Clinical Trials Logo
  1. Home
  2. Dental Caries
  3. NCT01049503

Effect of pH and Fluoride Concentration of Dentifrices on Caries Control — EPHFCDCC  

Dental Caries Clinical Trial

Official title:
Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial

Clinical Trial Summary

This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.

Clinical Trial Description

Dentifrices have been recognized as one of the contributors in the increased prevalence of dental fluorosis, due to the fact that children in early childhood usually eat lots of them during brushing. As an alternative to the reduction of fluorosis have been suggested to reduce the concentration of fluoride toothpaste, however, its efficacy is not well established, increasing when the pH of the toothpaste is acidic, with a greater diffusion of F in the enamel. Therefore, this study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area. A randomized double-blind study will be conducted with approximately 360 children aged 2 to 4 years old at public daycare centers located in a fluoridated area. Children will be examined by two examiners and classified according to caries activity. For 12 months, children will use 3 times a day, one of the toothpaste to be tested, with different concentrations of fluoride and pH. At the end of this period, children will be examined by the same examiners to check the progression of lesions. Clinical examinations should be performed by 2 calibrated examiners (kappa 0.8) at baseline and after 12 months. The diagnostic criteria of caries activity (active, inactive) and integrity of the surface of the lesion will be used. There will be a quantitative assessment of carious lesions fluorescence with a portable QLF equipment. In half of the sample, nails and plaque will be collected 6 months after initiation of the dentifrices use. Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). The presence of nails F will be analyzed as described above. For statistical analysis will be used ANOVA and test for individual comparisons. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01049503
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Phase 3
Start date November 2009
Completion date February 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT04127929 - Investigation of Glass Carbomer Performance N/A
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Active, not recruiting NCT04475679 - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy N/A
Completed NCT05438381 - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars N/A
Not yet recruiting NCT03037814 - Clinical Performance of Restorative Materials in Primary Teeth N/A
Active, not recruiting NCT05202665 - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion N/A
Terminated NCT01147835 - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers N/A
Not yet recruiting NCT04033263 - Maintaining Oral Health With Bio-products N/A
Enrolling by invitation NCT04438252 - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions N/A
Not yet recruiting NCT03609034 - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02473107 - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth N/A
Active, not recruiting NCT02537184 - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children N/A
Completed NCT01950546 - Nanosilver Fluoride to Prevent Dental Biofilms Growth Phase 1
Recruiting NCT02734420 - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial Phase 1
Completed NCT02020681 - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions N/A
Completed NCT02426619 - Arresting Active Dental Caries in Preschool Children by Topical Fluorides Phase 2/Phase 3
Completed NCT02234609 - Effectiveness of Modified Class IV Atraumatic Restorative Treatment N/A
Completed NCT01623362 - Evaluation of a Low Fluoride Dentifrice for Caries Control Phase 3