Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

Phase 1

Completed

• Conditions: Caries, Dental; Oral Hygiene; Plaque, Dental
• Interventions: Drug: Livionex Dental Gel; Drug: A standard children's toothpaste containing 1500 ppm fluoride

• Registration Number: NCT04368533
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2019-01-25
• Study Start: 2019-02-08
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2020-08-21
• Study Completion: 2020-08-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Livionex Dental Gel	Livionex Dental Gel	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.
A standard children's toothpaste containing 1500 ppm fluoride	A standard children's toothpaste containing 1500 ppm fluoride	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.

Primary Outcome Measures

Name	Time	Method
Changes of dental plaque	up to 12 months	To compare plaque reduction between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months months. Plaque will be assessed using a plaque index score (Turesky modification of the Quigley-Hein Plaque Index) for each tooth and a total plaque score will be divided by the number of teeth present for analysis.
Incidence of new dental caries.	up to 12 months	To compare incidence of new dental caries between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months.
Changes of oral microbiome composition	up to 12 months	Using 16S rRNA gene sequences and taxonomic annotation to identify dental caries relevant pathogenic, commensal, and probiotic bacteria and archaea and to compare temporal changes in oral microbiome composition, diversity and relative quantity between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months months.

Trial Locations

Locations (1)

UCSF Pediatric Dentistry Parnassus Clinic; 🇺🇸 San Francisco, California, United States