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Relationship between 1-, 3-, and 6-Month Gingival Bleeding Outcomes.

T He1, J Grender1, S Farrell1

  • 1The Procter & Gamble Company, Mason, OH, USA.

JDR Clinical and Translational Research
|November 3, 2023
PubMed
Summary
This summary is machine-generated.

Stannous fluoride (SnF2) dentifrice significantly reduces gingival bleeding within 1 month, with effects maintained through 6 months. Early 1-month evaluations accurately predict longer-term antigingivitis efficacy.

Keywords:
clinical trialdentifricegingivitisstannous fluoridestatistical modeltreatment efficacy

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Area of Science:

  • Oral health research
  • Periodontal disease management
  • Clinical trial methodology

Background:

  • Systematic reviews indicate consistent antigingivitis effects of stannous fluoride (SnF2) dentifrice at 3- and 6-month intervals.
  • The relationship between early (1-month) and later (3- and 6-month) gingivitis responses to SnF2 dentifrice has not been previously investigated.

Purpose of the Study:

  • To analyze the relationship between 1-, 3-, and 6-month gingival bleeding outcomes in clinical studies.
  • To determine if early gingivitis assessments can predict longer-term efficacy of SnF2 dentifrice.

Main Methods:

  • Pooled analysis of randomized, double-blinded, controlled clinical trials (1995-2022) comparing 0.454% SnF2 dentifrice to negative controls.
  • Primary endpoint: number of bleeding sites (LSGI or Gingival Bleeding Index).
  • Inclusion criteria: studies with 3-month assessments and at least 1- or 6-month assessments.

Main Results:

  • Gingival bleeding efficacy significantly increased from 1 to 3 months (P < 0.0001) and plateaued from 3 to 6 months (P = 0.007).
  • Bleeding reduction established by 1 month was maintained through 3 and 6 months (R² = 0.857).
  • Gingival bleeding and gingivitis efficacy (LSGI) were highly correlated (R² = 0.874).

Conclusions:

  • A clear relationship exists between 1-, 3-, and 6-month gingival bleeding outcomes with SnF2 dentifrice.
  • Antigingivitis efficacy evaluations can be reliably conducted as early as 1 month, correlating with 3- and 6-month results.
  • 1-month study durations are viable for knowledge acquisition, improving research efficiency and informing clinical practice.