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Completed

NCT Number: NCT01049503

Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

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.

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Key information

Conditions

Dental Fluorosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Caries Dental Enamel Hypomineralization Developmental Defects of Enamel Fluorosis, Dental Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Demineralization Tooth Diseases

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Public primary schools in Bauru

Bauru, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fluoride and conventional dentifrices with different pH

Other

Comparison of different dentifrice fluoride concentrations and pH on caries control

Other names: Dentifrice with 550 ppm F (NaF) and neutral pH (7.0), Dentifrice with 550 ppm F (NaF) and acidic pH (4.5), Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0)

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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%.

  5. 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial

Acronym: EPHFCDCC

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 14, 2010
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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