Clinical Trial: Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:

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).

Sponsor: Dow University of Health Sciences

Current Primary Outcome: changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months. [ Time Frame: 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Dow University of Health Sciences

Dates:
Date Received: November 9, 2013
Date Started: April 2013
Date Completion: October 2014
Last Updated: August 11, 2014
Last Verified: August 2014