1. A Randomized Clinical Trial to Evaluate a Daily Two-Step Dentifrice and Gel System in the Prevention of Stain, Plaque and Calculus following a Dental Prophylaxis

A Randomized Clinical Trial to Evaluate a Daily Two-Step Dentifrice and Gel System in the Prevention of Stain, Plaque and Calculus following a Dental Prophylaxis

Reference: Gerlach R, Farrell S, Anastasia MK, Amini P. J Dent Res 2016; 95 (Spec Iss A): Abstract 0093.

KEY CLINICAL FINDINGS

  • A 2-step dentifrice and whitening gel system helped maintain the cleaning results of a dental prophylaxis versus a regular anti-cavity dentifrice used as a negative control through 2.5 months. Step 1 is a 0.454% stannous fluoride dentifrice and Step 2 is a 3% hydrogen peroxide whitening gel.
  • After 10 weeks of twice daily use, the 2-step dentifrice and gel system exhibited statistically lower (P<0.001) percent accumulations versus the control group in tooth stain (73.4%), plaque (30.5%), and calculus (58.6%). See Figures 1–3.
  • Both products were well-tolerated.

Figure 1. Tooth Stain Scores

Tooth Stain Scores-Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means

* Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means
** P<0.0005

Figure 2. Plaque Scores

Plaque Scores-Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means.

* Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means.
** P<0.0001

Figure 3. Calculus Scores

Calculus Scores-Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means

* Baseline and post-prophy scores are means; Week 4 and Week 10 scores are adjusted means.
** P<0.01

OBJECTIVE

To assess the effectiveness of a daily 2-step dentifrice and gel system to prevent the formation of stain, calculus and plaque after a dental prophylaxis.

METHODS

  • This was a randomized, controlled, examiner-blind, 2-treatment parallel group study. Forty-eight healthy adult volunteers with evidence of plaque and either stain or calculus completed the trial.
  • Following a whole-mouth dental prophylaxis, subjects were randomized to one of two groups:
  • - Negative control - 0.76% sodium monofluorophosphate dentifrice (Colgate® Cavity Protection, Colgate-Palmolive)

    - Daily 2-step dentifrice and gel system (Crest® PRO-HEALTH [HD]) - Step 1, 0.454% stannous fluoride dentifrice; Step 2, 3% hydrogen peroxide whitening gel

Both groups brushed twice daily with a soft manual toothbrush (Oral-B® Indicator, Procter & Gamble).

  • Stain (Lobene Index1), calculus (Volpe-Manhold Index2) and plaque (Rustogi Modification of the Navy Plaque Index3) were measured clinically prior to receiving a dental prophylaxis, immediately after a dental prophylaxis, and after 4 and 10 weeks of product use.

1 Lobene RR. Effect of dentifrices on tooth stain with controlled brushing. J Am Dent Assoc. 1968;77:849-855.
2 Volpe AR, Manhold JH, Hazen SP. In vivo calculus assessment. I. A method and its examiner reproducibility. J Periodontol. 1965;36:32-38.
3 Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the modified Navy Plaque Index to increase efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3 (Suppl C):C9-12.

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