Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
181
20% sodium bicarbonate
Negative control
BioSci Research Canada, Ltd
Mississauga, Ontario, Canada
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy
change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.
Time frame: 16 weeks
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy
change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Time frame: 16 weeks
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy
change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5.
Time frame: 16 weeks
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