NCT01601145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

May 15, 2012

Last Update Submit

August 21, 2012

Conditions

Plaque Ph Lowering After Use of ProbioticsCariesGingivitis

Keywords

Lactobacillus Brevis CD2schoolchildrendental cariesGingivatis

Outcome Measures

Primary Outcomes (1)

  • Lower plaque acidogenicity

    The regular consumption of probiotic will lead to a significantly lower plaque acidogenicity compared to a placebo. Regular oral hygiene is permitted.

    2 months

Study Arms (2)

lozenges with Lactobacillus brevis CD2

EXPERIMENTAL

Randomized group using lozenges for 6 weeks.

Dietary Supplement: consumption of lozenges

lozenges

PLACEBO COMPARATOR

Randomized group using lozenges for 6 weeks.

Dietary Supplement: consumption of lozenges

Interventions

consumption of lozengesDIETARY_SUPPLEMENT

Each subject two lozenges a day for 6 weeks

lozengeslozenges with Lactobacillus brevis CD2

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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
  • At least on caries active lesion (d/D\>0)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sassari, Dept of Surgery, Microsurtgery and Medicine Sciences

Sassari, SS, 07100, Italy

Location

Related Publications (1)

  • Campus G, Cocco F, Carta G, Cagetti MG, Simark-Mattson C, Strohmenger L, Lingstrom P. Effect of a daily dose of Lactobacillus brevis CD2 lozenges in high caries risk schoolchildren. Clin Oral Investig. 2014;18(2):555-61. doi: 10.1007/s00784-013-0980-9. Epub 2013 May 5.

    PMID: 23644602DERIVED

MeSH Terms

Conditions

GingivitisDental Caries

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Study Officials

  • Guglielmo Campus

    University of Sassari, Dept of Surgery, Microsurgery and Medicine Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Community Dentistry

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

IT(1)