- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954849
Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients
August 17, 2015 updated by: Peter Cadieux, Lawson Health Research Institute
Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2J7
- University of Toronto Orthodontics Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic formulation
Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days.
|
|
Placebo Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in gingivitis
Time Frame: 0, 14, 28, and 56 days
|
Gingivitis will be assessed by gingival index: 0 - Absence of gingival inflammation
|
0, 14, 28, and 56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduced plaque
Time Frame: 0, 14, 28, and 56 days
|
Reduction in levels of plaque as measured by a plaque index: 0 - No plaque in the gingival area
|
0, 14, 28, and 56 days
|
Reduction in inflammation
Time Frame: 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.
|
0, 14, 28, and 56 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in S. mutans
Time Frame: 0, 14, 28, and 56 days
|
Reduced levels of S. mutans in plaque and saliva
|
0, 14, 28, and 56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Cadieux, PhD, University of Western Ontario, Canada
- Study Director: Siew-Ging Gong, BDS, MS, MA, PhD., University of Toronto, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 26, 2013
First Submitted That Met QC Criteria
September 26, 2013
First Posted (Estimate)
October 7, 2013
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 17, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-001
- 185428 (Other Identifier: Health Canada, Natural Health Products Directorate)
- OCE VIP #20964 (Other Grant/Funding Number: Ontario Centres of Excellence)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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