The objective of this study is to determine and compare the effectiveness of a manual toothbrush with a 360-degree mouth cleaner design versus a standard flat-trim manual toothbrush in achieving whole mouth bacterial load reduction
The Primary Objective of this study is to determine and compare the effectiveness of a manual toothbrush with a 360-degree mouth cleaner design (Test Product) versus a standard flat-trim manual toothbrush (Control Product) in achieving whole mouth bacterial load reduction in adult subjects, as measured by the change in LOG CFU/mL of saliva from Pre-brushing Baseline to 30 minutes and 2 hours Post-Brushing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Colgate 360 SupraClean Manual Toothbrush brush with 0.76% Na MFP, (1000 ppm F) toothpaste single, supervised on-site use (2- minute brushing) w/ approx. 1.2g full ribbon
Colgate Adult Extra Clean soft-bristle toothbrush brush with 0.76% Na MFP, (1000 ppm F) toothpaste single, supervised on-site use (2- minute brushing) w/ approx. 1.2g full ribbon
M Clinical
Heredia, Costa Rica
measure whole mouth bacterial load (measured as LOG CFU/mL) by collecting saliva samples
Change is calculated by comparing the bacterial counts at the Pre-brushing Baseline time point against the bacterial counts at the two post- brushing time points: 30 minutes Post-Brushing and 2 hours Post-Brushing when using Test product and then Control product
Time frame: Pre- brushing Baseline, 30 minutes Post-Brushing, and 2 hours Post-Brushing only during the supervised, on-site brushing session for the Test Product and Control product treatment period
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