title: A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.
abstract: BACKGROUND
  In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health.
  
  
  METHODS
  This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events.
  
  
  RESULTS
  Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701).
  
  
  CONCLUSIONS
  This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use.
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: A
authors.initials: A
authors.lastname: Lomax
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: S
authors.initials: S
authors.lastname: Patel
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: N
authors.initials: N
authors.lastname: Wang
authors.affiliation: Global Health Research Group, New Delhi, India.
authors.forename: K
authors.initials: K
authors.lastname: Kakar
authors.affiliation: Global Health Research Group, New Delhi, India.
authors.forename: A
authors.initials: A
authors.lastname: Kakar
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: M L
authors.initials: ML
authors.lastname: Bosma
mesh_terms: D000328:Adult; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D016037:Single-Blind Method; D017693:Sodium Bicarbonate / Q000627:therapeutic use*; D014099:Toothbrushing; D014100:Toothpastes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014100:Toothpastes; D017693:Sodium Bicarbonate
keywords: dentifrice; gingivitis; sodium bicarbonate; toothpaste; volatile sulphur compounds