Evaluation of a Low Fluoride Dentifrice for Caries Control

Study Overview
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Brief Summary
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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.

Detailed Description
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The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.

Official Title
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Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Low-fluoride acidic dentifrice
* Other: conventional dentifrice
* Other: neutral pH and low-fluoride dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Using orthodontic appliances

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-fluoride acidic dentifrice<br> | Other: Low-fluoride acidic dentifrice<br>* 550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.<br>* Other names: G1;|
| No Intervention: Conventional dentifrice<br>1100µgF/g-pH7.0 | Other: conventional dentifrice<br>* 1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months<br>* Other names: G2;|
| Experimental: neutral pH and low-fluoride dentifrice<br>550 ppm pH 7 | Other: neutral pH and low-fluoride dentifrice<br>* 500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months<br>* Other names: G3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The caries progression/regression of active noncavited and progression of inactive noncavitated was evaluated by the date from the examinations at baseline and after 12 months using Nyvad, Machiulskienec, Baelum,1999: Score 0: Sound/ Score 1: Active caries (intact surface)/Score 2: Active caries (surface discontinuity)/Score 3: Active caries (cavity)/Score 4: Inactive caries(intact surface) /Score 5: Inactive caries (surface discontinuity) /Score 6: Inactive caries(cavity)/Score 7: Filling (sound surface)/Score 8: Filling + active caries/Score 9: Filling + inactive caries | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentifrices, Dental Caries, Fluorides, Nails, pH