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
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...
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| Vydané v: | Journal of periodontology (1970) Ročník 94; číslo 4; s. 509 - 518 |
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| Hlavní autori: | , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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United States
01.04.2023
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| ISSN: | 0022-3492, 1943-3670, 1943-3670 |
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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. |
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| AbstractList | 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. 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. 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. 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)]. The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice. 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.BACKGROUNDGingivitis 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.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.METHODSThis 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.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)].RESULTSAll 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)].The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.CONCLUSIONSThe novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice. |
| Author | Yang, Susan Meishan Geisinger, Maria L. Takesh, Thair Goshtasbi, Arezou Lin, Kairong Wink, Cherie Wilder‐Smith, Petra |
| AuthorAffiliation | 1 Beckman Laser Institute, University of California, Irvine, California, USA 2 Concorde College of Dental Hygiene, Garden Grove, California, USA 3 University of Alabama at Birmingham, Birmingham, Alabama, USA |
| AuthorAffiliation_xml | – name: 1 Beckman Laser Institute, University of California, Irvine, California, USA – name: 2 Concorde College of Dental Hygiene, Garden Grove, California, USA – name: 3 University of Alabama at Birmingham, Birmingham, Alabama, USA |
| Author_xml | – sequence: 1 givenname: Thair surname: Takesh fullname: Takesh, Thair organization: Beckman Laser Institute, University of California – sequence: 2 givenname: Arezou surname: Goshtasbi fullname: Goshtasbi, Arezou organization: Concorde College of Dental Hygiene – sequence: 3 givenname: Kairong surname: Lin fullname: Lin, Kairong organization: Beckman Laser Institute, University of California – sequence: 4 givenname: Susan Meishan surname: Yang fullname: Yang, Susan Meishan organization: Beckman Laser Institute, University of California – sequence: 5 givenname: Cherie surname: Wink fullname: Wink, Cherie organization: Concorde College of Dental Hygiene – sequence: 6 givenname: Maria L. surname: Geisinger fullname: Geisinger, Maria L. email: miagdds@uab.edu organization: University of Alabama at Birmingham – sequence: 7 givenname: Petra surname: Wilder‐Smith fullname: Wilder‐Smith, Petra organization: Beckman Laser Institute, University of California |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35980316$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1016_j_identj_2023_04_005 crossref_primary_10_1002_JPER_22_0675 |
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| Keywords | oral hygiene gingivitis inflammation plaque control prevention |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 AUTHOR CONTRIBUTIONS Thair Takesh and Arezou Goshtasbi contributed to study conception, design, data collection, statistical design, data analysis, and data interpretation; Kairong Lin, Susan M. Yang, and Cherie Wink contributed to clinical observation, execution, and data collection; Maria L. Geisinger contributed to data interpretation and drafted and critically revised the manuscript; Petra Wilder-Smith contributed to study conception, design, data collection, statistical design, data analysis, 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 are appropriately investigated and resolved. |
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Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is 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. Enhanced oral... |
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| SubjectTerms | Dental Plaque - therapy Dental Plaque Index Dentifrices - therapeutic use Double-Blind Method Edetic Acid gingivitis Gingivitis - drug therapy Humans inflammation Inflammation - drug therapy oral hygiene plaque control prevention Sodium Fluoride - therapeutic use Tin Fluorides - therapeutic use |
| Title | 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 |
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