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Effect of Probiotic on the Plaque pH. A Randomized Double Blind Interventional Study

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ClinicalTrials.gov Identifier: NCT01601145
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari

Brief Summary:
The aim of the present research protocol was to evaluate the effect of probiotics daily used, on the plaque acidogenicity of children. The null hypothesis was that the plaque acidogenicity would remain unchanged and not associate with the use of probiotics. Moreover, the in situ study will be carried out to investigate the plaque formation as biofilm in demineralised enamel specimens following the regular consumption of a probiotic product compared to a control group. Metabolic of the biofilm formed on of the enamel specimens resulting from the consumption will be evaluated over a period of 8 weeks.

Condition or disease Intervention/treatment Phase
Plaque Ph Lowering After Use of Probiotics Caries Gingivitis Dietary Supplement: consumption of lozenges Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: lozenges with Lactobacillus brevis CD2
Randomized group using lozenges for 6 weeks.
Dietary Supplement: consumption of lozenges
Each subject two lozenges a day for 6 weeks

Placebo Comparator: lozenges
Randomized group using lozenges for 6 weeks.
Dietary Supplement: consumption of lozenges
Each subject two lozenges a day for 6 weeks




Primary Outcome Measures :
  1. Lower plaque acidogenicity [ Time Frame: 2 months ]
    The regular consumption of probiotic will lead to a significantly lower plaque acidogenicity compared to a placebo. Regular oral hygiene is permitted.



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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • At least on caries active lesion (d/D>0)

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.
  • Use of fluoride-containing products (pastes, mouthrinses) within the 14 days prior to the introduction of the intra-oral appliances.
  • Use of fluoride-containing products: gels, tablets, varnishes, fillings etc. or of erosive broncholytics or antiasthmatics within 30 days prior to the introduction of the intra-oral specimen holder.
  • Antibiotic therapy within the past six months.
  • Any non-permitted therapy.

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): NCT01601145


Locations
Italy
University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences
Sassari, SS, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
Principal Investigator: Guglielmo Campus University of Sassari, Dept of Surgery, Microsurgery and Medicine Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guglielmo Campus, Associate Professor of Community Dentistry, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01601145     History of Changes
Other Study ID Numbers: 146/2011
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Guglielmo Campus, Università degli Studi di Sassari:
Lactobacillus Brevis CD2
schoolchildren
dental caries
Gingivatis

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases