NCT02016001

Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.

Detailed description

In developed countries, well-controlled clinical trials have investigated the effective fluoride level in toothpaste and provided irresistible data in relation to the caries controlling efficacy of tooth pastes. But there has been no such data reported in our part of the world. This indicates the need to determine the effective concentration of fluoride in locally manufactured tooth pastes for accomplishment of the goal of prevention against dental caries. This will be a Parallel Group, Double-Blind, Randomized Controlled Trial, over a period of 18 months. The study will be conducted in a randomly selected school of Karachi city. Participants will be the cohort of regular school children aged 12-14 years. Sample size for the present study attained was 330 (165 in both groups), expected attrition rate will be kept as 15%, so the total sample size is 330 + 50 = 380 (190 in each group).

Conditions

• Dental Caries

Interventions

Type	Name	Description
OTHER	toothpaste 1 with maximum fluoride concentration	tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500 ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes
OTHER	toothpaste 2 with 1000 ppm of fluoride	tooth paste 2 will be the intervention with 1000ppm of fluoride, will be used by the control group. They will brush the teeth twice daily for 2 minutes

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-12-19
• Last updated: 2014-08-13

Locations

1 site across 1 country: Pakistan