Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
319
Dentifrice on plaque, gingivitis, and bleeding.
All Sum Research Center Ltd.
Mississauga, Ontario, Canada
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy
Mean Within-Treatment Whole-Mouth 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: baseline, six weeks, 3 months and 6 months
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy
Mean Within-Treatment Whole-Mouth 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: baseline, six week, three months, and six months
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy
Mean Within-Treatment Whole-Mouth 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: baseline, six weeks, three months, and six months
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