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Cited by 4Oral microbiology and periodontitis researchDental Health and Care UtilizationDental Erosion and Treatment

Better living through chemistry? A randomized, double-blind controlled study evaluating the efficacy of plaque control and gingival health impacts of a novel stannous fluoride-containing gel

Open access
Takesh, Thair, Goshtasbi, Arezou, Lin, Kairong, Yang, Susan Meishan, Wink, Cherie, Geisinger, Maria L., Wilder‐Smith, Petra·2023·Journal of Periodontology
DOI 10.1002/jper.22-0254PMC PMC10569749
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Abstract

BACKGROUND: Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices are necessary to reverse gingivitis and a dentifrice that could provide significant clinical reductions in plaque accumulation and gingival inflammation would be desirable to treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a novel stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra-acetic acid (EDTA) as an antitartar agent to reduce Plaque Index (PI) and Gingival Index over a 3-month study period. METHODS: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using either a novel dental gel containing 0.454% stannous fluoride and 2.6% EDTA or a dentifrice with 0.24% sodium fluoride. Sixty subjects participated over a 3-month period. Co-primary endpoints were improvements in PI and Modified Gingival Index (mGI) from baseline values. No professional cleaning was performed during the study period. RESULTS: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using the novel dental gel showed statistically significantly greater reductions in PI (ΔPI) [(-1.43 ± 0.34; -0.49 ± 0.13) (p < 0.00001)], mGI (ΔmGI) [(-1.11 ± 0.22; -0.16 ± 0.12) (p < 0.00001)], and modified sulcular bleeding index (ΔmSBI) [(-1.15 ± 0.18; -0.20 ± 0.07) (p < 0.00001)]. CONCLUSIONS: The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.

Integrity signals

Registry

Crossref · 10.1002/jper.22-0254

Cites

52 of 52 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

18 of 41 cited sources checked · 7 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Preventing destructive periodontal disease depends on disrupting dysbiotic biofilm and lowering gingival inflammation.

    “The primary prevention of destructive periodontal diseases requires the removal and disruption of dysbiotic biofilm and the subsequent reduction in gingival inflammation seen in patients with gingivitis.47”
    Quote in the paperSubstantial claim1 of 1 sources checked
  • Premisecitation

    Prior investigations of 2.6% EDTA dentifrice lacked fluoride in the formulation.

    “These previous investigations of 2.6% EDTA containing dentifrice lacked the inclusion of fluoride in the formulation.”
    Quote in the paperSubstantial claim4 of 6 sources checked
    • cites [22] source

      The Introduction identifies the tested dentifrice as containing 2.6% activated edathamil, and the Clinical Protocol identifies it as Livionex Dental Gel. Our copy does not say whether that formulation contained fluoride, so it does not support the claim that fluoride was absent. (LLM, conf=0.78)

      Experimental — accuracy not yet measured
    • cites [23] source

      The Introduction (page unavailable) identifies the studied dental gel as containing 2.6% activated edathamil, and the Clinical Protocol identifies it as the test dentifrice. Our copy does not state that fluoride was absent from its formulation; naming edathamil and MSM does not establish a complete ingredient list. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [24]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [25] source
    • cites [26] source

      The Introduction and Discussion state that this study’s test dental gel contained no fluoride and identify activated edathamil as an ingredient. Our copy does not establish that the gel contained 2.6% EDTA or that multiple prior investigations used that formulation. (LLM, conf=0.82)

      Experimental — accuracy not yet measured
    • cites [27]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Premisecitation

    Although most patients say they brush twice daily, reported daily interdental cleaning varies from 1.5% to 37%.

    “Furthermore, while most patients report that they brush twice daily, the reporting of daily interdental cleaning ranges between 1.5% and 37%.50,51”
    Quote in the paperSubstantial claim2 of 2 sources checked
    • cites [50] source

      The Discussion reports daily flossing by 37% of women aged 30 and older, supporting the upper figure for that subgroup. The Results assign 1.5% to flossing six days a week, not daily; the Methods define daily as seven days. The paper does not report how many people brush twice daily. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [51] source

      The Results and Table 1 report flossing in weekly frequency categories, including 35% who flossed no more than once and 40% who flossed at least five days a week. Our copy does not give a 1.5%–37% range for daily interdental cleaning or say that most patients brush twice daily (searched for the range, daily cleaning, and twice-daily brushing). (LLM, conf=0.75)

      Experimental — accuracy not yet measured
  • Premisecitation

    Prior work has established that stannous fluoride has better antiplaque and antigingivitis effects than sodium fluoride.

