Effects of Probiotic Therapy in the Treatment of Periodontitis.

NCT03408548 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 06278012.1.0000.5419
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of the probiotic therapy as an adjunct to non-surgical periodontal treatment in patients diagnosed with Generalized Chronic Periodontitis. Clinical study's hypothesis is that with the use of probiotic therapy, the standard treatment could be enhance.

Conditions

Periodontitis; Probiotics

Keywords

Bifidobacterium animalis subsp. lactis; Probiotic; Periodontitis treatment; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Changes in probing depth.

  millimeter.

  Baseline, 30 days, 90 days.

Secondary Outcomes (7)

• Changes in plaque index.

  Baseline, 30 days, 90 days.

• Changes in the levels of interleukin(IL)-1βeta, IL-8 and IL-10 in the gingival crevicular fluid.

  Baseline, 30 days, 90 days.

• Changes in the levels of immunoglobulin A in saliva.

  Baseline, 30 days, 90 days.

• Changes in the subgingival microbiota.

  Baseline, 30 days, 90 days.

• Changes in the expression of beta-defensin-3, toll like receptor-4, cluster of differentiation (CD)-4 and CD-8.

  Baseline, 30 days.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Scaling root planning + two lozenge per day not containing Bifidobacterium animalis lactis HN019 for 30 days.

Procedure: Scaling root planning; Other: Placebo

Probiotic

EXPERIMENTAL

Scaling root planning + two lozenge per day containing Bifidobacterium animalis lactis HN019 (10x9 colony-forming units) for 30 days.

Procedure: Scaling root planning; Dietary Supplement: Probiotic

Interventions

Scaling root planning PROCEDURE

Periodontal treatment

Placebo; Probiotic

Probiotic DIETARY_SUPPLEMENT

two lozenge per day containing Bifidobacterium animalis lactis HN019

Probiotic

Placebo OTHER

two lozenge per day not containing Bifidobacterium animalis lactis HN019

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 30 years old
• All patients must present good general health.
• Previously untreated periodontitis
• Minimum of 15 teeth

You may not qualify if:

• Having received antibiotics for any purpose within 6 months prior to entering the study or the need for antibiotic coverage for dental treatment
• Pregnancy and nursing
• Acute oral lesions or necrotizing ulcerative periodontitis,
• A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, immunological diseases or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
• Current smoker or former smoker

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

School of Dentistry of Ribeirão Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (5)

• Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29.

  PMID: 26427036 BACKGROUND

• Matsubara VH, Bandara HM, Ishikawa KH, Mayer MP, Samaranayake LP. The role of probiotic bacteria in managing periodontal disease: a systematic review. Expert Rev Anti Infect Ther. 2016 Jul;14(7):643-55. doi: 10.1080/14787210.2016.1194198. Epub 2016 Jun 3.

  PMID: 27224284 BACKGROUND

• Messora MR, Oliveira LF, Foureaux RC, Taba M Jr, Zangeronimo MG, Furlaneto FA, Pereira LJ. Probiotic therapy reduces periodontal tissue destruction and improves the intestinal morphology in rats with ligature-induced periodontitis. J Periodontol. 2013 Dec;84(12):1818-26. doi: 10.1902/jop.2013.120644. Epub 2013 Jan 17.

  PMID: 23327675 BACKGROUND

• Invernici MM, Furlaneto FAC, Salvador SL, Ouwehand AC, Salminen S, Mantziari A, Vinderola G, Ervolino E, Santana SI, Silva PHF, Messora MR. Bifidobacterium animalis subsp lactis HN019 presents antimicrobial potential against periodontopathogens and modulates the immunological response of oral mucosa in periodontitis patients. PLoS One. 2020 Sep 22;15(9):e0238425. doi: 10.1371/journal.pone.0238425. eCollection 2020.

  PMID: 32960889 DERIVED

• Invernici MM, Salvador SL, Silva PHF, Soares MSM, Casarin R, Palioto DB, Souza SLS, Taba M Jr, Novaes AB Jr, Furlaneto FAC, Messora MR. Effects of Bifidobacterium probiotic on the treatment of chronic periodontitis: A randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1198-1210. doi: 10.1111/jcpe.12995. Epub 2018 Sep 24.

  PMID: 30076613 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michel R Messora, Phd

  University of Sao Paulo - FORP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Periodontal clinical examination (pre- and post-intervention) will be conducted by a single trained and calibrated examiner, who will be blinded to the experimental groups of the study. The examiner will also be blinded to the microbiological and immunological evaluations. SRP procedures will be performed by specialist in Periodontics, trained for these purposes, who will also be blinded to the experimental groups of the study. The coded lozenge will be given to the examiner, who will distribute them to the patients and will not have any access to information regarding the content of the lozenge. In addition, the patients will be blinded to the content of the lozenge and the treatment assignment during the study. The meaning of each code number will be revealed by the study coordinator only after conducting the statistical analysis of the experimental data.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: According to a random numeric table generated by a computer software, the study coordinator will allocate each patient into one of the following groups: Control (Scaling and Root Planing - SRP) or Test (SRP + probiotic therapy). The subjects (Control group) will receive placebo lozenge. In the Test group, the lozenge will contain Bifidobacterium lactis HN019. Individuals will be instructed (immediately after the first session of mechanical instrumentation) to consume twice a day for 4 weeks by dissolving the lozenge before bedtime and when wake up. They will also be instructed not to consume other probiotic product during the study. Clinical, immunological and microbiological parameters will be assessed at baseline (pre-intervention) and after completion of non-surgical periodontal therapy 30 and 90 days.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 24, 2018
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 30, 2016
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)