L Brevis for Traumatic Oral Lesions in Orthodontic Patients

NCT04398511 | Completed Phase 2

• 1 other identifier: University of Passo Fundo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication; Oral Mucositis; Bacterium; Agent

Keywords

Fixed orthodontic appliance; Lactobacillus brevis CD2; Oral pain; Traumatic oral lesions

Outcome Measures

Primary Outcomes (2)

• Number of days without traumatic oral lesions

  Oral lesions (ulcers) due to fixed orthodontic appliance

  First 21 days after appliance installation

• Oral pain scale

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

  First 21 days after appliance installation

Study Arms (2)

L brevis

EXPERIMENTAL

Lactobacillus 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.

Drug: L brevis

Placebo

PLACEBO COMPARATOR

Placebo 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.

Drug: Placebo

Interventions

L brevis DRUG

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

Also known as: Oral probiotic

L brevis

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• need for orthodontic treatment with fixed appliance

You may not qualify if:

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

Sponsors & Collaborators

• Universidade de Passo Fundo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Post-Graduate Program in Dentistry

Passo Fundo, 99052-900, Brazil

Location

Related Publications (11)

• 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.

  PMID: 26401826 BACKGROUND

• 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.

  PMID: 12411880 BACKGROUND

• 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.

  PMID: 27935660 BACKGROUND

• 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.

  PMID: 25840585 BACKGROUND

• 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.

  PMID: 25878972 BACKGROUND

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

  PMID: 20613927 BACKGROUND

• 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.

  PMID: 22442601 BACKGROUND

• 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.

  PMID: 17577323 BACKGROUND

• 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.

  PMID: 21741230 BACKGROUND

• 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.

  PMID: 28848667 BACKGROUND

• 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.

  PMID: 25720615 BACKGROUND

MeSH Terms

Conditions

Stomatitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fernando Fornari, Prof.

  University of Passo Fundo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients were treated with identical lozenges containing probiotic or placebo. The treatments were revealed only after statistical analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, double-blind, placebo-controlled, clinical trial

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 21, 2020
• Study Start: January 7, 2019
• Primary Completion: November 29, 2019
• Study Completion: December 13, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)