    “It has been well-established that stannous fluoride demonstrates superior antiplaque and antigingivitis qualities when compared to sodium fluoride.54–56”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [54] source

      The Results (page unavailable in our copy) report less gingival bleeding with stannous-fluoride dentifrice than with negative controls that included sodium fluoride. The paper does not establish superior antiplaque effects versus sodium fluoride; its meta-analysis assesses gingival bleeding, and its negative-control group combines sodium fluoride with sodium monofluorophosphate. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [55] source
    • cites [56] source
  • Interpretationcitation

    Because the study did not try to change other oral hygiene habits, its use of the new dentifrice likely reflected real-world conditions.

    “This study also did not seek to alter other oral hygiene practices, which likely led to a more real-world implementation of novel dentifrice use that better approximates the behavior patterns of patients, who may be unlikely to substantively change oral home care routines in the long term without ongoing intensive interventions.52,53”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [52] source

      The Discussion (page unavailable) says interventions addressing a range of barriers may help oral-health behaviours persist longer, which supports the general point that sustained change can require more than a simple intervention. It does not establish that patients are unlikely to change their home-care routines long term without ongoing intensive interventions. The statement about the dentifrice study's design is the citing authors' own description, not a finding attributed to this review. (LLM, conf=0.78)

      Experimental — accuracy not yet measured
    • cites [53] source
  • May combine two claims. 16
  • Classified as probably not a substantial claim. 11
  • The quote only partly states this claim. 1

  • May combine two claims.

    Premisecitation

    Gingivitis is an inflammatory response to oral biofilm accumulation and is almost always a necessary precursor to periodontitis.

    “Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis.”
    • Also stated in: § DISCUSSION · boosted
      “It is well-established that gingivitis is, in almost all cases, a necessary precursor to periodontitis.47”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • May combine two claims.

    Premisecitation

    Stannous fluoride has direct antimicrobial properties and provides fluoride ions to form fluorapatite after acidic demineralization.

    “Stannous fluoride has also demonstrated direct antimicrobial properties as well as providing available fluoride ions to form fluorapatite after acidic demineralization of tooth hard tissues.43,44”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [43] source

      The Discussion states that the stannous ion provides SnF₂’s antimicrobial effect. Our copy does not describe fluoride ions forming fluorapatite after acidic demineralization, so it does not support that part of the claim. (LLM, conf=0.89)

      Experimental — accuracy not yet measured
    • cites [44]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    Previous studies showed that a 2.6% EDTA dental gel reduces plaque, gingival inflammation, and probing depths with minimal side effects.

    “Previous studies have demonstrated the efficacy of a dental gel with 2.6% ethylenediamine tetra-acetic acid (EDTA) as an antitartar agent in reducing oral plaque deposit, gingival inflammation, and probing depths with minimal patient-reported side effects or impact upon tooth surface microarchitecture and microhardness.22–27”
    Quote in the paperSubstantial claim2 of 6 sources checked
    • cites [22]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [23] source

      The Introduction identifies the test gel as a 2.6% activated-edathamil formulation, and Clinical Data reports reduced plaque and gingival indices after 21 days. The Clinical Protocol says probing depth was measured, but the reported results do not show a reduction; the paper also does not report patient-reported side effects, tooth microhardness, or an antitartar outcome. Imaging showed an unaltered pellicle, which is narrower than a claim about tooth-surface microarchitecture. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [24]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [25] source
    • cites [26]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [27]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    Interdental cleaning done regularly is linked to lower plaque scores and less gingival inflammation.

    “Such lower levels of reporting for inderdental cleaning persist despite recommendations from the ADA and other organized dental groups based upon the fact that regular interdental cleaning has been associated with reduced plaque indices and clinical gingival inflammation.50,51”
    Quote in the paperSubstantial claim2 of 2 sources checked
    • cites [50] source
      Experimental — accuracy not yet measured
    • cites [51] source
      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Participants were 19-33 years old (mean 22.5 years); 47% were female and 53% male.

    “Study participants ranged from 19 to 33 years old with a mean age of 22.5 years. The study population was 47% female and 53% male.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The test dentifrice produced a 46% reduction in mean whole-mouth Modified Sulcular Bleeding Index versus 7.5% for the control, a statistically significant difference.

