Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial.

Abstract

OBJECTIVES:

Short-term use of sodium bicarbonate (NaHCO3)-containing toothpaste reduces plaque and improves clinical measures of gingivitis. To examine this over a longer period, we compared efficacy and tolerability of twice-daily brushing for 24 weeks with 67% or 0% NaHCO3-containing toothpastes in USA-based participants with moderate gingivitis (Clinicaltrials.gov:NCT02207400).

METHODS:

This was a six-month, randomized, examiner-blind, parallel-group, clinical trial. Investigators randomized adults with blood in expectorate after brushing and ≥ 20 gingival bleeding sites to 67% NaHCO3 (n = 123; n = 107 completed study) or 0% NaHCO3 (n = 123; n = 109 completed study) toothpastes. Primary efficacy variables included between-treatment differences in number of bleeding sites and Modified Gingival Index (MGI) score at 24 weeks. Secondary efficacy variables included Bleeding Index and Turesky modification of the Quigley-Hein Plaque Index (overall and interproximal sites) at six, 12, and 24 weeks. A subset of 50 participants underwent sampling to assess plaque microbiology over the course of treatment.

RESULTS:

Compared with the 0% NaHCO3 toothpaste, the 67% NaHCO3 toothpaste produced statistically significant improvements at Week 24 in number of bleeding sites (46.7% difference) and MGI (33.9% difference), and for all other endpoints (all p < 0.0001). There was no significant between-treatment difference in the proportion of participants harboring opportunistic pathogens. Products were generally well tolerated, with two and five treatment-related adverse events reported in the 67% and 0% NaHCO3 toothpaste groups, respectively.

CONCLUSIONS:

Gingival bleeding, gingivitis, and plaque indices were significantly improved at six, 12, and 24 weeks with twice-daily brushing with 67% NaHCO3-containing toothpaste in participants with moderate gingivitis.

• Authors: Anto Jose, Jonathan Pratten, Mary-Lynn Bosma, Kimberly R Milleman, Jeffery L Milleman, Nan Wang
• Journal: The Journal of clinical dentistry (J Clin Dent) Vol. 29 Issue 1 Pg. 33-39 (Mar 2018) ISSN: 0895-8831 [Print] United States
• PMID: 29758155 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright© by the YES Group, Inc.

Chemical References

• Toothpastes
• Sodium Bicarbonate

Topics

• Adult
• Dental Plaque (therapy)
• Dental Plaque Index
• Double-Blind Method
• Gingivitis (therapy)
• Humans
• Periodontal Index
• Sodium Bicarbonate
• Toothpastes (therapeutic use)
• Treatment Outcome