Phase 3
N=315
Effect of pH and Fluoride Concentration of Dentifrices on Caries Control
Dental Fluorosis · Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01049503 ↗Enrolled (actual)
315
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. — 0.80; 1.32; 1.74 mmol/kg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low fluoride and conventional dentifrices with different pH (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. |
0.80; 1.32; 1.74 | <0.05 sig |
| PRIMARY Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. |
1.73; 1.80; 2.56 | <0.05 sig |
| SECONDARY Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used |
2.12; 0.97; 1.75 | <0.05 sig |
| SECONDARY Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used |
1.34; 1.44; 1.84 | <0.05 sig |
| SECONDARY 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 %)) |
2.66; -3.46; -2.72 | <0.05 sig |
| SECONDARY 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)) |
-1.03; 0.13; -0.06 | <0.05 sig |
| SECONDARY Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used |
0.14; 0.03; 0.10 | <0.05 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01049503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.