Dental Caries Clinical Trial
— EPHFCDCCOfficial title:
Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial
Verified date | August 2012 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 315 |
Est. completion date | February 2012 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 4 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Public primary schools in Bauru | Bauru | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. | Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). | 6 months | Yes |
Primary | Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. | Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). | 6 months | Yes |
Secondary | Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 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 | Yes |
Secondary | Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 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 | Yes |
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 %)) | 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 | Yes |
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)) | 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 | Yes |
Secondary | Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | 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 | Yes |
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