Cited by 11Oral microbiology and periodontitis researchDental Health and Care UtilizationDental Erosion and Treatment

Evaluating efficacy of a novel dentifrice in reducing probing depths in Stage I and II periodontitis maintenance patients: A randomized, double-blind, positive controlled clinical trial

Open access
Kaur, Maninder, Geurs, Nicolaas C., Cobb, Charles M., Otomo‐Corgel, Joan, Takesh, Thair, Lee, June H., Lam, Tracie M., Lin, Kairong +3 more·2021·Journal of Periodontology

Abstract

BACKGROUND: Compliance to periodontal maintenance therapy (PMT) is essential for long-term periodontal health. Between PMT visits, patients must maintain good oral hygiene. A dentifrice with demonstrable clinical benefits for use between PMT visits would be highly desirable. The aim of this clinical study was to investigate the effect of a novel dental gel on probing depths (PD) and inflammation when used as a home care dentifrice in Stage I and II periodontitis patients. METHODS: This double-blind clinical study randomized 65 subjects with Stage I and II periodontitis to the novel dental gel containing 2.6% EDTA, and a commercially available anti-gingivitis dentifrice with 0.454% stannous fluoride. Primary endpoint was PD at 6 months for those sites with baseline PD ≥ 4 mm and secondary endpoints included whole mouth mean scores of modified gingival index (MGI), modified sulcus bleeding index (mSBI) and plaque index (PI). No SRP was performed at baseline. RESULTS: Subjects using the novel dentifrice showed significant PD reductions of 1.18 mm (from 4.27 mm at baseline to 3.09 mm at 6 months) compared to 0.93 mm (from 4.23 mm at baseline to 3.30 mm at 6 months) shown for those using the positive control dentifrice. Difference between treatments at 6 months was 0.21 mm with P-value = 0.0126. Significant improvements in MGI (P = 0.0000), mSBI (P = 0.0000), and PI (P = 0.0102) were also observed in 6 months. CONCLUSION: The novel dentifrice showed significant reductions in PD and gingival inflammation over 6 months solely as a home care dentifrice without baseline SRP in Stage I and II periodontitis maintenance patients.

Integrity signals

Registry

Crossref · 10.1002/jper.20-0721

Cites

39 of 39 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

9 of 20 cited sources checked · 2 supported · 1 flagged · accuracy not yet measured

  • Premisecitation

    A comprehensive systematic review found that scaling and root planing has a weighted average probing depth reduction of 1.40 mm for sites with baseline probing depth of 4 to 6 mm.

    “A comprehensive systemic review article found the PD reductions for the SRP (which is the gold standard for nonsurgical periodontal treatment) have a weighted average PD reduction of 1.40 mm for those sites with baseline PD of 4 to 6 mm.35”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [35] source

      Section 3.5 (page unavailable) reports a weighted PD reduction of 1.4 mm at 6–8 months for sites considered together, not for the initially shallow sites. For initially shallow sites, it reports 1.5 mm at 3–4 months and 1.6 mm at 6–8 months; the Discussion describes shallow sites as 4–6 mm. (LLM, conf=0.88)

      Checked by a reasoning model — may be wrong.

      Experimental — accuracy not yet measured
  • Premisecitation

    Deeper periodontal pockets experience greater clinical improvements after nonsurgical periodontal treatments than shallower pockets.

    “It is well understood that deeper periodontal pockets (comparing to shallow periodontal pockets) experience greater clinical improvements after nonsurgical periodontal treatments.37”
    Quote in the paperNot a substantial claim1 of 1 sources checked
  • Premisecitation

    Good oral hygiene alone without professional periodontal therapy is not sufficient to reduce probing depths in periodontitis patients.

    “Good oral hygiene alone (without professional periodontal therapy) is not sufficient in healing periodontal pockets (i.e., reducing PD) in periodontitis patients but the test dental gel was able to demonstrate clinically significant PD reductions as a home care dentifrice product in this controlled clinical study.36”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [36] source

      The Abstract says brushing alone cannot achieve the plaque control needed for successful periodontal therapy, and §4.1 reports greater probing-depth improvements when interdental brushes are added to brushing. Neither passage establishes that good oral hygiene without professional periodontal therapy is insufficient to reduce probing depths in patients with periodontitis; the paper compares home-care methods rather than testing that proposition. (LLM, conf=0.76)

      Experimental — accuracy not yet measured
  • Premisecitation

    Arestin (locally administered minocycline) as an adjunct to scaling and root planing has shown probing depth reductions of 1.32 mm (vs 1.08 mm for scaling and root planing alone) and 1.63 mm in its 9-month randomized controlled trial (n=748).

