Dental Caries Clinical Trial
Official title:
Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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