Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

NCT01954849 | Completed Phase 2

• 3 other identifiers: LG-001185428OCE VIP #20964
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

gingivitis; inflammation; plaque; orthodontics

Outcome Measures

Primary Outcomes (1)

• Reduction in gingivitis

  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.

  0, 14, 28, and 56 days

Secondary Outcomes (2)

• Reduced plaque

  0, 14, 28, and 56 days

• Reduction in inflammation

  0, 14, 28, and 56 days

Other Outcomes (1)

• Reduction in S. mutans

  0, 14, 28, and 56 days

Study Arms (2)

Probiotic formulation

EXPERIMENTAL

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

Dietary Supplement: Probiotic formulation

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

Placebo; Probiotic formulation

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Integra Medical Inc.: collaborator
• University of Toronto: collaborator
• University of Western Ontario, Canada: collaborator
• Ontario Centres of Excellence: collaborator

Study Sites (1)

University of Toronto Orthodontics Clinic

Toronto, Ontario, M5S 2J7, Canada

Location

MeSH Terms

Conditions

Gingivitis; Inflammation; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Peter Cadieux, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Siew-Ging Gong, BDS, MS, MA, PhD.

  University of Toronto, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 7, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

CA (1)