people with Orthodontic Appliance Complication and Oral Mucositis, run by Universidade de Passo Fundo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: Traumatic oral lesions are common in the beginning of the orthodontic treatment, and pathogenic oral bacteria might be involved. We tested whether the probiotic Lactobacillus brevis CD2 (L brevis) is benefic in this condition. Read more about this study

Who is it for?
Ages 14 to 60 years
What is being tested?
L brevis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteBrazil
Study dates
7 Jan 2019to 13 Dec 2019
Phase
Phase 2
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 14 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • need for orthodontic treatment with fixed appliance

Who cannot join

  • Oral lesions
  • Uncompensated systemic diseases
  • Regular use of corticoids, antibiotics, immuno regulators and antidepressive agents

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Post-Graduate Program in Dentistry

    Passo Fundo, 99052-900

Other trials in Brazil

About this study

Official title: The Effect of Lactobacillus Brevis CD2 on Traumatic Oral Lesions Induced by Fixed Orthodontic Appliance: a Randomized Clinical Trial

Introduction: Traumatic oral lesions are common in the beginning of the orthodontic treatment, and pathogenic oral bacteria might be involved. We tested whether the probiotic Lactobacillus brevis CD2 (L brevis) is benefic in this condition. Methods: In a double-blind clinical trial, 20 patients were randomized to 21 days course of lozenges containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch and dinner) or placebo, starting on the day of installation of the fixed orthodontic appliance. Main outcomes were days without oral lesions and oral pain score [ranging between 0 (no pain) and 10 (maximum)]. Oral health related quality of life was measured by OHIP-14 before and after treatments.

Read the detailed description

Study protocol After signing the informed consent form, the patients underwent an oral examination and answered about clinical information, oral pain scale, and the OHIP-14 questionnaire. The pain scale was graded between 0 (no pain) and 10 (maximum), Likert standard. There was also a drawing for the distribution of coded treatments, through a number taken by the patient from a manila envelope. After the orthodontic appliance installation session, each patient was instructed to use the coded treatment for the next 21 days, two gums after breakfast, after lunch and after dinner, totalizing 12 billion UFC of L brevis or placebo per day. The patient was provided with a diary to note the daily appearance of lesions and their evolution during the 21-day period, as well as the occurrence of any new symptoms (potential adverse effect), in addition to proof of the commitment assumed by the use of the tablets. After 21 days, each patient was reexamined by the author of the study, who collected the diaries and obtained information regarding the oral examination, oral pain scale, data on adherence to treatment and self-completion of the OHIP-14.

Statistical analysis Quantitative data are described with mean and standard deviation (or standard error of the mean) or median and range, while qualitative data are displayed with absolute and relative frequencies. Student's t-test was used for comparison of quantitative data between groups, Wilcoxon-Mann-Whitney (WMW) test being employed when the assumptions for that test were not met. Exact chi-square and Fisher´s exact test (FET) were used for categorical data. Treatment effect on OHIP-14 was analyzed using a Generalize Estimating Equations (GEE) model with Poisson distribution and log link, the predictors being treatment, time (beginning and end of treatment) and interaction treatment*time. The analyses were performed with softwares GraphPrism version 4.0 and SPSS® (IBM SPSS statistics v18). Sample size was estimated using WinPEPI v11.65. The P value indicative of significance was < 0.05. Because the final outcome was prevention or mitigation (not maintenance or augmentation) of undesirable symptoms, one-tailed tests were used for comparisons between groups respect to days without oral lesions, oral pain and OHIP-14 scores.

Being tested
L brevis, Placebo
Keywords
Fixed orthodontic appliance, Lactobacillus brevis CD2, Oral pain, Traumatic oral lesions
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L brevisDrug

    Also called Oral probiotic

    Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.

  • PlaceboDrug

    Placebo lozenges after breakfast, lunch and dinner for 21 days.