    “Arestin (a locally administered minocycline) as an adjunct to SRP has shown PD reductions of 1.32 mm (compared to 1.08 mm for SRP alone) and 1.63 mm in its 9-month randomized controlled clinical trial (n = 748)”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [33] source

      Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured
  • Premisecitation

    Perio Chip (locally administered chlorhexidine) as an adjunct to scaling and root planing has shown a combined average probing depth reduction of 0.95 mm (vs 0.65 mm for scaling and root planing alone) in its two 9-month randomized controlled trials (n=447).

    “Perio Chip (a locally administered chlorhexidine) also as an adjunct to SRP has shown the combined average of 0.95 mm (compared to 0.65 mm for SRP alone) in its two 9-month randomized controlled clinical trials (n = 447).33,34”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [33] source

      Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured
    • cites [34] source
  • May combine two claims. 15
  • Borderline: one of the tests for a substantial claim is unclear. 1
  • Classified as probably not a substantial claim. 10
  • May combine two claims.

    Premisecitation

    In patients with gingivitis, the 2.6% EDTA dental gel has been shown to enhance plaque removal, improve gingival health, and prevent biofilm reaccumulation compared with a positive control dentifrice.

    “Previous studies have demonstrated enhanced plaque removal, improved gingival health, and prevention of biofilm reaccumulation with the use of the test dental gel than a positive control dentifrice in patients with gingivitis.19,31”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [19]

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

    • cites [31] source

      The Results and Discussion (page unavailable) report greater plaque reduction and less gingival inflammation with the test edathamil gel than with the triclosan/copolymer control in subjects with mild to moderate gingivitis. Our copy does not establish that the gel contained 2.6% EDTA or that it prevented biofilm reaccumulation; lower plaque levels during treatment do not establish prevention of reaccumulation. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
  • May combine two claims.

    Interpretationreasoning

    The improvements in clinical indices were smaller than those reported in previous clinical studies of the test dental gel in gingivitis patients, probably because the recruited population had poor plaque control and generalized severe inflammation at baseline and because these indices have limitations in capturing severity in the high score range.

    “However, these improvements in clinical indices are smaller than the results reported in previous clinical studies for the test dental gel in gingivitis patients.19–21 This probably reflects the fact that the patient population recruited for this study was characterized by poor plaque control and generalized severe inflammation in both groups at baseline and (unlike PD or CAL) these indices have”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [19]

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

    • cites [20] source
    • cites [21]

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

  • May combine two claims.

    Premisecitation

    All previous clinical studies in gingivitis patients demonstrated that the test dental gel is safe and effective for plaque removal and improving gingival health.

    “All previous clinical studies conducted in gingivitis patients have demonstrated that the test dental gel is a safe and effective tool for plaque removal and improving gingival health.19–21,31”
    Quote in the paperNot a substantial claim1 of 4 sources checked
    • cites [19]

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

    • cites [20] source

      The Clinical Data and Conclusion report that, in this three-week study of participants with gingival inflammation, the test gel reduced plaque and improved gingival health. The paper does not establish that all previous clinical studies found these effects, and the Clinical Protocol does not report a safety assessment; preservation of the enamel pellicle alone does not establish that the gel is safe. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [21]

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

    • cites [31]

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

  • Borderline on S1 (asserted), S3 (load-bearing), S4 (based): unclear from the text.

    Findingnone given

    No adverse events were reported during the study.

    “No adverse events were reported during the study.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In the test group, the number of sites with probing depth ≥4 mm decreased from 739 at baseline to 309 at 6 months (58.2% reduction), compared with a decrease from 733 to 371 (49.4%) in the control group.

    “The number of the sites with PD ≥ 4 mm was reduced from 739 at baseline to 309 at 6 months (by 58.2%) for the test group and from 733 to 371 (49.4%) in the control group.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The distribution of site-level probing depth response over 6 months differed between groups (P=0.0497), with 80.9% of test sites and 76.1% of control sites showing probing depth reduction, and 2.3% vs 3.8% showing increase.

    “80.9% of the test sites and 76.1% of the control sites responded well to the respective treatment and showed PD reductions whereas 2.3% of the test sites and 3.8% of the control sites did not respond well and showed increases in PD over the 6-month duration of this study (P = 0.0497).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In the test group, probing depth improved by 1.18 mm and clinical attachment loss improved by 1.09 mm at 6 months, with the 0.09 mm difference representing the amount of gingival recession.

