Efficacy of a Revised Prototype Solution to Facilitate the Removal of Dental Calculus: A follow-up proof-of-concept study.

Purpose The purpose of this follow-up proof-of-concept study was to determine the efficacy of a revised calculus disruption solution in facilitating the removal of both supragingival and subgingival calculus in-vivo, as measured by time, difficulty, and pressure required to remove supragingival and subgingival calculus.Methods Patients from a dental school in Minnesota were recruited to participate in a randomized, split-mouth, cross sectional proof-of-concept study comparing time, difficulty and pressure used with hand instrumentation alone compared to the use of a calculus disruption solution and hand instrumentation. Quadrants were randomized to either treatment or control group. Descriptive and inferential statistics were used to analyze the amount of time used. A paired Student's t-test was used to analyze the primary outcome (α = 0.05). Post-treatment questionnaires were completed by the investigator and participants to score the perceived difficulty and pressure required to remove calculus.Results Thirty participants completed the study. An average of 3.1 minutes less time was needed to remove supra and subgingival calculus in the treatment quadrants although this was not statistically significant (p=0.5757). The secondary outcomes, the investigator and participants' perceived difficulty and pressure used for calculus removal showed either no difference, or slight improvements in the treatment quadrants. Overall, the product was well tolerated by participants.Conclusion Quadrants treated with a calculus disruption solution, required slightly less time than control quadrants for calculus removal with hand instruments although the difference was not statistically significant. Reformulation to increase the viscosity of the solution may improve efficacy. Future studies should include a larger sample size, using multiple operators, and a double-blind study design.