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

NCT01778699 | Unknown Phase 4 DMC

• 1 other identifier: 2013_01_21_a
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries; Gingivitis

Keywords

Lactobacillus brevis CD2; caries incidence; plaque-pH

Outcome Measures

Primary Outcomes (1)

• Caries increment by ICDAS method

  ICDAS (International Caries Detection and Assessment System) index, Oral mucosa

  180 days

Secondary Outcomes (2)

• salivary mutans streptococci

  90 days

• plaque pH

  90 days

Study Arms (2)

Lozenges with Lactobacillus brevis CD2

EXPERIMENTAL

During the treatment phases subjects will use 2 lozenges a day.

Dietary Supplement: lozenges

Lozenges

PLACEBO COMPARATOR

During the treatment phases subjects will use 2 lozenges a day.

Dietary Supplement: lozenges

Interventions

lozenges DIETARY_SUPPLEMENT

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).

Lozenges; Lozenges with Lactobacillus brevis CD2

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[Campus et al., 2009\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• University of Milan: collaborator
• Göteborg University: collaborator

Study Sites (1)

Department of Surgery, Microsurgery and Medicine Sciences -School of Dentistry University of sassari

Sassari, SS, 07100, Italy

RECRUITING

MeSH Terms

Conditions

Dental Caries; Gingivitis

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Giovanna Congiu, DDS PhD

CONTACT

giannicaro83@yahoo.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

IT (1)