    “The test group has shown improvements in PD of 1.18 mm and in CAL of 1.09 mm at 6 months, the difference of 0.09 mm representing the amount of gingival recession (or the change in FGM) in 6 months.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Probing depth improvements were accompanied by clinical attachment loss gains in both groups, but there was no statistically significant difference in clinical attachment loss gains between groups.

    “These PD improvements were accompanied by the corresponding CAL gains in both groups but there was no statistically significant difference in CAL gains between groups.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Efficacy was analyzed using the full analysis set following the Intent-to-Treat principle, defined as all randomized subjects who completed at least through the 3-month follow-up visit.

    “Efficacy was analyzed based on the full analysis set (FAS) following the Intent-to-Treat principle, defined as all randomized subjects who had completed at least through the follow-up visit at 3 months.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study was approved by the University of California at Irvine IRB (protocol #2013-9778) and conducted in accordance with the Helsinki Declaration.

    “It was approved by the University of California at Irvine, IRB protocol #2013–9778 and all clinical procedures were conducted in accordance with the Helsinki Declaration of 1975, as updated in 2013.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    No significant changes were made in the study design after commencement.

    “No significant changes were made in the study design after commencement of the study.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Both participants and the study examiner were blinded to randomization throughout the study.

    “Both the participants and the study examiner were kept blinded on the randomization and throughout the study.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study was registered on clinicaltrials.gov (NCT02271815).

    “This clinical study was registered on clinicaltrials.gov, with registration number NCT02271815.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Randomization used a block scheme with a fixed block size of four, and allocation concealment was ensured by an independent statistician generating randomization numbers.

    “Randomization was based on a block randomization scheme with a fixed block size of four in order to ensure a balance in sample size across groups over time. To ensure allocation concealment, each qualified subject was assigned a randomization number generated by a random number generator by an independent statistician.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study periodontist was calibrated quarterly by the IRB with a minimum of 90% accuracy for measuring clinical variables.

    “Following clinical variables were recorded at these 3 visits by the same blinded, pre-standardized, experienced study periodontist (who was being calibrated for measuring these clinical variables on a quarterly basis by the IRB with a minimum of 90% accuracy)”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Interim data from this clinical study reported that the test dental gel improved periodontal pocket depths and gingival inflammation and bleeding significantly better than the positive control in the periodontitis population.

    “Interim data from this clinical study was reported in which the test dental gel was found to improve periodontal pocket depths as well as gingival inflammation and bleeding significantly better than the positive control dentifrice in the periodontitis patient population.24”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [24]

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

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

    Interpretationreasoning

    The inflammatory data in Table 5 might indicate a poorly controlled group of patients.

    “The inflammatory data in Table 5 might indicate a poorly controlled group of patients.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationreasoning

    The findings are clinically significant particularly for Stage I and II periodontitis patients who can accelerate healing time and/or extend the time interval of their professional periodontal therapy.

    “The findings are clinically significant particularly for Stage I and II periodontitis patients who can accelerate healing time and/or extend time interval of their professional periodontal therapy including SRP and other (non-invasive and/or invasive) interventions.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The observed reductions in probing depth, including the 0.21 mm between-treatment difference, are clinically significant.
    • Rests on an assumption: The study sample is representative of Stage I and II periodontitis maintenance patients in general.
  • May combine two claims.

    Interpretationcitation

    Both groups showed significant improvement in periodontal clinical parameters in Stage I and II periodontitis patients, which may be attributed to mechanical disruption of the plaque biofilm and the antiplaque and anti-gingivitis properties of the active ingredients in the positive control.

    “Both groups showed significant improvement in the periodontal clinical parameters in patients with Stage I and II periodontitis; this may be attributed to the mechanical disruption of the plaque biofilm and as well as the antiplaque and anti-gingivitis properties of the active ingredients in the positive control group.38,39”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [38] source
    • cites [39] source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisereasoning

    Nonsurgical periodontitis treatments generally have a greater impact in deeper periodontal pockets because there is more room for reduction in probing depth values.

    “Baseline PD values are also important to consider because nonsurgical periodontitis treatments generally have a greater impact in deeper periodontal pockets, because there is more room for reduction in PD values.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premiseown data

    An unpublished in vitro study showed that the test dental gel makes the zeta potential on hydroxyapatite spheres more negative, resulting in a larger repulsive force between the tooth surface and negatively charged bacteria, making it easier to remove plaque and harder for bacteria to reattach.

