Effects of Probiotic Therapy in the Treatment of Periodontitis.

Periodontitis Clinical Trial

Official title:

Effects of Probiotic Therapy in the Treatment of Periodontitis: a Study of Clinical, Microbiological and Immunological Profile of the Host Response.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408548
• Other study ID #: 06278012.1.0000.5419
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2018
• Last updated: January 23, 2018
• Start date: December 1, 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Before the study begins, the selected individuals will be identified by a numeric code and will receive instructions regarding oral hygiene as well as supragingival scaling in all teeth. 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 (Test and Control groups) will receive lozenge containing/not containing. In the Test group, the lozenge will present Bifidobacterium lactis HN019 (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. All patients will receive detailed information regarding the study (goals, benefits and risks) according to the Term of Consent. The sample size was determined using the software Graphpad Statemate 2.0 (GraphPad Software, Inc., San Diego, CA, USA). The ideal sample size to ensure an 80% power in the statistical analysis of the data obtained in this study was calculated considering the differences of means and standard deviations between the test and control groups of the study by Vivekananda et al. (2010). The α value was set at 0.05. The average dropout of patients in our previous studies (approximately 20%) was also considered to calculate the sample size. Thus, a sample size of at least 30 patients was considered appropriate for this study. The normality and homoscedasticity of the data obtained will be checked. Comparisons within groups and among groups at different time intervals will be performed through parametric or non-parametric appropriate tests. The significance level will be set at 5% in all tests. All calculations will be performed by SPSS software (SPSS, Chicago IL, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 30, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• More than 30 years old

• All patients must present good general health.

• Previously untreated periodontitis

• Minimum of 15 teeth

Exclusion Criteria:

• 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 de?ciencies, immunological diseases or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, ni?depine, chronic use of non-steroidal anti-in?ammatory drugs)

• Current smoker or former smoker

Related Conditions & MeSH terms

• Periodontitis
• Probiotics

Intervention

Procedure:
• Scaling root planning
Periodontal treatment

Dietary Supplement:
• Probiotic
two lozenge per day containing Bifidobacterium animalis lactis HN019

Other:
• Placebo
two lozenge per day not containing Bifidobacterium animalis lactis HN019

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirão Preto - University of Sao Paulo	Ribeirão Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Messora MR, Oliveira LF, Foureaux RC, Taba M Jr, Zangerônimo 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in probing depth.	millimeter.	Baseline, 30 days, 90 days.
Secondary	Changes in plaque index.	sites.	Baseline, 30 days, 90 days.
Secondary	Changes in the levels of interleukin(IL)-1ßeta, IL-8 and IL-10 in the gingival crevicular fluid.	pg/ml.	Baseline, 30 days, 90 days.
Secondary	Changes in the levels of immunoglobulin A in saliva.	mg/dL.	Baseline, 30 days, 90 days.
Secondary	Changes in the subgingival microbiota.	mean count.	Baseline, 30 days, 90 days.
Secondary	Changes in the expression of beta-defensin-3, toll like receptor-4, cluster of differentiation (CD)-4 and CD-8.	cells/mm2	Baseline, 30 days.
Secondary	Changes in the attachment level.	millimeter.	Baseline, 30 days, 90 days.
Secondary	Changes in bleeding on probing.	sites.	Baseline, 30 days, 90 days.