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Chronic PeriodontitisPhase 2NCT02645669

Effect of a Locally Delivered Probiotic in Periodontitis

A Phase 2 study testing Study site in people with Chronic Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.

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

Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent in the context of pathogenic mechanisms in… Read more about this study

Who is it for?
Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
Study site
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIndia
Study dates
Feb 2014to Aug 2015
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 25 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects having at least one pocket ≥5 mm in each quadrant were included in the study.

Who cannot join

  • Medically compromised patients and patients having received any form of surgical or non-surgical therapy in the 6 month period leading to the study were not included.

Trial locations and contacts

1 site in 1 country.

India1 site

  • SVS Institute of Dental Sciences, Mahabubnagar

    Hyderabad, Andhra Pradesh, 509002

Other trials in India

About this study

Official title: Effect of a Locally Delivered Probiotic as an Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis

Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent in the context of pathogenic mechanisms in periodontitis.

Read the detailed description

One method of altering the subgingival environment is by using probiotics. Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host by passively occupying a niche that may otherwise be colonized by pathogens. This tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence factors.8 In the past few years, probiotics have been investigated for periodontal health. Studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity by inhibiting pathogenic species. Teughels et al., in a study showed that application of beneficial oral bacteria subgingivally after scaling and root planing led to a more host compatible subgingival microbiota which may also effect the promotion of a beneficial host response.10 Studies have revealed that probiotic Lactobacillus strains (L. reuteri, L salivarius, L. casei, L. acidophilus) were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis, in the saliva and subgingival plaque. Streptococcus sanguinis \& S. uberis were found to inhibit the growth of periodontopathogens \& a strong negative between Aggregatibacter actinomycetemcomitans and S. sanguinis. Weissella cibaria isolates in the form of probiotic rinse possess the ability to inhibit biofilm formation, both in vitro and in vivo.

Being tested
Study site, Control site
Medical subject headings
Chronic Periodontitis

What participants receive

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

  • Study siteProcedure or surgery

    The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.

  • Control siteProcedure or surgery

    Only Scaling and Root planing was done.

Study groups in NCT02645669
Study groupRoleWhat they receive
Study siteExperimentalScaling and Root planing (SRP) was followed by placement of S boulardii-FOS mixture
Receives: Procedure: Study site
Control sitePlacebo comparatorOnly Scaling and Root planing (SRP) was performed
Receives: Procedure: Control site

What is being measured

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

  1. In vitro Estimation of S. boulardii viability

    S boulardii-FOS mixture was stored for 3 weeks at 25ºC for periodic analysis (upto14 days) of microorganism viability on a selective medium. Briefly, the mixture was plated on Sabouraud's agar plates at 30°C and colony forming units (CFU) were enumerated after 24 to 48 h of incubation. Colonies were expressed as total log count per mg of sample (log10 CFU/mg).

    Measured: up to 14 days

  2. Viability of the probiotic mixture in the periodontal pocket

    Viable cell count was determined by serial dilution method on Emmons' modification of Sabouraud's agar medium and colonies were expressed as total log count per ml of sample (log10 CFU/ml). Only colonies that were opaque, light brown, smooth and 2-3 mm in diameter were counted.

    Measured: up to 7 days

Secondary outcomes (4)

  1. GI

    Gingivitis (Modified gingival index; MGI) was measured at baseline and up to 6 months after treatment.

    Measured: up to 6 months

  2. PI

    Plaque (Plaque index; PI) was measured at baseline and up to 6 months after treatment.

    Measured: up to 6 months

  3. PPD

    Probing pocket depth (in mm) was measured at baseline and up to 6 months after treatment.

    Measured: up to 6 months

  4. CAL

    Clinical Attachment Level (CAL) was measured at baseline and up to 6 months after treatment.

    Measured: up to 6 months

Timeline

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

  1. First posted5 Jan 2016 (estimated)
  2. Study startFeb 2014
  3. Primary completionMar 2015
  4. Study completionAug 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645669
Sponsor's protocol ID
SVSIDS/PERIO/2/2014
Other IDs
D139406038
Status last verified
Dec 2015
First submitted
21 Dec 2015
Last updated
5 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Data will be shared after publishing the study.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Study site in people with Chronic Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.

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 1 inclusion and 1 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 5 Jan 2016. 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 India. 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?

In vitro Estimation of S. boulardii viability (time frame: up to 14 days). The study lists 2 primary outcomes in all. 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 NCT02645669.

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 5 Jan 2016.

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