NCT01438333

Brief Summary

The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

3.5 years

First QC Date

September 13, 2011

Last Update Submit

June 16, 2015

Conditions

Chronic Periodontitis

Keywords

Chronic Peridodontitisprobioticslactobacillus brevisfull mouth disinfection

Outcome Measures

Primary Outcomes (3)

  • Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs)

    6 weeks

  • Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)

    6 weeks

  • Comparison in saliva samples of the levels of metabolic phenotype

    6 weeks

Secondary Outcomes (6)

  • Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity;

    6 weeks

  • Comparison in saliva samples of the levels of Arginine deiminase

    6 weeks

  • Comparison in saliva samples of the levels of lactoferrin

    6 weeks

  • Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola)

    6 weeks

  • Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide)

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Lactobacillus brevis

EXPERIMENTAL
Dietary Supplement: lactobacillus brevis tablets

Placebo

PLACEBO COMPARATOR

5 tablets a day for 6 weeks

Dietary Supplement: PLACEBO

Interventions

lactobacillus brevis tabletsDIETARY_SUPPLEMENT

5 tablets a day for 6 weeks

Also known as: Inersan
Lactobacillus brevis
PLACEBODIETARY_SUPPLEMENT

5 tablets a day for 6 weeks

Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 21-70 years of age groups;
  • patients with chronic periodontitis in need of primary treatment;
  • patients with at least 20 fully erupted teeth;
  • patients ready to give written informed consent for participating in the trial;
  • patients agreeing to comply with the study protocol and instructions.

You may not qualify if:

  • Pregnant women and lactating mothers;
  • patients with debilitating systemic diseases;
  • patients in needs for prophylactic antibiotics;
  • patients treated with antibiotics within 30 days prior to enrollment into the study;
  • patients already participant any other clinical trial or participant other investigational drug, or food supplement, in the last 30 days;
  • patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis;
  • patients not willing to participate in the trial.
  • patients with psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of L'Aquila, Division of Periodontology

L’Aquila, AQ, 67100, Italy

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ENRICO MARCHETTI, DDS

    University of L'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 17, 2015

Record last verified: 2015-06

Locations

IT(1)