Clinical trial NCT01954849: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Inflammation
Keywords: gingivitis
inflammation
plaque
orthodontics
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Integra Medical Inc.
name: University of Toronto
name: University of Western Ontario, Canada
name: Ontario Centres of Excellence
First posted: 2013-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in gingivitis
timeFrame: 0, 14, 28, and 56 days
Secondary outcomes:
measure: Reduced plaque
timeFrame: 0, 14, 28, and 56 days
measure: Reduction in inflammation
timeFrame: 0, 14, 28, and 56 days
Other outcomes:
measure: Reduction in S. mutans
timeFrame: 0, 14, 28, and 56 days
Locations:
city: Toronto
country: Canada
facility: University of Toronto Orthodontics Clinic
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Peter Cadieux, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Canada
name: Siew-Ging Gong, BDS, MS, MA, PhD.
role: STUDY_DIRECTOR
References: