- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01049503
Effect of pH and Fluoride Concentration of Dentifrices on Caries Control (EPHFCDCC)
August 20, 2012 updated by: Marilia Afonso Rabelo Buzalaf, University of Sao Paulo
Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial
This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method.
Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Dentifrices have been recognized as one of the contributors in the increased prevalence of dental fluorosis, due to the fact that children in early childhood usually eat lots of them during brushing.
As an alternative to the reduction of fluorosis have been suggested to reduce the concentration of fluoride toothpaste, however, its efficacy is not well established, increasing when the pH of the toothpaste is acidic, with a greater diffusion of F in the enamel.
Therefore, this study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area.
A randomized double-blind study will be conducted with approximately 360 children aged 2 to 4 years old at public daycare centers located in a fluoridated area.
Children will be examined by two examiners and classified according to caries activity.
For 12 months, children will use 3 times a day, one of the toothpaste to be tested, with different concentrations of fluoride and pH.
At the end of this period, children will be examined by the same examiners to check the progression of lesions.
Clinical examinations should be performed by 2 calibrated examiners (kappa 0.8) at baseline and after 12 months.
The diagnostic criteria of caries activity (active, inactive) and integrity of the surface of the lesion will be used.
There will be a quantitative assessment of carious lesions fluorescence with a portable QLF equipment.
In half of the sample, nails and plaque will be collected 6 months after initiation of the dentifrices use.
Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
The presence of nails F will be analyzed as described above.
For statistical analysis will be used ANOVA and test for individual comparisons.
Study Type
Interventional
Enrollment (Actual)
315
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Bauru, São Paulo, Brazil
- Public primary schools in Bauru
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- >= 2 years and <= 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 (if this occurs, the child will be referred for treatment);
- Signature of informed consent by the parents
Exclusion Criteria:
- Using orthodontic appliances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Caries-active 550 ppm F, pH 7.0
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
Active Comparator: Caries-active 550 ppm F, pH 4.5
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
Active Comparator: Caries-active 1100 ppm F, pH 7.0
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
Active Comparator: Caries-inactive 550 ppm F, pH 7.0
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
Active Comparator: Caries-inactive 550 ppm F, pH 4.5
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
Active Comparator: Caries-inactive 1100 ppm F, pH 7.0
This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area.
One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.
|
Comparison of different dentifrice fluoride concentrations and pH on caries control
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.
Time Frame: 6 months
|
Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
|
6 months
|
Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.
Time Frame: 6 months
|
Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
Time Frame: baseline and 12 months
|
The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months.
The net increment was calculated from the difference between lesions' progression and regression.
The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth).
The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.
|
baseline and 12 months
|
Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
Time Frame: baseline and 12 months
|
The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months.
The net increment was calculated from the difference between lesions' progression and regression.
The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth).
The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.
|
baseline and 12 months
|
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))
Time Frame: baseline and 12 months
|
The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children.
The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC.
For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%.
A negative ∆F value indicates caries regression.
|
baseline and 12 months
|
Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))
Time Frame: baseline and 12 months
|
The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children.
The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC.
For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%.
|
baseline and 12 months
|
Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used
Time Frame: baseline and 12 months
|
The lesions' progression was evaluated by the data from the examinations at baseline and after 12 months.
The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).
|
baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marília AR Buzalaf, PhD, Bauru Dental School, University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 13, 2010
First Posted (Estimate)
January 14, 2010
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
August 20, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USP0162009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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