Clinical Significance Versus Statistical Significance with Regards Gingival Scores in Herbal and Chlorhexidine Mouthwash Clinical Trials- A Systematic Review

Purpose: Does clinical significance match with the statistical significance with respect to gingival score when herbal mouthwash is used in comparison to the chlorhexidine mouthwash? Material and Method: A systematic search of literature was conducted on two databases (PubMed and Google Scholar) for the studies published from 1st January 2006 to 31st December 2018. Cross-references were checked. Hand searching was done in the library. Studies were included if they were done among healthy, non hospitalized humans and compared chlorhexidine with herbal mouthwash for the gingivitis score.Clinical significancewas ascertained based on Loe and Sillness (1967) Gingival index interpretation. Results:A total of 22 unique clinical trials were identified and 24estimates which used Gingival index as outcome assessor. 18 estimates showed matching between clinical significance and statistical significance in the chlorhexidine group while in herbal group it was found only in 15 estimates. As per Thirthalli J, Rajkumar RP criteria none of the studies showed clinical significance. Conclusion: Statistical significance does not always mean clinical significance. Researchers should modify their study design to focus on clinical significance along with statistical significance.