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Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

Primary Purpose

Gingivitis, Inflammation

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Probiotic formulation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, inflammation, plaque, orthodontics

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Toronto Orthodontics Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic formulation

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Reduction in gingivitis
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.

Secondary Outcome Measures

Reduced plaque
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
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.

Full Information

First Posted
September 26, 2013
Last Updated
August 17, 2015
Sponsor
Lawson Health Research Institute
Collaborators
Integra Medical Inc., University of Toronto, University of Western Ontario, Canada, Ontario Centres of Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT01954849
Brief Title
Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients
Official Title
Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Integra Medical Inc., University of Toronto, University of Western Ontario, Canada, Ontario Centres of Excellence

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Inflammation
Keywords
gingivitis, inflammation, plaque, orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic formulation
Arm Type
Experimental
Arm Description
Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic formulation
Primary Outcome Measure Information:
Title
Reduction in gingivitis
Description
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.
Time Frame
0, 14, 28, and 56 days
Secondary Outcome Measure Information:
Title
Reduced plaque
Description
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
Time Frame
0, 14, 28, and 56 days
Title
Reduction in inflammation
Description
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.
Time Frame
0, 14, 28, and 56 days
Other Pre-specified Outcome Measures:
Title
Reduction in S. mutans
Description
Reduced levels of S. mutans in plaque and saliva
Time Frame
0, 14, 28, and 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cadieux, PhD
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Siew-Ging Gong, BDS, MS, MA, PhD.
Organizational Affiliation
University of Toronto, Canada
Official's Role
Study Director
Facility Information:
Facility Name
University of Toronto Orthodontics Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2J7
Country
Canada

12. IPD Sharing Statement

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Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

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