Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

NCT04368533 | Completed Phase 1 FDA Drug

• 1 other identifier: 17-22447
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque, Dental; Caries, Dental; Oral Hygiene

Keywords

Livionex dental gel, toothpaste

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Livionex Dental Gel

EXPERIMENTAL

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.

Drug: Livionex Dental Gel

A standard children's toothpaste containing 1500 ppm fluoride

ACTIVE COMPARATOR

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.

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

Interventions

Livionex Dental Gel DRUG

The subjects will brush their teeth with Livionex Dental Gel twice a day for up to 12 months.

Livionex Dental Gel

A standard children's toothpaste containing 1500 ppm fluoride DRUG

The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months.

A standard children's toothpaste containing 1500 ppm fluoride

Eligibility Criteria

• Age: 9 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Pediatric Dentistry Parnassus Clinic

San Francisco, California, 94143, United States

Location

Related Publications (10)

• 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. doi: 10.4172/2161-1122.1000239.

  PMID: 26052472 BACKGROUND

• 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.

  PMID: 21346355 BACKGROUND

• 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.

  PMID: 18594291 BACKGROUND

• 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.

  PMID: 24916677 BACKGROUND

• Soderling E, Isokangas P, Pienihakkinen K, Tenovuo J. Influence of maternal xylitol consumption on acquisition of mutans streptococci by infants. J Dent Res. 2000 Mar;79(3):882-7. doi: 10.1177/00220345000790031601.

  PMID: 10765964 BACKGROUND

• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

  PMID: 5264376 BACKGROUND

• 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. doi: 10.1111/j.1600-051X.2005.00795.x.

  PMID: 16128840 BACKGROUND

• Wu H, Moser C, Wang HZ, Hoiby 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.

  PMID: 25504208 BACKGROUND

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

  PMID: 24916678 BACKGROUND

• 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. doi: 10.1177/0022034511434354.

  PMID: 22699675 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Dental Caries

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Study Officials

• Pamela Den-Besten, DDS, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind randomized control trial

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: April 29, 2020
• Study Start: February 8, 2019
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)