User's Manual

Plaque Removal
in vivo study
Comparison of plaque removal in
orthodontic subjects by Sonicare FlexCare
and a manual toothbrush
DeLaurenti M, Putt M, Milleman J, Jenkins W, Wei J, Strate J. Plaque Removal by Sonicare and Manual
Toothbrushes in Orthodontic Subjects. J Dent Res 87 (spec Iss B): 2044, 2008
Objective To compare the plaque removal and gingivitis reduction ability for the Sonicare
FlexCare (ProResults brush head) and Oral-B P-40
®
manual toothbrush in
orthodontic population.
Methodology
Ninety-ve healthy orthodontic subjects aged 12 years and older participated in a
single-blind, randomized, parallel group clinical study assessing gingivitis and plaque
over time for the Sonicare FlexCare and a manual toothbrush. All subjects were
routine manual toothbrush users. At Visit 1, subjects were screened for eligibility
(Modied Bonded Bracket Index (BBI) >2.0; Pocket depth ≤ 4mm). At Visit 2,
subjects received a prophylaxis and were randomized to a treatment arm. Subjects
were trained and given brushing instructions to use the assigned test device twice
daily at home for two minutes. Subjects abstained from oral hygiene for 12-24 hours
before each visit. At subsequent visits, safety and BBI were assessed before and after
a two minute supervised brushing. Secondary efcacy measurements included
Turesky-Modied Quigley-Hein Plaque Index (TPI) on tooth surfaces without
brackets and a full-mouth Löe and Silness Gingival Index (LSGI). ANOVA was used
for statistical analysis.
Results
The Sonicare FlexCare demonstrated superior plaque reduction in a single brushing
on the buccal (bracketed) surfaces assessed by the Bonded Bracket Index compared
to a manual toothbrush at the two-week and four-week evaluations (overall p<0.0001
at two weeks, p<0.0001 at four weeks).
The Sonicare FlexCare demonstrated signicantly superior reduction in plaque over
time (two and four weeks) on the lingual surfaces assessed by the Turesky-Modied
Quigley-Hein Plaque Index compared to a manual toothbrush (overall p=0.0221 at
two weeks and p=0.0025 at four weeks).
The Sonicare FlexCare demonstrated signicantly superior plaque reduction in a single
brushing on the lingual surfaces assessed by the Turesky-Modied Quigley-Hein Plaque
Index compared to a manual toothbrush at the two-week and four-week evaluations
(overall p=0.0001 at two weeks, overall p<0.0001 at four weeks).
The mean scoring Löe and Silness Gingival Index value was low (1.14, std 0.10)
indicating that the population presented with healthy gingivae. Both groups, however,
were able to demonstrate statistically signicant improvement vs. baseline over time
(overall p<0.0001).
Sonicare FlexCare /
FlexCare+