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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of L'Aquila
Sponsor:
Information provided by (Responsible Party):
Enrico Marchetti, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01438333
First received: September 13, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Chronic Periodontitis
Dietary Supplement: lactobacillus brevis tablets
Dietary Supplement: PLACEBO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison in saliva samples of the levels of metabolic phenotype [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity; [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Comparison in saliva samples of the levels of Arginine deiminase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Comparison in saliva samples of the levels of lactoferrin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438333

Contacts
Contact: ENRICO MARCHETTI, DDS enrico.marchetti@cc.univaq.it
Contact: FABRIZIO SGOLASTRA, DDS fabriziosgolastra@gmail.com

Locations
Italy
University of L'Aquila, Division of Periodontology Recruiting
L'aquila, AQ, Italy, 67100
Contact: ENRICO MARCHETTI, DDS       enrico.marchetti@cc.univaq.it   
Contact: FABRIZIO SGOLASTRA, DDS       fabriziosgolastra@gmail.com   
Sponsors and Collaborators
University of L'Aquila
Investigators
Principal Investigator: ENRICO MARCHETTI, DDS University of L'Aquila
  More Information

No publications provided

Responsible Party: Enrico Marchetti, Adjunct Professor, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01438333     History of Changes
Other Study ID Numbers: 07/CE/2011
Study First Received: September 13, 2011
Last Updated: January 28, 2014
Health Authority: Italy: Ethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014