Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children
Condition: Plaque, Dental; Caries, Dental; Oral Hygiene
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional

Summary: 
      This is an investigator initiated randomized double-blind pilot study at the UCSF Pediatric
      Dental Clinics to compare effectiveness of a new toothpaste Livionex Dental Gel with a
      standard children's toothpaste containing 1500 ppm fluoride in reducing dental plaque and
      caries in healthy and well children every 3 months for up to 12 months.
    

Detailed description: 
      Dental plaque is the primary etiological factor in the initiation of caries, gingival
      inflammation and subsequent destruction of periodontal tissues. Effective oral hygiene
      eliminates microbial plaque leading to resolution of gingival inflammation. Livionex Dental
      Gel is a toothpaste that is effective in reducing plaque in adults while not containing the
      additives found in other toothpastes that can cause increased gingival irritation. The
      investigators hypothesize that brushing with Livionex toothpaste creates an oral environment
      that prevents dental plaque accumulation and promotes oral health in children.

      This study will prospectively enroll 78 children aged 9 months to 12 years from UCSF
      pediatric dental clinics. Upon obtaining an informed consent, children will be randomized in
      a 1:1 ratio to the use of test (Livionex Dental Gel) and control toothpaste (a standard
      children's toothpaste containing 1500 ppm fluoride ). All patients will be provided a soft
      brush at enrollment, and the child and/or the parent will be taught to brush/clean after the
      first exam, with the assigned dentifrice, at the study center before they go home.
      Additionally, each subject will receive a new brush at every 3-month visit. Subjects will
      undergo a dental exam by a trained dentist including caries assessment (at baseline, 1, 3, 6,
      9 or 12 months), dental plaque photograph, (at baseline, 1, 3, 6 and 9 or 12 months), and
      swab samples for dental plaque and saliva will be collected at all study visits. A
      questionnaire will be given to address dentifrice and brushing experience in a phone call one
      month after enrollment and at the last study visit. Data on compliance and side effects of
      toothpastes will be collected at each of the calls.
    

Intervention name(s): Livionex Dental Gel; A standard children's toothpaste containing 1500 ppm fluoride
Intervention type(s): Other; Other
Intervention description(s): The subjects will brush their teeth with Livionex Dental Gel twice a day for up to 12 months.; The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Livionex dental gel, toothpaste