Dental Caries
Conditions
Keywords
Dentifrices, Dental Caries, Fluorides, Nails, pH
Brief summary
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
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.
Interventions
OTHERLow-fluoride acidic dentifrice
550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
OTHERconventional dentifrice
1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
OTHERneutral pH and low-fluoride dentifrice
500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities | 6 months | Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months | 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 |
Countries
Brazil
Outcome results
None listed