Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients
This study investigates the efficacy of 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 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.
Dietary Supplement: Probiotic formulation
|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|
- 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
- - Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit
- - Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit
- - Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit
- - Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.
- 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
- - 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
- - 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
- - 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.
- 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
|Study Start Date:||August 2014|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Probiotic formulation
Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
|Dietary Supplement: Probiotic formulation|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954849
|University of Toronto Orthodontics Clinic|
|Toronto, Ontario, Canada, M5S 2J7|
|Principal Investigator:||Peter Cadieux, PhD||University of Western Ontario, Canada|
|Study Director:||Siew-Ging Gong, BDS, MS, MA, PhD.||University of Toronto, Canada|