Study groups in NCT04398511
Study groupRoleWhat they receive
L brevisExperimentalLactobacillus brevis CD2 in lozenges containing 4 billion CFU. Patients used a lozenge 15 min after breakfast, lunch and dinner, during 21 days, starting in the day of installation of the orthodontic appliance.
Receives: Drug: L brevis
PlaceboPlacebo comparatorPlacebo in lozenges, identical to those of L brevis. Patients used a lozenge 15 min after breakfast, lunch and dinner, during 21 days, starting in the day of installation of the orthodontic appliance.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days without traumatic oral lesions

    Oral lesions (ulcers) due to fixed orthodontic appliance

    Measured: First 21 days after appliance installation

  2. Oral pain scale

    Oral pain score measured by Likert scale between 0 (no pain) and 10 (maximum pain)

    Measured: First 21 days after appliance installation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start7 Jan 2019
  3. Primary completion29 Nov 2019
  4. Study completion13 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled, clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398511
Sponsor's protocol ID
University of Passo Fundo
Status last verified
May 2020
First submitted
16 May 2020
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rennick LA, Campbell PM, Naidu A, Taylor RW, Buschang PH. Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients: A randomized controlled trial. Angle Orthod. 2016 May;86(3):351-7. doi: 10.2319/050415-303.1. Epub 2015 Sep 24.

    PubMed 26401826

  • Kluemper GT, Hiser DG, Rayens MK, Jay MJ. Efficacy of a wax containing benzocaine in the relief of oral mucosal pain caused by orthodontic appliances. Am J Orthod Dentofacial Orthop. 2002 Oct;122(4):359-65. doi: 10.1067/mod.2002.126405.

    PubMed 12411880

  • Bagatin CR, Andrucioli MCD, Ferreira JTL, Matsumoto MAN, da Silva RAB, da Silva LAB, Romano FL, Nelson-Filho P. Biofilm formation in Haas palatal expanders with and without use of an antimicrobial agent: an in situ study. Microsc Res Tech. 2017 May;80(5):471-477. doi: 10.1002/jemt.22817. Epub 2016 Dec 9.

    PubMed 27935660

  • Gizani S, Petsi G, Twetman S, Caroni C, Makou M, Papagianoulis L. Effect of the probiotic bacterium Lactobacillus reuteri on white spot lesion development in orthodontic patients. Eur J Orthod. 2016 Feb;38(1):85-89. doi: 10.1093/ejo/cjv015. Epub 2015 Apr 3.

    PubMed 25840585

  • Anusha RL, Umar D, Basheer B, Baroudi K. The magic of magic bugs in oral cavity: Probiotics. J Adv Pharm Technol Res. 2015 Apr-Jun;6(2):43-7. doi: 10.4103/2231-4040.154526.

    PubMed 25878972

  • Haukioja A. Probiotics and oral health. Eur J Dent. 2010 Jul;4(3):348-55.

    PubMed 20613927

  • Rastogi P, Saini H, Dixit J, Singhal R. Probiotics and oral health. Natl J Maxillofac Surg. 2011 Jan;2(1):6-9. doi: 10.4103/0975-5950.85845.

    PubMed 22442601

  • Riccia DN, Bizzini F, Perilli MG, Polimeni A, Trinchieri V, Amicosante G, Cifone MG. Anti-inflammatory effects of Lactobacillus brevis (CD2) on periodontal disease. Oral Dis. 2007 Jul;13(4):376-85. doi: 10.1111/j.1601-0825.2006.01291.x.

    PubMed 17577323

  • Sharma A, Rath GK, Chaudhary SP, Thakar A, Mohanti BK, Bahadur S. Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study. Eur J Cancer. 2012 Apr;48(6):875-81. doi: 10.1016/j.ejca.2011.06.010. Epub 2011 Jul 6.

    PubMed 21741230

  • Sharma A, Tilak T, Bakhshi S, Raina V, Kumar L, Chaudhary S, Sahoo R, Gupta R, Thulkar S. Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation. ESMO Open. 2017 Feb 13;1(6):e000138. doi: 10.1136/esmoopen-2016-000138. eCollection 2016.

    PubMed 28848667

  • Lee JK, Kim SJ, Ko SH, Ouwehand AC, Ma DS. Modulation of the host response by probiotic Lactobacillus brevis CD2 in experimental gingivitis. Oral Dis. 2015 Sep;21(6):705-12. doi: 10.1111/odi.12332. Epub 2015 Apr 20.

    PubMed 25720615

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L brevis in people with Orthodontic Appliance Complication and Oral Mucositis, run by Universidade de Passo Fundo 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 1 inclusion and 3 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 21 May 2020. 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. Some participants in this study may receive a placebo. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of days without traumatic oral lesions (time frame: First 21 days after appliance installation). The study lists 2 primary outcomes in all. 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 NCT04398511, which also lists 11 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 21 May 2020.

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