Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

NCT ID: NCT01954849

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Gingivitis; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic formulation

Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.

Group Type: EXPERIMENTAL

Probiotic formulation

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: PLACEBO_COMPARATOR

Probiotic formulation

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Probiotic formulation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra Medical Inc.

INDUSTRY

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

Ontario Centres of Excellence

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Peter Cadieux

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Cadieux, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Siew-Ging Gong, BDS, MS, MA, PhD.

Role: STUDY_DIRECTOR

University of Toronto, Canada

Locations

University of Toronto Orthodontics Clinic

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

185428

Identifier Type: OTHER

Identifier Source: secondary_id

OCE VIP #20964

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LG-001

Identifier Type: -

Identifier Source: org_study_id