Trial record 9 of 17 for:    Open Studies | "Gingival Diseases"

Assessment of a Probiotic to Treat Pediatric Gingivitis

This study is currently recruiting participants.
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
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 April 17, 2014