Clinical trial NCT04368533: Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children
Official title: A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque, Dental
Caries, Dental
Oral Hygiene
Keywords: Livionex dental gel, toothpaste
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 78
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 9 months to 12 years.
* Parent and children are able complete the study procedures.
* Parent/legal guardian willing to allow their child participate and sign informed consent form.

Exclusion Criteria:

* Parents are unable to understand or participate in study procedures.
* Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.

Primary outcomes:
measure: Changes of dental plaque
timeFrame: up to 12 months
measure: Incidence of new dental caries.
timeFrame: up to 12 months
measure: Changes of oral microbiome composition
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Pediatric Dentistry Parnassus Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pamela Den-Besten, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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