    “An unpublished in vitro study (available on request) showed that the test dental gel makes the zeta potential (a measure of electrical charge) on hydroxyapatite spheres more negative, thus resulting in a larger repulsive force between the tooth surface and negatively charged bacteria. This repulsion makes it easier to remove bacterial plaque while brushing and harder for the bacteria to attach (or”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationreasoning

    The smaller clinical attachment loss gains and lack of statistical significance compared to probing depth reductions were likely because clinical attachment loss measurements have greater variability than probing depth measurements and because gingival recession is not part of clinical attachment loss measurements.

    “Smaller CAL gains and resulting lack of statistical significance as compared to PD reductions were likely because of a) CAL measurements having greater variability than PD measurements and b) the impact of gingival recession not being a part of the CAL measurements.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Stage I and II periodontitis patients can achieve significant probing depth reductions, reduce inflammation, and improve periodontal health by using the test dental gel as a home care dentifrice during periodontal maintenance therapy and/or between scheduled periodontal maintenance visits.

    “The results of this clinical study show that Stage I and II periodontitis patients can achieve significant PD reductions, reduce the level of inflammation and improve their periodontal health by using the test dental gel as a home care dentifrice during PMT and/or between scheduled PMT visits.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The observed reductions in probing depth, including the 0.21 mm between-treatment difference, are clinically significant.
    • Rests on an assumption: The study sample is representative of Stage I and II periodontitis maintenance patients in general.
23 of 23
  • The paper relies on this without support.

    The observed reductions in probing depth, including the 0.21 mm between-treatment difference, are clinically significant.

    “The findings are clinically significant particularly for Stage I and II periodontitis patients who can accelerate healing time and/or extend time interval of their professional periodontal therapy including SRP and other (non-invasive and/or invasive) interventions.”
  • The paper relies on this without support.

    The study sample is representative of Stage I and II periodontitis maintenance patients in general.

    “The results of this clinical study show that Stage I and II periodontitis patients can achieve significant PD reductions, reduce the level of inflammation and improve their periodontal health by using the test dental gel as a home care dentifrice during PMT and/or between scheduled PMT visits.”
  • The paper relies on this without support.

    The 6-month study duration is sufficient to assess the effect of the test dentifrice on probing depth.

    “Study duration was 6 months (180 days); subjects were evaluated at Visit 1–(day 0 or baseline), Visit 2 (day 90 ± 3 or 3-month), and Visit 3 (day 180 ± 3 or 6-month).”
  • The paper relies on this without support.

    The positive control dentifrice is an appropriate comparator for evaluating the test dentifrice.

    “Positive control dentifrice: a commercially available dentifrice formulated with 0.454% stannous fluoride‡.”
4 of 4

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.

  • Table reference for baseline-depth categories changes

    Minor

    The results direct readers to Table 2 for probing-depth reductions by initial depth, whereas the discussion directs them to Table 4 for probing-depth changes by baseline category.

  • Clinical-response table number changes

    Minor

    The discussion assigns response rates to Table 2, while the results assign the classification of sites by probing-depth response to Table 3.

  • Disease-site count table number changes

    Minor

    The discussion points to Table 3 for the decrease in disease-site counts, but the results place the reductions in counts at Table 4.

3 of 3

Cites

Flagged first, then by citations

4 of the 43 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. 10.1111/j.1600-051x.1981.tb02039.x · DOI

Cited by

Sorted by citations

Authors
Kaur, M., Geurs, N. C., Cobb, C. M., Otomo‐Corgel, J., Takesh, T., Lee, J. H., Lam, T. M., Lin, K., Nguyen, A., Nguyen, B. L., & Wilder‐Smith, P.
Affiliations
  • University of Alabama at Birmingham (US)
  • University of Missouri–Kansas City (US)
  • University of California, Los Angeles (US)
  • University of California, Irvine (US)
  • Beckman Laser Institute and Medical Clinic Department of Dentistry, University of California at Irvine Irvine California USA
Corresponding author
Kaur, Maninder
Venue
Journal of Periodontology
Publisher
Wiley
Published
2021-02-02
Volume
92
Issue
9
Pages
1286-1294
ISSN
  • 0022-3492 (ISSN-L)
  • 1943-3670
OpenAlex
W3111479591
Cited by
11
References
43
Citations by year
2025: 1 · 2024: 3 · 2023: 2 · 2022: 2 · 2021: 3
FWCI
1.12
Type
journal article
Language
en
Open access
Locations
  • Journal of Periodontology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
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
toothpaste, probing depth reduction, gingivitis, home care, stannous fluoride, plaque index, modified gingival index, modified sulcus bleeding index
MeSH terms
Dental Plaque Index, Dentifrices, Double-Blind Method, Gingivitis, Humans, Periodontitis, Tin Fluorides

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