Evaluation of a Low Fluoride Dentifrice for Caries Control

Sponsor

Federal University of Paraíba (Other)

Overall Status

Completed

CT.gov ID

NCT01623362

Collaborator

(none)

212

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Low-fluoride acidic dentifrice Other: conventional dentifrice Other: neutral pH and low-fluoride dentifrice	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Low-fluoride acidic dentifrice

Other: Low-fluoride acidic dentifrice

550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.

Other Names:

No Intervention: Conventional dentifrice

1100µgF/g-pH7.0

Other: conventional dentifrice

1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months

Other Names:

Experimental: neutral pH and low-fluoride dentifrice

550 ppm pH 7

Other: neutral pH and low-fluoride dentifrice

500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months

Other Names:

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts 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.