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Evaluation of a Low Fluoride Dentifrice for Caries Control

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Low-fluoride acidic dentifrice
conventional dentifrice
neutral pH and low-fluoride dentifrice
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Dentifrices, Dental Caries, Fluorides, Nails, pH

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts 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

Sites / Locations

  • Paraíba Federal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Low-fluoride acidic dentifrice

Conventional dentifrice

neutral pH and low-fluoride dentifrice

Arm Description

1100µgF/g-pH7.0

550 ppm pH 7

Outcomes

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
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
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

Full Information

First Posted
May 18, 2012
Last Updated
June 15, 2012
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT01623362
Brief Title
Evaluation of a Low Fluoride Dentifrice for Caries Control
Official Title
Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dentifrices, Dental Caries, Fluorides, Nails, pH

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-fluoride acidic dentifrice
Arm Type
Experimental
Arm Title
Conventional dentifrice
Arm Type
No Intervention
Arm Description
1100µgF/g-pH7.0
Arm Title
neutral pH and low-fluoride dentifrice
Arm Type
Experimental
Arm Description
550 ppm pH 7
Intervention Type
Other
Intervention Name(s)
Low-fluoride acidic dentifrice
Other Intervention Name(s)
G1
Intervention Description
550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
Intervention Type
Other
Intervention Name(s)
conventional dentifrice
Other Intervention Name(s)
G2
Intervention Description
1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
Intervention Type
Other
Intervention Name(s)
neutral pH and low-fluoride dentifrice
Other Intervention Name(s)
G3
Intervention Description
500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
Primary Outcome Measure Information:
Title
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
Description
Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio Sampaio, PhD
Organizational Affiliation
Paraíba Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paraíba Federal University
City
João Pessoa
State/Province
Paraíba
Country
Brazil

12. IPD Sharing Statement

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Evaluation of a Low Fluoride Dentifrice for Caries Control

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