Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 1

Conditions: Oral Hygiene; Caries, Dental; Plaque, Dental

Treatments: Drug: A standard children's toothpaste containing 1500 ppm fluoride; Drug: Livionex Dental Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04368533

17-22447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 9 months to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Livionex Dental Gel

Experimental group

Description:

Children assigned to this arm will brush/clean teeth with Livionex Dental Gel twice a day for up to 12 months.They 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. Data on compliance and side-effects of toothpastes will be collected at each of the calls.

Treatment:

Drug: Livionex Dental Gel

A standard children's toothpaste containing 1500 ppm fluoride

Active Comparator group

Description:

Children assigned to this arm will brush/clean teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months. They 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, 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 at each study visit. A monthly phone call will be made to assess compliance with the study protocol, and to answer any questions or concerns. Data on compliance and side-effects of toothpastes will be collected at each of the calls.

Treatment:

Drug: A standard children's toothpaste containing 1500 ppm fluoride