    “Overall reductions in mean whole-mouth PI, mGI, and mSBI were 55.5%, 44.7%, and 46% for the test dentifrice and 20.8%, 5.9%, and 7.5% for the positive control dentifrice (Figure 2). These differences were statistically significantly different for all indices.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The test dentifrice produced a 55.5% reduction in mean whole-mouth Plaque Index versus 20.8% for the control, a statistically significant difference.

    “Overall reductions in mean whole-mouth PI, mGI, and mSBI were 55.5%, 44.7%, and 46% for the test dentifrice and 20.8%, 5.9%, and 7.5% for the positive control dentifrice (Figure 2). These differences were statistically significantly different for all indices.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The test dentifrice produced a 44.7% reduction in mean whole-mouth Modified Gingival Index versus 5.9% for the control, a statistically significant difference.

    “Overall reductions in mean whole-mouth PI, mGI, and mSBI were 55.5%, 44.7%, and 46% for the test dentifrice and 20.8%, 5.9%, and 7.5% for the positive control dentifrice (Figure 2). These differences were statistically significantly different for all indices.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Stannous fluoride in a dentifrice has antiplaque and antigingivitis effects.

    “Data also suggest that the use of stannous fluoride in a dentifrice has an antiplaque and antigingivitis effect for patients with gingival inflammation.34–36”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [34]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [35] source
    • cites [36] source

  • May combine two claims.

    Premisecitation

    When oral hygiene stops, any person can develop gingivitis; in those without attachment loss, careful oral hygiene can restore gingival health.

    “Previous investigations have demonstrated that all individuals are susceptible to develop gingivitis if oral hygiene measures are ceased and that, in patients without established periodontal attachment loss, meticulous oral hygiene can re-establish gingival health.48,49”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [48] source
    • cites [49] source

  • May combine two claims.

    Premiseown data

    EDTA reduces plaque and gingivitis by reducing zeta potential on hydroxyapatite, increasing electrostatic repulsion between tooth surface and bacteria.

    “The mechanism of action of EDTA in plaque and gingivitis reduction has been identified as a reduction in the zeta potential (a measure of electrical charge) on hydroxyapatite spheres more negative, which then resulted in an increased repulsive force between the tooth surface and negatively charged bacteria (unpublished data, available upon request).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites unpublished data

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [27]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [42] source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Every enrolled subject reported finishing the study and following the protocol fully.

    “All enrolled subjects reported completion of the study in full compliance with the protocol during all telephone contacts and in-person dental visits.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study was approved by the University Institutional Review Board.

    “approved by the University Institutional Review Board (IRB) (Protocol #2013–9778, #2002–2805, and #881)”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Interpretationown data

    The new gel led to significantly larger improvements in gingivitis-related clinical measures than the sodium fluoride dentifrice.

    “The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.”
    • Also stated in: § CONCLUSION · boosted
      “The results of this clinical study demonstrate that the use of a novel dentifrice with 0.454% stannous fluoride resulted in clinically and statistically significant improvements in whole-mouth plaque levels and signs of gingival inflammation when compared to a 0.24% sodium fluoride control dentifrice.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The protocol and design were not substantially changed after the study began.

    “No substantial changes were made to the protocol and/or study design after the commencement of the study.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study was registered at ClinicalTrials.gov (#NCT02271815).

    “registered at ClinicalTrials.gov (#NCT02271815).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Participants began with high plaque and gingival inflammation, suggesting poor baseline oral hygiene and elevated risk for plaque-related disease.

    “Furthermore, the individuals included in this study had a high baseline levels of plaque and gingival inflammation, indicating that they had suboptimal baseline levels of oral hygiene and were at high risk for the development of dental plaque-related dental diseases, including caries and periodontal diseases.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    Including a control dentifrice made it possible to assess whether the new dentifrice was more effective than common formulations.

    “Additionally, the use of a control dentifrice allows for an assessment of the improved efficacy of the novel test dentifrice as compared to commonly used formulations.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductreasoning

    Sample size calculations based on prior studies indicated 15 per group (total 30) were needed; 30 per group (total 60) were enrolled to meet ADA Seal requirements.

    “Using a significance level (alpha) of 0.05 (5%) and a Power (1-beta) of 0.8 (80%), the necessary sample size required is 15 per group or a total size of 30. For an abundance of caution, and in order to meet ADA Seal of Acceptance requirements, the study enrolled 30 subjects per group, or a total size of 60 subjects, randomized in a 1:1 ratio.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    The trial was designed as a superiority study against a standard fluoride toothpaste.

