Safety and efficacy of a novel tartar control dentifrice containing 3.3% pyrophosphate: a controlled six-month clinical trial.
This study was undertaken to establish the tartar control efficacy and long-term safety of a new tartar control dentifrice that was formulated to enhance aesthetics and consumer acceptability. In a partially randomized, examiner-blind clinical trial, the experimental dentifrice, Crest MultiCare with 3.3% pyrophosphate, was compared to two currently marketed control dentifrices, Crest Regular Paste or Crest Tartar Protection Paste with 5.0% pyrophosphate. The eight-month trial model included a two-month pretest period to establish calculus formation after prophylaxis, followed by a six-month test period to evaluate efficacy and safety. Following the pretest period, 456 subjects were allocated to one of the three treatment groups and then monitored for calculus accumulation. After three and six months' test product use, the Crest MultiCare group experienced reductions in calculus accumulation of 28.9% and 32.3%, respectively compared to the regular control dentifrice. Over the six-month observation period, the experimental tartar control and the marketed tartar control dentifrices were comparable on adverse event frequency, type or severity, and no subject discontinued treatment due to an oral soft tissue adverse event. In this partially randomized and controlled six-month clinical trial, this new dentifrice exhibited tartar control efficacy, with a comparable overall safety profile to a marketed tartar control dentifrice.
Segreto
V A
VA
University of Texas Health Sciences Center at San Antonio, USA.
Stevens
D P
DP
Schulte
M C
MC
Fortna
R H
RH
Gerlach
R W
RW
D000328:Adult; D000704:Analysis of Variance; D003728:Dental Calculus / Q000517:prevention & control*; D011756:Diphosphates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000627:therapeutic use*; D014993:Xylitol / Q000627:therapeutic use*
C115762:Crest Multicare; D011756:Diphosphates; D012969:Sodium Fluoride; D014993:Xylitol