Efficacy of a Prototype Solution to Facilitate the Removal of Supragingival Dental Calculus: A proof of concept study

Abstract

Purpose: The purpose of this study was to determine whether the adjunctive use of an experimental calculus disruption solution (EXP-955), combined with the exclusive use of hand instruments, decreases the amount of time required to remove supragingival dental calculus deposits.

Methods: A single-site, randomized, split-mouth clinical trial was conducted to compare the time needed to remove supragingival dental calculus on deposits pretreated with an experimental calculus disruption solution vs. calculus deposits that were not pretreated. Quadrants were randomized to either the treatment or control group and the principal investigator (PI) was timed while using hand instruments to remove the calculus. At the end of each session, both the subjects and the PI completed a questionnaire assessing their perceptions regarding the various aspects of the appointment and the solution. Descriptive statistics were used to analyze the data. Recurring themes from the questionnaire were examined.

Results: Twenty-five healthy subjects, each having two quadrants matched for number of teeth and level of calculus deposits, completed the study (n=25). A statistically significant difference was found in in the supragingival calculus removal times between the control, (M=12.5 minutes; SD=6.0), and the treatment, (M=9.7; SD=4.6), quadrants; Mean difference (95% CI) = 2.8 (1.8-3.7), p<0.0001. Thematic analysis of the questionnaire responses showed that the perceptions of the principal investigator and subjects were positive towards the use of the solution with less pain being a common participant comment. The experimental calculus disruption solution was well tolerated by all subjects.

Conclusions: Results from this proof of concept study provide preliminary evidence that use of an experimental calculus disruption solution (EXP-955) reduced the time needed to remove supragingival calculus while using hand instrumentation.