Anticaries Effect of Probiotic Lactobacillus Brevis CD2 (Lb CD2).

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Università degli Studi di Sassari
Sponsor:
Collaborators:
University of Milan
Göteborg University
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT01778699
First received: January 21, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

In a previous study the efficacy of Lb CD2 on interim covariates related to caries development was tested. So, it was decided to plan a new study on schoolchildren from the same area. The aim of the present research protocol was to evaluate the anticariogenic effect of probiotics daily used, on the caries development in children. The null hypothesis was that the probiotic Lb CD2 would not modify the caries risk of the children. Moreover, the study will be carried out to investigate the plaque acidogenicity in situ following the regular consumption of a probiotic product compared to a control group.

Objective: To determine the effect of a regularly consumed probiotic on the development of new caries lesions.

Study design: Double blind, placebo-controlled, longitudinal study, monocentric, national, in situ


Condition Intervention Phase
Dental Caries
Gingivitis
Dietary Supplement: lozenges
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anticaries Effect of Probiotic Lactobacillus Brevis CD2 (Lb CD2). A Randomized Double Blind Interventional Study.

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Sassari:

Primary Outcome Measures:
  • Caries increment by ICDAS method [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    ICDAS (International Caries Detection and Assessment System) index, Oral mucosa


Secondary Outcome Measures:
  • salivary mutans streptococci [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Saliva factors and flow rate will be measured each time in the morning.

  • plaque pH [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    plaque pH after a rinse with a 10% sucrose solution for 1 min. Measurements of plaque pH will be performed before and after 2, 5, 10, 15 and 30 minutes.


Estimated Enrollment: 440
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lozenges with Lactobacillus brevis CD2
During the treatment phases subjects will use 2 lozenges a day.
Dietary Supplement: lozenges

The test products for the study is manufactured and provided by CD Investments srl, Italy. The placebo lozenges will look like the active lozenges with the same taste and weight of 1 gram containing only the ingredients listed above in the same proportion as the active but with no L. brevis CD2. It will not be possible to differentiate the two products.

The study center and the monitor must be informed of any deficiency in the study products (products will be kept at 4° degrees during the study).

Placebo Comparator: Lozenges
During the treatment phases subjects will use 2 lozenges a day.
Dietary Supplement: lozenges

The test products for the study is manufactured and provided by CD Investments srl, Italy. The placebo lozenges will look like the active lozenges with the same taste and weight of 1 gram containing only the ingredients listed above in the same proportion as the active but with no L. brevis CD2. It will not be possible to differentiate the two products.

The study center and the monitor must be informed of any deficiency in the study products (products will be kept at 4° degrees during the study).


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written declaration of informed consent signed by parents/guardian
  • At least 20 teeth
  • Good general health, as assessed by investigator
  • Average oral hygiene (cleaning the teeth at least twice a day)
  • Agreement of test subject not to use any oral hygiene products other than the test products and toothpaste provided for the duration of the study; the use of non-fluoridated oral hygiene agents is allowed.
  • Flow rate of stimulated saliva ≥ 0.7 ml/min
  • High caries risk following Cariogram [Campus et al., 2009]

Exclusion Criteria:

  • Ongoing oral or dental treatment except for emergency treatment.
  • Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx.
  • Existing allergy to one of the components of the test products or the standard toothpaste.
  • Pathological changes of the oral mucosa, e.g. acute ulcerating gingivitis, acute herpetic gingivostomatitis, recurrent aphthous ulceration or systemic illnesses with oral manifestations.
  • Antibiotic therapy within the past six months, used for a period more than 10 days.
  • Any non-permitted therapy.
  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: NCT01778699

Contacts
Contact: Giovanna Congiu, DDS PhD giannicaro83@yahoo.it

Locations
Italy
Department of Surgery, Microsurgery and Medicine Sciences -School of Dentistry University of sassari Recruiting
Sassari, SS, Italy, 07100
Contact: Guglielmo Campus    +39 079 228540    gcampus@uniss.it   
Contact: Guglielmo Campus    +390 79 228540    gcampus@uniss.it   
Principal Investigator: Guglielmo Campus, DDS, PhD         
Sub-Investigator: Fabio Cocco, DCS, PhD         
Sub-Investigator: Giovanna Congiu, DDS PhD         
Sponsors and Collaborators
Università degli Studi di Sassari
University of Milan
Göteborg University
  More Information

No publications provided

Responsible Party: Guglielmo Campus, Associate Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01778699     History of Changes
Other Study ID Numbers: 2013_01_21_a
Study First Received: January 21, 2013
Last Updated: February 19, 2014
Health Authority: Italy: National Bioethics Committee

Keywords provided by Università degli Studi di Sassari:
Lactobacillus brevis CD2
caries incidence
plaque-pH

Additional relevant MeSH terms:
Dental Caries
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 21, 2014