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J Clin Dent. 2018 Mar;29(1):33-39.

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

Author information

1
GSK Consumer Healthcare, Weybridge, Surrey, UK.
2
Salus Research, Fort Wayne, IN, USA.
3
Syneos Health, Thomas House, Maidenhead, Berkshire, UK.

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.

KEYWORDS:

dental plaque; gingival bleeding; gingivitis; opportunistic micro-organisms; sodium bicarbonate; toothpaste

PMID:
29758155

Conflict of interest statement

Dr. A. Jose and Dr. J. Pratten are employees of GSKCH; Dr. ML Bosma was an employee GSKCH at the time the study was performed. Dr. N. Wang is an employee of Syneos Health, which has received funding from GSKCH. Dr. J. Milleman and Ms. K. Milleman are directors of Salus Research, which has received funding from GSKCH. This study was funded by GSK Consumer Healthcare.

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