Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Medellín City
|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: NCT00475618|
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 31, 2012
The propouse of this study is to evaluate some combined preventive measures, of easy application in children under 6 years old as education, brush teeth, fluoride free tooth paste,fluoridated tooth paste, professional cleaning and fluoride varnish application, to determine between three groups of differents combined preventive measures, wich one is better in reduting dental caries appearance.
- Ho: Dental caries reduction percentage is larger or equal in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.
- Ha: Dental caries reduction percentage is less in the group with only prevention education and Professional cleaning, than in the groups intercepted with fluoride varnish or fluoride toothpaste.
|Condition or disease||Intervention/treatment||Phase|
|Dental Decay||Procedure: topical fluoride varnish application. Procedure: professional cleaning Procedure: No fluoride toothpaste||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Fluoride Varnish
Professional cleaning + education + fluoride vanish
Procedure: topical fluoride varnish application.
Vanish application every 6 months in all accesible tooth surfaces
Active Comparator: Fluoride Toothpaste 500 ppm
Professional cleaning + education + fluoride toothpaste 500 ppm
Procedure: professional cleaning
Daily use fluoride toothpaste 500 ppm.
Active Comparator: No fluoride toothpaste
Professional cleaning + education + no fluoride toothpaste
Procedure: No fluoride toothpaste
Daily use no fluoride toothpaste.
- Dental Caries reduction as if the patient has or not new dental caries. [ Time Frame: Three years with clinical examination every one year. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475618
|Principal Investigator:||Alexandra Saldarriaga, Master of Sience||CES University - Medellín - Colombia|