L Brevis for Traumatic Oral Lesions in Orthodontic Patients

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398511
• Other study ID #: University of Passo Fundo
• Status: Completed
• Phase: Phase 2
• Start date: January 7, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: May 2020
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 13, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

• need for orthodontic treatment with fixed appliance

Exclusion Criteria:

• Oral lesions

• Uncompensated systemic diseases

• Regular use of corticoids, antibiotics, immuno regulators and antidepressive agents

Related Conditions & MeSH terms

• Bacterium; Agent
• Mucositis
• Oral Mucositis
• Orthodontic Appliance Complication
• Stomatitis

Intervention

Drug:
• L brevis
Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.
• Placebo
Placebo lozenges after breakfast, lunch and dinner for 21 days.

Locations

Country	Name	City	State
Brazil	Post-Graduate Program in Dentistry	Passo Fundo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade de Passo Fundo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. Epub 2015 Apr 3. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sharma A, Tilak T, Bakhshi S, Raina V, Kumar L, Chaudhary SP, Sahoo RK, 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days without traumatic oral lesions	Oral lesions (ulcers) due to fixed orthodontic appliance	First 21 days after appliance installation
Primary	Oral pain scale	Oral pain score measured by Likert scale between 0 (no pain) and 10 (maximum pain)	First 21 days after appliance installation