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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Published in:Journal of periodontology (1970) Vol. 94; no. 9; pp. 1112 - 1121
Main Authors: Geisinger, Maria L., Geurs, Nicolaas C., Novy, Brian, Otomo‐Corgel, Joan, Cobb, Charles M., Jacobsen, Peter L., Takesh, Thair, Wilder‐Smith, Petra
Format: Journal Article
Language:English
Published: United States 01.09.2023
Subjects:
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
oral hygiene
bleeding
gingivitis
inflammation
plaque control
prevention
ISSN:0022-3492, 1943-3670, 1943-3670
Online Access:Get full text
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Summary: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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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.
ISSN:0022-3492
1943-3670
1943-3670
DOI:10.1002/JPER.22-0675