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Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

This study has been completed.
Sponsor:
Collaborators:
Integra Medical Inc.
University of Toronto
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: December 19, 2014
Last verified: December 2014
  Purpose

This study investigates the efficacy of Lorodent, a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment (Lorodent) or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/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: 0, 14, 28, and 56 days ] [ Designated as safety issue: No ]

    Gingivitis will be assessed by gingival index:

    0 - Absence of gingival inflammation

    1. - Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit
    2. - Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit
    3. - Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit
    4. - Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.


Secondary Outcome Measures:
  • Reduced plaque [ Time Frame: 0, 14, 28, and 56 days ] [ Designated as safety issue: No ]

    Reduction in levels of plaque as measured by a plaque index:

    0 - No plaque in the gingival area

    1. - A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. Only seen by running a probe across the tooth surface
    2. - Moderate accumulation of plaque deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye
    3. - Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface

  • Reduction in inflammation [ Time Frame: 0, 14, 28, 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: 0, 14, 28, and 56 days ] [ Designated as safety issue: No ]
    Reduced levels of S. mutans in plaque and saliva


Enrollment: 60
Study Start Date: August 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lorodent (probiotic formulation)
Lorodent dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
Dietary Supplement: Probiotic formulation
Other Name: Lorodent
Placebo Comparator: Placebo
Placebo dissolving lozenge, with the exact same appearance as the treatment lozenge (including flavour, colour, shape and texture), and formulated with all the same ingredients except for the live bacteria, taken for 28 days at the same prescribed regimen as the probiotic lozenge.
Dietary Supplement: Probiotic formulation
Other Name: Lorodent

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Are male or female between the ages of 11 to 18 years
  • Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2)
  • Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months.
  • Have fully erupted teeth #16, #21, #23, #36, #41, and #43
  • Are caries inactive prior to study initiation.
  • Are in a healthy systemic condition
  • Have not used any antimicrobial mouth rinses, probiotics (unrelated to the study), antibiotics or anti-inflammatories medications with one month prior to and during the study
  • Whose legal guardian has given informed consent to participate in the study and must be able to communicate in English

Exclusion Criteria:

  • Unable to make informed consent
  • Subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in Lorodent
  • Immune compromised
  • Major underlining medical condition
  • Pregnancy
  • History of smoking or alcohol consumption
  • Have major dental conditions such as periodontal disease, dental caries and/or xerostemia or systemic diseases which could directly r indirectly affect plaque formation
  • Use of medications within 1 month (antibiotics, anti-inflammatory, mouth rinses) that can influence the outcome.
  • Ongoing or recent (within 1 month) use of probiotics unrelated to the study
  • 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

Locations
Canada, Ontario
University of Toronto Orthodontics Clinic
Toronto, Ontario, Canada, M5S 2J7
Sponsors and Collaborators
Lawson Health Research Institute
Integra Medical Inc.
University of Toronto
University of Western Ontario, Canada
Ontario Centres of Excellence
Investigators
Principal Investigator: Peter Cadieux, PhD University of Western Ontario, Canada
Study Director: Siew-Ging Gong, BDS, MS, MA, PhD. University of Toronto, 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, OCE VIP #20964
Study First Received: September 26, 2013
Last Updated: December 19, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on March 03, 2015