The effectiveness and safety of fissure sealant as a conservative management of pit and fissure(Non cavitated occlusal) caries compared to standard direct restoration approach: a Split- Mouth Trial

The effectiveness and safety of fissure sealant as a conservative management of pit and fissure(Non cavitated occlusal) caries compared to standard direct restoration approach: a Split- Mouth Trial

Statistical analysis

A data management software package (IBM SPSS Statistics, 2015 version) will be used for data entry and processing .

The data  analysis will be ‘per-protocol’ analysis whereby participants who do not receive the intervention to which they are randomised  or drop out before complete the study are excluded from the analysis.

The primary outcome will be :

– The analysis of Clinical caries progression

 

The Incidence of the primary outcomes will assessed by calculating the relative risk of each outcome and its 95 confidence limits

-The risk ratio is simply a comparison of the risk in the exposed (experimental ) group to the risk in the unexposed(control)group

Risk  in the F.S (intervention) group = =

Risk in the Restoration(Control) group =  =

Risk Ratio(RR)=  = (%)

 

Table . Absolute and relative frequency, relative risk (RR) and confidence interval (CI) of clinical caries progression at the end of the study period.
Group Increase in Clinical Caries Level

(Clinical Caries Progression)

 P RR CI(95%)
NO

n%

 YES

n%
Fissure Sealant(Experimental ) 28 32 % n-n
Composite Restoration(Control) 4 56 % n-n

 

Hypotheses testing :

Null Hypothesis(H0) ; There is no statistically significant difference in the proportion(?ratio) of caries progression in the control group(Composite restoration) and the proportion of caries progression(?Ratio) in the intervention(Resin-Based Fissure Sealant) group.

Alternative hypothesis ; There is a statistically significant difference in the proportion of caries progression (?Ratio) in the control (Composite restoration)group comparing to the proportion (?ratio) of caries progression in the intervention(RBFS) group

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Questions(Instructions)

1- Discuss in details Rejecting or accepting the null hypothesis

2-To analyse your data, you need to suggest the most appropriate test for a statistician to use for testing the hypotheses. The basic methods are: t-tests, chi square tests, correlation and regression.  Include a description of the statistical tests that you are proposing and use dummy tables to demonstrate how the results will be displayed.

 



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