Gingivitis, Inflammation
Conditions
Keywords
gingivitis, inflammation, plaque, orthodontics
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic formulation
Sponsors
Integra Medical Inc.
University of Toronto
University of Western Ontario, Canada
Ontario Centres of Excellence
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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 the lozenge * 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 or 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in gingivitis | 0, 14, 28, and 56 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduced plaque | 0, 14, 28, and 56 days | 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 | 0, 14, 28, and 56 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction in S. mutans | 0, 14, 28, and 56 days | Reduced levels of S. mutans in plaque and saliva |
Countries
Canada
Outcome results
None listed