    “This was a superiority study using a standard fluoride toothpaste control (commercially available aim multibenefit cavity protection gel toothpaste with sodium fluoride).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Participants and the examiner remained blinded to group assignment for the whole study.

    “Both study participants and examiner were blinded to randomization throughout the study duration.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Calibration of clinical measurements occurs every quarter and requires at least 90% accuracy.

    “Clinical measurement calibration takes place on a quarterly basis with a minimum of 90% accuracy.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    A computer-generated block randomization assigned participants 1:1 to groups.

    “participants were randomly assigned by a computer-generated block randomization in a 1:1 ratio to receive either the test or control dentifrice.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    Compliance was confirmed with once-weekly telephone contact and by weighing returned dentifrice tubes at monthly visits.

    “Compliance was confirmed with once-weekly telephone contact. Subjects were required to return used dentifrice tubes at monthly visits and tubes were weighed to measure compliance.”
    Quote in the paperSubstantial claim
24 of 24

  • The paper relies on this without support.

    Prior to this study, no study had evaluated a dentifrice containing both stannous fluoride and 2.6% EDTA.

    “this is the first study of which the authors are aware evaluating the use of a dentifrice containing both stannous fluoride and 2.6% EDTA as a tartar control agent.”
    “The clinical impact of the addition of stannous fluoride to this novel dental gel was unknown prior to this investigation.”
1 of 1

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • mSBI baseline control value is off by two orders of magnitude

    Major

    The text reports the control group's baseline modified sulcular bleeding index as 269, which is incompatible with the rest of the passage and with the stated mean change. Given the reported values, this appears to be a missing decimal point or transcription error.

    Reported 269 · recomputed -0.2

  • Claim of unchanged oral hygiene practices conflicts with study instructions

    Minor

    The discussion says the study did not seek to change other oral hygiene practices, but participants were instructed to stop using interproximal cleaning devices during the study.

2 of 2

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Lam T, 2016, Effects of a novel dental gel on enamel surface recovery from acid challenge, Dentistry (Loma Linda), 6, 397
  2. Anbarani AG, 2017, A double‐blinded, randomized study evaluating the in vivo effects of a novel dental gel on enamel surface microstructure and microhardness, J Clin Dent, 28, 49
  3. dos Santos AP, 1995, Database of Abstracts of Reviews of Effects (DARE): Quality‐assessed Reviews

Cited by

Sorted by citations

Related

Authors
Takesh, T., Goshtasbi, A., Lin, K., Yang, S. M., Wink, C., Geisinger, M. L., & Wilder‐Smith, P.
Affiliations
  • University of California, Irvine (US)
  • Concorde College of Dental Hygiene Garden Grove California USA
  • University of Alabama at Birmingham (US)
  • Beckman Laser Institute, University of California Irvine California USA
Corresponding author
Geisinger, Maria L.
ORCID
Venue
Journal of Periodontology
Publisher
Wiley
Published
2022-11-22
Volume
94
Issue
4
Pages
509-518
ISSN
  • 0022-3492 (ISSN-L)
  • 1943-3670
DOI
10.1002/jper.22-0254
PMC
PMC10569749
OpenAlex
W4293827469
Semantic Scholar
5972413d62d4b122ba74c0a5c3fbe7645366f958
Cited by
4
References
52
Citations by year
2026: 1 · 2025: 1 · 2023: 2
FWCI
0.75
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Periodontology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Air Force Office of Scientific Research (FA95501‐17‐1‐0193, FA9550‐20‐1‐0052)
  • University of Arizona
Topics
  • Health Sciences › Dentistry › Periodontics › Oral microbiology and periodontitis research
  • Health Sciences › Dentistry › Periodontics › Dental Health and Care Utilization
  • Health Sciences › Dentistry › Orthodontics › Dental Erosion and Treatment
Keywords
stannous fluoride, dental gel, EDTA, gingivitis, dental plaque, sodium fluoride dentifrice, oral hygiene, periodontitis prevention
MeSH terms
Dental Plaque, Dental Plaque Index, Dentifrices, Double-Blind Method, Edetic Acid, Gingivitis, Humans, Inflammation, Sodium Fluoride, Tin Fluorides

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-09-28.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-09-28.

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