Clinical Effects of Sodium Bicarbonate/Pyrophosphate Dentifrice on Plaque and Gingivitis

Objectives: This clinical study evaluated the effect of a novel sodium bicarbonate/pyrophosphate dentifrice on plaque and gingivitis relative to a negative control over 12 weeks of use.
Methods: This was a single-center, randomized, parallel, examiner-blind, 12-week, controlled clinical trial. Institutional review and informed consent were obtained, and 150 adults with evidence of gingivitis were stratified based on plaque and gingivitis scores, number of bleeding sites, and smoking habit, and randomly assigned to either use a new Sodium Bicarbonate/pyrophosphate (Test) or a regular dentifrice (Control, Blend-a-Med Classic). Subjects brushed teeth twice daily using a soft manual toothbrush. Gingival health was determined using the Modified Gingival Index (MGI) and number of bleeding sites (BS) at Baseline, Week 4, and Week 12. Plaque was assessed using the Turesky Modified Quigley Hein Plaque Index (TQHPI) at Baseline and Week 12. Between-groups comparisons were performed using analysis of covariance.
Results: Subjects’ mean age was 45 years; 64% were female. Overall Baseline means were 1.98 for MGI 59.33 for BS, and 4.27 for TQHPI. The mean MGI was 1.82 at both timepoints for the Test, and 1.87 and 1.88 for the Control group at Week 4 and Week 12, respectively. Mean numbers of BS were 39.5 and 37.1 for the Test group, and 49.1 and 47.8 for the Control group at Week 4 and Week 12, respectively. The Test group showed significantly (p<0.001) greater reduction in MGI and number of BS vs. the Control after 4 and 12 weeks of use. At Week 12, mean TQHPI was 3.92 for the Test and 4.02 for the Control group. The Test group showed significantly (p=0.004) greater TQHPI reduction vs. the Control group after 12 weeks of use.
Conclusions: The novel Gingivitis Treatment dentifrice containing Sodium Bicarbonate and Pyrophosphate provided significant reductions in plaque and gingivitis when compared to a regular dentifrice.