A randomized double‐blind clinical trial evaluating comparative plaque and gingival health associated with commercially available stannous fluoride‐containing dentifrices as compared to a sodium fluoride control dentifrice
Background Gingivitis is a non‐specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflamma...
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| Veröffentlicht in: | Journal of periodontology (1970) Jg. 94; H. 9; S. 1112 - 1121 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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01.09.2023
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| ISSN: | 0022-3492, 1943-3670, 1943-3670 |
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| Abstract | Background
Gingivitis is a non‐specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride‐containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti‐tartar agent to reduce plaque index and gingival index over a 3‐month study period compared to other commercially‐available fluoride‐containing dentifrices.
Methods
This double‐blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride‐containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2‐D4). One hundred fifty subjects participated over a 3‐month period. Co‐primary endpoints were improvements in plaque index (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 dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially‐available dentifrices tested (p < 0.00001).
Conclusions
A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices. |
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| AbstractList | A new stannous fluoride dental gel toothpaste demonstrated significant improvements in plaque, gingival inflammation and bleeding on probing compared with other commercially stannous fluoride dentifrices as well as a sodium fluoride control dentifrice. Gingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti-tartar agent to reduce plaque index and gingival index over a 3-month study period compared to other commercially-available fluoride-containing dentifrices. This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride-containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2-D4). One hundred fifty subjects participated over a 3-month period. Co-primary endpoints were improvements in plaque index (PI) and modified gingival index (mGI) from baseline values. No professional cleaning was performed during the study period. All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially-available dentifrices tested (p < 0.00001). A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices. Gingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti-tartar agent to reduce plaque index and gingival index over a 3-month study period compared to other commercially-available fluoride-containing dentifrices.BACKGROUNDGingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti-tartar agent to reduce plaque index and gingival index over a 3-month study period compared to other commercially-available fluoride-containing dentifrices.This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride-containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2-D4). One hundred fifty subjects participated over a 3-month period. Co-primary endpoints were improvements in plaque index (PI) and modified gingival index (mGI) from baseline values. No professional cleaning was performed during the study period.METHODSThis double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride-containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2-D4). One hundred fifty subjects participated over a 3-month period. Co-primary endpoints were improvements in plaque index (PI) and modified gingival index (mGI) from baseline values. No professional cleaning was performed during the study period.All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially-available dentifrices tested (p < 0.00001).RESULTSAll subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially-available dentifrices tested (p < 0.00001).A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices.CONCLUSIONSA new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices. Background Gingivitis is a non‐specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride‐containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti‐tartar agent to reduce plaque index and gingival index over a 3‐month study period compared to other commercially‐available fluoride‐containing dentifrices. Methods This double‐blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride‐containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2‐D4). One hundred fifty subjects participated over a 3‐month period. Co‐primary endpoints were improvements in plaque index (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 dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially‐available dentifrices tested (p < 0.00001). Conclusions A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices. |
| Author | Cobb, Charles M. Geisinger, Maria L. Takesh, Thair Otomo‐Corgel, Joan Novy, Brian Geurs, Nicolaas C. Jacobsen, Peter L. Wilder‐Smith, Petra |
| AuthorAffiliation | University of Missouri-Kansas City, Department of Periodontology University of The Pacific, Arthur A. Dugoni School of Dentistry Harvard University, School of Dental Medicine University of California at Irvine, Beckman Laser Institute and Medical Center, Department of Dentistry University of California at Los Angeles, School of Dentistry, Department of Periodontology University of Alabama at Birmingham School of Dentistry, Department of Periodontology Department of Ecology and Evolutionary Biology, University of California Irvine, Irvine, California, USA |
| AuthorAffiliation_xml | – name: University of Missouri-Kansas City, Department of Periodontology – name: University of Alabama at Birmingham School of Dentistry, Department of Periodontology – name: University of California at Los Angeles, School of Dentistry, Department of Periodontology – name: University of The Pacific, Arthur A. Dugoni School of Dentistry – name: Harvard University, School of Dental Medicine – name: Department of Ecology and Evolutionary Biology, University of California Irvine, Irvine, California, USA – name: University of California at Irvine, Beckman Laser Institute and Medical Center, Department of Dentistry |
| Author_xml | – sequence: 1 givenname: Maria L. orcidid: 0000-0003-0383-7079 surname: Geisinger fullname: Geisinger, Maria L. email: miagdds@uab.edu organization: University of Alabama – sequence: 2 givenname: Nicolaas C. surname: Geurs fullname: Geurs, Nicolaas C. organization: University of Alabama – sequence: 3 givenname: Brian surname: Novy fullname: Novy, Brian organization: Harvard University – sequence: 4 givenname: Joan surname: Otomo‐Corgel fullname: Otomo‐Corgel, Joan organization: University of California – sequence: 5 givenname: Charles M. orcidid: 0000-0003-0844-2738 surname: Cobb fullname: Cobb, Charles M. organization: University of Missouri – sequence: 6 givenname: Peter L. surname: Jacobsen fullname: Jacobsen, Peter L. organization: University of the Pacific – sequence: 7 givenname: Thair surname: Takesh fullname: Takesh, Thair organization: University of California – sequence: 8 givenname: Petra surname: Wilder‐Smith fullname: Wilder‐Smith, Petra organization: University of California Irvine |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37016272$$D View this record in MEDLINE/PubMed |
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| Copyright | 2023 The Authors. published by Wiley Periodicals LLC on behalf of American Academy of Periodontology. 2023 The Authors. Journal of Periodontology published by Wiley Periodicals LLC on behalf of American Academy of Periodontology. |
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| Issue | 9 |
| Keywords | oral hygiene bleeding gingivitis inflammation plaque control prevention |
| Language | English |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 Author Contributions: P Wilder-Smith contributed to the conception, study design and management, clinical observation, data collection, and evaluation. T. Takesh contributed to study management and design. P Wilder-Smith and T Takesh also contributed to, statistical design, data analysis, and data interpretation; M. Geisinger contributed to data interpretation, drafted and critically revised the manuscript; C Cobb, J Otomo Corgel, N Geurs, P Jacobsen, and B Novy contributed to data interpretation, and critical manuscript revision. All authors gave final approval and agreed to be accountable for all aspects of the work to ensure that questions related to the accuracy or integrity of any part of the work were appropriately investigated and resolved. |
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Gingivitis is a non‐specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis.... Gingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral... A new stannous fluoride dental gel toothpaste demonstrated significant improvements in plaque, gingival inflammation and bleeding on probing compared with... |
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| SubjectTerms | Analysis of Variance bleeding Dental Plaque - drug therapy Dental Plaque - prevention & control Dental Plaque Index Dentifrices - therapeutic use Double-Blind Method Edetic Acid Fluorides - therapeutic use gingivitis Gingivitis - drug therapy Humans inflammation Inflammation - drug therapy oral hygiene plaque control prevention Sodium Fluoride - therapeutic use Tin Fluorides - therapeutic use |
| Title | A randomized double‐blind clinical trial evaluating comparative plaque and gingival health associated with commercially available stannous fluoride‐containing dentifrices as compared to a sodium fluoride control dentifrice |
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