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A Study Design And Methodology Essay

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Study design and methodology

This study is a non inferiority randomized, double blind, stratified (age group 16-60 years),single site controlled clinical trial to be conducted in the primary dental care, Birmingham ,UK with 1:1 randomization .The study will have two –treatment parallel group to randomly assign patient with dentinal sensitivity into two groups using double blind, randomized design. Novamin containing Sesondyne repair and protect dentifrice will be compared to the gluma desensitizer.
Participants are to be evaluated at baseline ,immediately, after 3,6 and 9 months post application using visual analogue scale for tactile stimuli response and Schiff cold air sensitivity scale for standard cold air blast. Individual tooth is the unit of the study in this trial. 120 patients [450 teeth] including between the age group of 16 and 600 years are to be recruited without any gender bias.
Principal investigator will clinically evaluate all participants to confirm that they have DH and will include eligible subjects in the trial based on the following inclusion and exclusion criteria.

Inclusion criteria were as follows:
1) Patients with the age group 16-60 attending general dental practice
2) Presenting with a complaint of sensitivity only due to cervical abrasions
3) Healthy individuals with no other medical problems.
4) Dentinal hypersensitivity due to cervical abrasions on the both anterior and posterior
5) 3 or more teeth should be affected by cervical
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