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AzTrials

PeriodontitisPhase 2NCT03408548

Effects of Probiotic Therapy in the Treatment of Periodontitis.

A Phase 2 study testing Scaling root planning and Probiotic in people with Periodontitis and Probiotics, run by University of Sao Paulo 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

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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Periodontitis, Probiotics
What is being tested?
Scaling root planning and Probiotic
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteBrazil
Study dates
1 Dec 2015to 30 Aug 2016
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • School of Dentistry of Ribeirão Preto - University of Sao Paulo

    Ribeirão Preto, São Paulo, 14040-904

Other trials in Brazil

About this study

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

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.

Read the detailed 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).

Being tested
Scaling root planning, Probiotic, Placebo
Keywords
Bifidobacterium animalis subsp. lactis, Probiotic, Periodontitis treatment, Periodontitis
Medical subject headings
Periodontitis

What participants receive

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

  • Scaling root planningProcedure or surgery

    Periodontal treatment

  • ProbioticDietary supplement

    two lozenge per day containing Bifidobacterium animalis lactis HN019

  • PlaceboOther

    two lozenge per day not containing Bifidobacterium animalis lactis HN019

Study groups in NCT03408548
Study groupRoleWhat they receive
PlaceboPlacebo comparatorScaling root planning + two lozenge per day not containing Bifidobacterium animalis lactis HN019 for 30 days.
Receives: Procedure: Scaling root planning; Other: Placebo
ProbioticExperimentalScaling root planning + two lozenge per day containing Bifidobacterium animalis lactis HN019 (10x9 colony-forming units) for 30 days.
Receives: Procedure: Scaling root planning; Dietary Supplement: Probiotic

What is being measured

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

  1. Changes in probing depth.

    millimeter.

    Measured: Baseline, 30 days, 90 days.

Secondary outcomes (7)

  1. Changes in plaque index.

    sites.

    Measured: Baseline, 30 days, 90 days.

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

    pg/ml.

    Measured: Baseline, 30 days, 90 days.

  3. Changes in the levels of immunoglobulin A in saliva.

    mg/dL.

    Measured: Baseline, 30 days, 90 days.

  4. Changes in the subgingival microbiota.

    mean count.

    Measured: Baseline, 30 days, 90 days.

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

    cells/mm2

    Measured: Baseline, 30 days.

  6. Changes in the attachment level.

    millimeter.

    Measured: Baseline, 30 days, 90 days.

  7. Changes in bleeding on probing.

    sites.

    Measured: Baseline, 30 days, 90 days.

Timeline

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

  1. First posted24 Jan 2018
  2. Study start1 Dec 2015
  3. Primary completion1 May 2016
  4. Study completion30 Aug 2016

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03408548
Sponsor's protocol ID
06278012.1.0000.5419
Status last verified
Jan 2018
First submitted
11 Jan 2018
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 26427036

  • 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.

    PubMed 27224284

  • 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.

    PubMed 23327675

  • 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.

    PubMed 32960889

  • 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.

    PubMed 30076613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Scaling root planning and Probiotic in people with Periodontitis and Probiotics, run by University of Sao Paulo 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 4 inclusion and 5 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 25 Jan 2018. 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?

Changes in probing depth. (time frame: Baseline, 30 days, 90 days.). 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 NCT03408548, which also lists 5 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 25 Jan 2018.

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