Acidogenic Potential of Splendaź Quick Pack^TM in Aqueous Solution

Sucralose, a non-fermentable carbohydrate synthesized from sucrose, has been shown to reduce acidogenic potential in dental plaque. Splendaź Quick Pack™ (SQP), a sucralose-based product formulated for use with unsweetened powdered beverages, offers the opportunity for reducing excess sugar intake and caries risk. Objective: The objective of this study was to demonstrate that a solution of SQP in water, at a concentration intended for use in unsweetened beverages, would not promote dental caries [not lower plaque pH <5.7 within 30 minutes (21 CFR Part 101)]. Methods: Healthy adult subjects (n =24) able to form acidogenic plaque (pH drop ≤ 5.7 when challenged with 10% sucrose rinse) were randomized into the double blind, counter-balanced, crossover-designed study. On each test visit subjects rinsed for 60s with one of two investigational products: 1) A solution of 10% sucrose in water, or 2) An iso-sweet solution of SQP in water. Acid production (plaque pH) was measured by touch microelectrode at a minimum of 5 interproximal locations at various time points after rinsing. Results: The mean baseline pH prior to rinsing was 6.70. The mean minimum pH within 30 minutes after rinsing with SQP in aqueous solution was 6.21 ± 0.36 (significantly above pH 5.7, p < 0.0001), compared with 5.34 ± 0.41 after rinsing with sucrose (below pH 5.7). Moreover, as evidenced by the Area Under the Curve (AUC) over 30 minutes, the modest pH drop from SQP rinse returned rapidly back to baseline compared with the sucrose rinse (AUC 4.04 ± 9.09 vs. 28.93 ± 11.81, respectively, p < 0.0001). Conclusion: Splendaź Quick Pack™ in aqueous solution at a concentration intended for regular use with an unsweetened powdered beverage mix does not produce plaque pH below 5.7 and therefore should not promote dental caries. This study was funded by McNeil Nutritionals, L.L.C.