1. A Randomized Clinical Trial to Assess Gingivitis, Plaque, and Tooth Color after Use of a Daily Two-Step Dentifrice and Gel System versus Chlorhexidine Rinse

A Randomized Clinical Trial to Assess Gingivitis, Plaque, and Tooth Color after Use of a Daily Two-Step Dentifrice and Gel System versus Chlorhexidine Rinse

Reference: Gerlach RW, Sagel PA, Barker ML, et al. J Dent Res 2015; 94 (Spec Iss A): Abstract 0293.

KEY CLINICAL FINDINGS

Overall

  • Use of a daily 2-step dentifrice and gel system resulted in plaque and gingivitis reductions comparable to chlorhexidine (with regular brushing) plus provided tooth whitening benefits. Step 1 is a 0.454% stannous fluoride dentifrice and Step 2 is a whitening gel.

Plaque and Gingivitis

  • The daily 2-step dentifrice and gel system group and the chlorhexidine group had statistically significant (P<0.01) improvements in plaque area and gingivitis color measurements at both Day 7 and Day 21 from Day 0. See Figures 1 and 2.
  • There were no statistically significant differences between the 2-step dentifrice and gel system group and the chlorhexidine group in plaque and gingivitis reduction at Day 7 and Day 21.

Tooth Color

  • The 2-step dentifrice and gel system group demonstrated statistically significantly (P<0.03) greater improvement in tooth color lightness (L*) values compared to the chlorhexidine group at Day 7 and 21. See Figure 3.

Figure 1. Percent Plaque Coverage

Percent Plaque Coverage

* Day 7 and Day 21 are Means adjusted for Day 0. For both groups, Day 7 and Day 21 scores were statistically significantly different (P<0.0001) from Day 0.

Figure 2. Gingivitis (Digital Gingival Imaging, a higher G-value indicates less gingivitis)

Digital Gingival Imaging, a higher G-value indicates less gingivitis)

* Day 7 and Day 21 are Means adjusted for Day 0 For both groups, Day 7 and Day 21 scores were statistically significantly different (P<0.007) from Day 0.

Figure 3. Tooth color lightness (L*) change from baseline (Combined Arches, Analysis of Covariance)

Tooth color lightness (L*) change from baseline

OBJECTIVE

To assess the effect of a daily 2-step dentifrice and gel system versus chlorhexidine (with regular brushing) using imaging of plaque, gingivitis and tooth color in an induced gingivitis model.

METHODS

  • This was a single-blind, supervised-use, randomized, parallel-group, positive-controlled clinical trial.
  • During the Oral Hygiene Phase, up to 40 healthy volunteers received a dental prophylaxis and used regular oral hygiene products under supervision for one week. During the Induced Gingivitis Phase, subjects refrained from oral hygiene for two weeks. After gingivitis induction, subjects were randomized into 2 treatment groups for the test phase: 2-step dentifrice and gel system or chlorhexidine mouth rinse plus regular brushing. Gingivitis (RGB*), plaque (area %) and tooth color (L*a*b*) were measured by digital image analysis after one and three weeks of product use. See Figure 4.
  • During the test phase, subjects were randomly assigned to one of the following treatment groups based on average gingival redness (G) score and pre-brush percent plaque coverage:
  1. Daily 2-Step System (Crest® PRO-HEALTH [HD], Procter & Gamble): Step 1, 0.454% stannous fluoride dentifrice; Step 2, 3% hydrogen peroxide whitening gel and a soft, regular manual toothbrush (Oral-B® Indicator™).
  2. 0.12% chlorhexidine gluconate oral rinse (Oral-B®), 0.76% sodium monofluorophosphate dentifrice (Colgate® Cavity Protection toothpaste) and a soft, regular manual toothbrush (Oral-B® Indicator™).
  • Subjects were instructed on product use. Study personnel supervised product use twice daily at least 5 and up to 7 days a week until the end of the study.

Figure 4. Study Design

Oral Hygiene Induced Gingivitis Study Design

* Standard Test Method for Objective Measurement of Gingival Color Using Digital Still Cameras. ASTM E2545 - 07(2012). http://www.astm.org/Standards/E2545.htm

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