The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
290
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
Silverstone Research Group
Las Vegas, Nevada, United States
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time frame: 14 days
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Time frame: 28 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time frame: 14 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time frame: 28 days
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time frame: 14 days
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time frame: 28 days
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Manual Toothbrush used twice daily, 1 minute.