Evaluation of a Low Fluoride Dentifrice for Caries Control

Federal University of Paraíba

Status and phase: Completed; Phase 3

Conditions: Dental Caries

Treatments: Other: neutral pH and low-fluoride dentifrice; Other: Low-fluoride acidic dentifrice; Other: conventional dentifrice

Study type: Interventional

Funder types: Other

Identifiers

NCT01623362

LOWF-UFPB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

212 participants in 3 patient groups

Low-fluoride acidic dentifrice

Experimental group

Treatment:

Other: Low-fluoride acidic dentifrice

Conventional dentifrice

No Intervention group

Description:

1100µgF/g-pH7.0

Treatment:

Other: conventional dentifrice

neutral pH and low-fluoride dentifrice

Experimental group

Description:

550 ppm pH 7

Treatment:

Other: neutral pH and low-fluoride dentifrice