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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| Published in: | Journal of periodontology (1970) Vol. 94; no. 4; pp. 509 - 518 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01.04.2023
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| Subjects: | |
| ISSN: | 0022-3492, 1943-3670, 1943-3670 |
| Online Access: | Get full text |
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| Summary: | 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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| Bibliography: | 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. |
| ISSN: | 0022-3492 1943-3670 1943-3670 |
| DOI: | 10.1002/JPER.22-0254 |