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NCT Number: NCT01954849

Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque, Amyloid Stomatognathic Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Toronto Orthodontics Clinic

Toronto, Ontario, M5S 2J7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic formulation

Dietary Supplement

Primary outcomes

  1. Reduction in gingivitis

    Time frame: 0, 14, 28, and 56 days

    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 outcomes

  1. 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

    • - 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

  2. 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.

Other outcomes

  1. Reduction in S. mutans

    Time frame: 0, 14, 28, and 56 days

    Reduced levels of S. mutans in plaque and saliva

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Integra Medical Inc.
  • Ontario Centres of Excellence
  • University of Toronto
  • University of Western Ontario, Canada

Registry information

Official study title

Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2013
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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