Assume a male adult, which excludes fluorosis development and pregnancy. What are the downsides, if any, of using a toothpaste with a high sodium fluoride concentration (e.g., sodium fluoride 1.1 per cent, 5,000ppm)?

I Googled the question but I couldn't find any downsides supported by scientific evidence. I could only read some potential upsides.

  • 5000 ppm is prescription strength, which means it must be FDA approved and that means there must be clinical trials.
    – Carey Gregory
    Commented May 19 at 18:14

1 Answer 1


Studies {1,2,3} report no side effects.


No reports of side effects due to the toothpaste or the brushing were noted during the study.


No adverse effects of either product were observed during the course of the study.


With respect to saliva sampling, no complaints or side effects were reported by any of the test persons or during any of the toothpaste regimens.


  • {1} Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res. 2013;47(5):391-8. doi: 10.1159/000348581. Epub 2013 Apr 9. PMID: 23594784.
  • {2} Baysan A, Lynch E, Ellwood R, Davies R, Petersson L, Borsboom P. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Caries Res. 2001 Jan-Feb;35(1):41-6. doi: 10.1159/000047429. PMID: 11125195.
  • {3} Ekstrand KR, Ekstrand ML, Lykkeaa J, Bardow A, Twetman S. Whole-Saliva Fluoride Levels and Saturation Indices in 65+ Elderly during Use of Four Different Toothpaste Regimens. Caries Res. 2015;49(5):489-98. doi: 10.1159/000434730. Epub 2015 Aug 6. PMID: 26278523.

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