Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children
NCT ID: NCT04368533
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
78 participants
INTERVENTIONAL
2019-02-08
2020-08-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.
9 Months
12 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Pamela Den-Besten, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Pediatric Dentistry Parnassus Clinic
San Francisco, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Young DA, Featherstone JD. Caries management by risk assessment. Community Dent Oral Epidemiol. 2013 Feb;41(1):e53-63. doi: 10.1111/cdoe.12031.
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.
Other Identifiers
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17-22447
Identifier Type: -
Identifier Source: org_study_id
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