Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

Oral Hygiene Clinical Trial

Official title:

A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368533
• Other study ID #: 17-22447
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: August 21, 2020

Study information

• Verified date: April 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 21, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries
• Dental Plaque
• Oral Hygiene
• Plaque, Dental

Intervention

Other:
• Livionex Dental Gel
The subjects will brush their teeth with Livionex Dental Gel twice a day for up to 12 months.
• A standard children's toothpaste containing 1500 ppm fluoride
The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months.

Locations

Country	Name	City	State
United States	UCSF Pediatric Dentistry Parnassus Clinic	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bowen WH, Koo H. Biology of Streptococcus mutans-derived glucosyltransferases: role in extracellular matrix formation of cariogenic biofilms. Caries Res. 2011;45(1):69-86. doi: 10.1159/000324598. Epub 2011 Feb 23. Review. — View Citation

Dadkhah M, Chung NE, Ajdaharian J, Wink C, Klokkevold P, Wilder-Smith P. Effects of a Novel Dental Gel on Plaque and Gingivitis: A Comparative Study. Dentistry (Sunnyvale). 2014 Jun 1;4(6):239. — View Citation

Pitts NB, Ekstrand KR; ICDAS Foundation. International Caries Detection and Assessment System (ICDAS) and its International Caries Classification and Management System (ICCMS) - methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol. 2013 Feb;41(1):e41-52. doi: 10.1111/cdoe.12025. Review. — View Citation

Raad II, Fang X, Keutgen XM, Jiang Y, Sherertz R, Hachem R. The role of chelators in preventing biofilm formation and catheter-related bloodstream infections. Curr Opin Infect Dis. 2008 Aug;21(4):385-92. doi: 10.1097/QCO.0b013e32830634d8. Review. — View Citation

Söderling E, Isokangas P, Pienihäkkinen K, Tenovuo J. Influence of maternal xylitol consumption on acquisition of mutans streptococci by infants. J Dent Res. 2000 Mar;79(3):882-7. — View Citation

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. — View Citation

van der Weijden GA, Hioe KP. A systematic review of the effectiveness of self-performed mechanical plaque removal in adults with gingivitis using a manual toothbrush. J Clin Periodontol. 2005;32 Suppl 6:214-28. Review. — View Citation

Wu H, Moser C, Wang HZ, Høiby N, Song ZJ. Strategies for combating bacterial biofilm infections. Int J Oral Sci. 2015 Mar 23;7(1):1-7. doi: 10.1038/ijos.2014.65. Review. — View Citation

Young DA, Featherstone JD. Caries management by risk assessment. Community Dent Oral Epidemiol. 2013 Feb;41(1):e53-63. doi: 10.1111/cdoe.12031. — View Citation

Zhan L, Cheng J, Chang P, Ngo M, Denbesten PK, Hoover CI, Featherstone JD. Effects of xylitol wipes on cariogenic bacteria and caries in young children. J Dent Res. 2012 Jul;91(7 Suppl):85S-90S. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of dental plaque	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.	up to 12 months
Primary	Incidence of new dental caries.	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.	up to 12 months
Primary	Changes of oral microbiome composition	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.	up to 12 months