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Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01438333
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Periodontitis Dietary Supplement: lactobacillus brevis tablets Dietary Supplement: PLACEBO

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial
Study Start Date : September 2011
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lactobacillus brevis Dietary Supplement: lactobacillus brevis tablets
5 tablets a day for 6 weeks
Other Name: Inersan
Placebo Comparator: Placebo
5 tablets a day for 6 weeks
Dietary Supplement: PLACEBO
5 tablets a day for 6 weeks


Outcome Measures

Primary Outcome Measures :
  1. Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs) [ Time Frame: 6 weeks ]
  2. Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2) [ Time Frame: 6 weeks ]
  3. Comparison in saliva samples of the levels of metabolic phenotype [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity; [ Time Frame: 6 weeks ]
  2. Comparison in saliva samples of the levels of Arginine deiminase [ Time Frame: 6 weeks ]
  3. Comparison in saliva samples of the levels of lactoferrin [ Time Frame: 6 weeks ]
  4. Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola) [ Time Frame: 6 weeks ]
  5. Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide) [ Time Frame: 6 weeks ]
  6. Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438333


Locations
Italy
University of L'Aquila, Division of Periodontology
L'aquila, AQ, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Investigators
Principal Investigator: ENRICO MARCHETTI, DDS University of L'Aquila
More Information

Responsible Party: Enrico Marchetti, Adjunct Professor, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01438333     History of Changes
Other Study ID Numbers: 07/CE/2011
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015

Keywords provided by Enrico Marchetti, University of L'Aquila:
Chronic Peridodontitis
probiotics
lactobacillus brevis
full mouth disinfection

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases