Evaluation of a Low Fluoride Dentifrice for Caries Control
Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
1 other identifier
interventional
212
1 country
1
Brief Summary
The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedJune 20, 2012
May 1, 2012
10 months
May 18, 2012
June 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)
6 months
Secondary Outcomes (1)
New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities
12 months
Study Arms (3)
Low-fluoride acidic dentifrice
EXPERIMENTALConventional dentifrice
NO INTERVENTION1100µgF/g-pH7.0
neutral pH and low-fluoride dentifrice
EXPERIMENTAL550 ppm pH 7
Interventions
550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
Eligibility Criteria
You may qualify if:
- Age 2 to 4 years;
- Not having participated in any other clinical study within 3 months prior to selection;
- Not having very large carious lesions or dentin sensitivity during the study;
- Signature of informed consent by the parents.
You may not qualify if:
- Using orthodontic appliances
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paraíba Federal University
João Pessoa, Paraíba, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fábio Sampaio, PhD
Paraíba Federal University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 18, 2012
First Posted
June 20, 2012
Study Start
September 1, 2010
Primary Completion
July 1, 2011
Study Completion
February 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-05