Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02592278
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Universidad Iberoamericana

Tracking Information
First Submitted Date  ICMJE October 28, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria) [ Time Frame: One year ]
We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02592278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Official Title  ICMJE Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Brief Summary

The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.

Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Drug: Fluoride Varnish
    Application of fluoride varnish every 3 and 6 months.
    Other Name: Duraphat (Colgate)
  • Drug: Control Group
    Twice a day brush with fluoride toothpaste.
    Other Name: Colgate Total Toothpaste
Study Arms  ICMJE
  • Experimental: Fluoride Varnish each 6 months
    Fluoride Varnish application every 6 months.
    Intervention: Drug: Fluoride Varnish
  • Experimental: Fluoride Varnish each 3 months
    Fluoride Varnish application every 3 months.
    Intervention: Drug: Fluoride Varnish
  • Active Comparator: Fluoride tooth paste
    Control group. Twice a day brush with fluoride toothpaste.
    Intervention: Drug: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2015)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent from parents.
  • Child assent
  • High risk of dental caries
  • At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

  • Bad behaviour
  • Any systemic condition, disability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592278
Other Study ID Numbers  ICMJE 04-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universidad Iberoamericana
Study Sponsor  ICMJE Universidad Iberoamericana
Collaborators  ICMJE Colgate Palmolive
Investigators  ICMJE
Principal Investigator: Ninoska Abreu Universidad Iberoamericana
PRS Account Universidad Iberoamericana
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP