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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01623362
Other study ID # LOWF-UFPB
Secondary ID
Status Completed
Phase Phase 3
First received May 18, 2012
Last updated June 15, 2012
Start date September 2010
Est. completion date February 2012

Study information

Verified date May 2012
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date February 2012
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 4 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Low-fluoride acidic dentifrice
550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
conventional dentifrice
1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
neutral pH and low-fluoride dentifrice
500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months

Locations

Country Name City State
Brazil Paraíba Federal University João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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