1. Anti-calculus Efficacy of a Stabilized Stannous Fluoride Dentifrice in a 3-month Clinical Trial

Anti-calculus Efficacy of a Stabilized Stannous Fluoride Dentifrice in a 3-month Clinical Trial

Reference: Milleman JL, He T, Anastasia MK. J Dent Res 2017; 96 (Spec Iss A): Abstract 2816.

KEY CLINICAL FINDINGS

  • Subjects using the stabilized stannous fluoride (SnF2) dentifrice demonstrated 15.1% less calculus at Week 6 (P=0.05) and 21.7% less calculus at Month 3 (P<0.01) compared to subjects in the control group.
  • Both test products were well tolerated.

Figure. Calculus scores (VMI) per group.

Significant difference between groups (P<0.05) using analysis of covariance.

N=78. *Significant difference between groups (P<0.05) using analysis of covariance.

OBJECTIVE

To assess the calculus prevention benefit of an experimental stabilized SnF2 dentifrice relative to a negative control dentifrice.

STUDY DESIGN

  • This was a 3-month, parallel-group, double-blind, randomized and controlled clinical trial.
  • Subjects received a dental prophylaxis and then entered a 2-month run-in phase. At the end of 2 months, subjects received a Volpe-Manhold Index (V-MI) calculus examination.
  • Qualified subjects who formed a minimum of 9 mm of calculus on the lingual surfaces of the six mandibular anterior teeth received another prophylaxis and were randomly assigned to one of the two treatments:
  •  

    - Experimental 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble) with zinc to control calculus; or

    - Negative control dentifrice (Colgate® Cavity Protection, Colgate-Palmolive).

     

  • Subjects brushed with their assigned product twice daily using a standard manual toothbrush, one minute per brushing, during the 3-month trial.
  • Safety and calculus measurements were taken via Oral Soft Tissue and Volpe-Manhold Index examinations at Baseline, Week 6 and Month 3..
  • Treatment groups were compared using analysis of covariance. All statistical tests were two-sided with a 5% level of significance.

CLINICAL COMMENT

Calculus build-up can lead to less efficient oral hygiene and tooth discoloration, as well as extending the time required for a dental prophylaxis. This research demonstrated a directional anti-calculus benefit for the SnF2 dentifrice relative to the control dentifrice in as early as 6 weeks. The relative benefit for the SnF2 dentifrice was even greater after 12 weeks of use. Dental professionals should consider recommending the SnF2 dentifrice for patients who form calculus, as it also improves gingival health and strengthens enamel.

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