12-Week Calculus Clinical: DZA Toothpaste vs. Colgate Fluoride Toothpaste

Objectives: This 12-week calculus clinical study was designed to investigate clinical efficacy in supragingival calculus formation of Dual Zinc with Arginine (DZA) Toothpaste as compared to Colgate Fluoride Toothpaste after 12 weeks of product use. The Volpe-Manhold calculus index was utilized to assess supragingival calculus formation.
Methods: Following baseline examinations of Volpe-Manhold Calculus Index (V-MCL) and soft tissue, qualified subjects entered an 12-week pre-test phase. After receiving an oral evaluation and a prophylaxis, subjects were instructed to brush twice daily (morning and evening) for 1 minute each time. After 12 weeks, subjects received a baseline supragingival calculus examination via V-MCI. After receiving an oral evaluation and a prophylaxis, subjects were randomized into two groups (Test and Negative Control), which were balanced for Volpe-Manhold Calculus Index. All subjects were provided with their assigned toothpaste and were instructed to brush as described previously. Examinations of Volpe-Manhold Calculus Index scores were conducted again after twelve weeks of product use.
Results: After the clinical protocol was approved by an IRB, one hundred fifty (150) subjects entered the clinical study, and one thirty nine (139) subjects complied with the protocol and completed the 12-week study. At the 12-week examination, the Test Group subjects presented a mean Volpe-Manhold index=6.07 and the Control Group=9.87. Subjects in the Test Group exhibited statistically significant more supragingival calculus reduction (38.5%) compared to subjects in the Control Group.
Conclusions: The clinical study supported that the toothpaste containing DZA and 0.145% sodium fluoride provides significantly greater reductions in supragingival calculus as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate at 12 weeks.