Assessment of a Probiotic to Treat Pediatric Gingivitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Lawson Health Research Institute
Sponsor:
Collaborators:
Integra Medical Inc.
University of Western Ontario, Canada
Ontario Centres of Excellence
Information provided by (Responsible Party):
Peter Cadieux, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01954849
First received: September 26, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

This study investigates the efficacy of a probiotic formulation (Lorodent) of 6 strains of bacteria (Streptococcus salivarius K12, Lactobacillus paracasei Lpc-37, L. plantarum Lp2001, L. salivarius Ls-33, L. acidophilus La-14, and L. reuteri Lru-1038),in reducing the inflammation and gingivitis in subjects between the ages of 8-14 years. Patients diagnosed with mild to moderate gingivitis based on a gingival index score will be recruited and receive a daily dose of the probiotic formulation following brushing or a placebo control for 30 days. They will be assessed for a gingivitis score, gum bleeding score, plaque score, their periodontal health and for precarious areas 14 days throughout a 28 day treatment and for a 28 day post treatment period. Additionally plaque and salvia samples will be analyzed for changes in microbial pathogens or inflammatory cytokines.


Condition Intervention Phase
Gingivitis
Inflammation
Dietary Supplement: Probiotic formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Reduction in gingivitis [ Time Frame: 14, 28, 42 and 56 days ] [ Designated as safety issue: No ]

    Gingivitis will be assessed by gingival index:

    0 Normal gingival

    1. Mild inflammation: slight change in color and slight edema and glazing; bleeding on probing
    2. Moderate inflammation: redness, edema and glazing; bleeding on probing
    3. Severe inflammation: marked redness and edema, ulceration; tendency to spontaneous bleeding.

    Significant reduction or change in any of these categories over time will be assessed.



Secondary Outcome Measures:
  • Reduced plaque [ Time Frame: 14, 28, 42 and 56 days ] [ Designated as safety issue: No ]
    Reduction in levels of plaque as measured by a plaque score

  • Reduction in inflammation [ Time Frame: 14, 28, 42 and 56 days ] [ Designated as safety issue: No ]
    Reduction in salivary cytokines IL-1, IL-6, IL-8, TNF-A, IL-12 and an increase in IL-10, and IL-13 as measured by immunofluorometric assay.


Other Outcome Measures:
  • Reduction in S. mutans [ Time Frame: 14, 28, 42 and 56 days ] [ Designated as safety issue: No ]
    Reduced levels of S. mutans in plaque and saliva


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lorodent (probiotic formulation)
Lorodent, at least 1 billion total CFU, taken once daily following tooth brushing in a probiotic chewable lozenge.
Dietary Supplement: Probiotic formulation
Other Name: Lorodent
Placebo Comparator: Placebo
Lozenge taken once daily after brushing.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Have mild to moderate gingivitis as determined by dentist (GI of 1 or 2)

Exclusion Criteria:

  • Unable to make informed consent
  • Subjects with allergies to milk or milk products, gluten or soy
  • Immune compromised
  • Major underlining medical condition
  • Pregnancy
  • Other oral disease such as existing periodontal disease, severe dental caries
  • Recent or planned surgery of any kind (major or minor)
  • ENT health problems
  • Medications (antibiotics, anti-inflammatory) that can influence the outcome.
  • Ongoing or recent (within 2 weeks) use of probiotics unrelated to the study
  • Participation in a clinical trial within 30 days prior to randomization.
  • Have within the past 30 days experienced any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
  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: NCT01954849

Contacts
Contact: Carine Bourassa, DDS (519) 661-2111 ext 88851 dr.cbourassa@live.ca

Locations
Canada, Ontario
University of Western Ontario Orthodontics Clinic Recruiting
London, Ontario, Canada, N6A 5C1
Contact: Sahza Hatibovic-Kofman, DDS, MDSc, PhD    (519) 661-4098    sahza.kofman@schulich.uwo.ca   
Contact: Fernando Inocencio, DDS, MDSc    (519) 661-4067    inocencio@schulich.uwo.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Integra Medical Inc.
University of Western Ontario, Canada
Ontario Centres of Excellence
Investigators
Principal Investigator: Peter Cadieux, PhD University of Western Ontario, Canada
Study Director: Sahza Hatibovic-Kofman, PhD, MDSc, DDS. University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Peter Cadieux, Adjunct Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01954849     History of Changes
Other Study ID Numbers: LG-001, 185428, TPS 11235
Study First Received: September 26, 2013
Last Updated: September 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
gingivitis
inflammation
plaque
orthodontics

Additional relevant MeSH terms:
Gingivitis
Inflammation
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014