Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

Phase 2

Completed

• Conditions: Inflammation; Gingivitis
• Interventions: Dietary Supplement: Probiotic formulation

• Registration Number: NCT01954849
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-07
• Study Start: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic formulation	Probiotic formulation	Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
Placebo	Probiotic formulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

University of Toronto Orthodontics Clinic; 🇨🇦 Toronto, Ontario, Canada