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Efficacy of interdental calibrated brushes on bleeding reduction in adults: A 3-month randomized controlled clinical trial

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This study investigated the effect of interdental brushes on the reduction of interproximal bleeding in adults without periodontal disease. Forty-six adults were enrolled in a 3-month, observer-blinded, parallel-group randomized control trial. The test group used a standard manual toothbrush twice daily and an interdental brush daily. The control group used a standard manual toothbrush. At each visit, a calibrated colorimetric probe was used in all interdental spaces to determine the appropriate size of the interdental brush required, the brush of the corresponding size was introduced into the interproximal space, and the presence of bleeding was recorded. The outcome was the frequency of bleeding after application of the appropriate interdental brush. All participants were evaluated 1 wk, 1 month, and 3 months after the baseline visit. The overall preventive fraction with respect to bleeding frequency was 46% at 1 wk and 72% at 3 months. More bleeding reduction was observed in anterior sites than in posterior sites (80% vs. 69%, respectively). Participants with low baseline bleeding frequency presented with less bleeding (OR = 2.3). This study shows that daily use of calibrated interdental brushes reduces interdental bleeding. These findings may support interdental cleaning as an effective means to help individuals maintain and/or achieve optimal oral health.
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Efficacy of interdental calibrated
brushes on bleeding reduction in
adults: a 3-month randomized
controlled clinical trial
Bourgeois D, Saliasi I, Llodra JC, Bravo M, Viennot S, Carrouel F. Ecacy of
interdental calibrated brushes on bleeding reduction in adults: a 3-month randomized
controlled clinical trial.
Eur J Oral Sci 2016; 00: 000000. ©2016 Eur J Oral Sci
This study investigated the eect of interdental brushes on the reduction of inter-
proximal bleeding in adults without periodontal disease. Forty-six adults were
enrolled in a 3-month, observer-blinded, parallel-group randomized control trial.
The test group used a standard manual toothbrush twice daily and an interdental
brush daily. The control group used a standard manual toothbrush. At each visit, a
calibrated colorimetric probe was used in all interdental spaces to determine the
appropriate size of the interdental brush required, the brush of the corresponding
size was introduced into the interproximal space, and the presence of bleeding was
recorded. The outcome was the frequency of bleeding after application of the
appropriate interdental brush. All participants were evaluated 1 wk, 1 month, and
3 months after the baseline visit. The overall preventive fraction with respect to
bleeding frequency was 46% at 1 wk and 72% at 3 months. More bleeding reduc-
tion was observed in anterior sites than in posterior sites (80% vs. 69%, respec-
tively). Participants with low baseline bleeding frequency presented with less
bleeding (OR =2.3). This study shows that daily use of calibrated interdental
brushes reduces interdental bleeding. These findings may support interdental clean-
ing as an eective means to help individuals maintain and/or achieve optimal oral
health.
Denis Bourgeois
1,
*, Ina Saliasi
1,
*,
Juan Carlos Llodra
1
,
Manuel Bravo
2
, St!
ephane
Viennot
1,
*, Florence Carrouel
3,
*
1
Laboratory ‘Course, Health and Systemic’,
EA4129, University Lyon 1, Lyon, France;
2
Department of Preventive and Community
Health, Faculty of Dental Medicine, University
of Granada, Granada, Spain;
3
Institute of
Functional Genomics of Lyon, UMR5242,
ENS Lyon, University Lyon 1, Lyon, France
*These authors contributed equally to this work.
Denis Bourgeois, Laboratory ‘Course, Health
and Systemic’, EA4129, University Lyon 1, 11
rue Paradin, 69372 F. Lyon, France
E-mail: denis.bourgeois@univ-lyon1.fr
Key words: gingival bleeding; interdental
biofilm; interdental brushes; oral prophylaxis
Accepted for publication August 2016
Disruption of the oral biofilm in interproximal sites by
mechanical methods remains one of the best options
for preventing periodontal disease (1). Well-designed
randomized control trials (RCTs) are required to pro-
vide evidence supporting the clinical practice of the
new hypothesis that interdental cleaning should become
an established part of daily oral hygiene for the reduc-
tion of interproximal plaque in all populations. Origi-
nally, dental professionals recommended that patients
with large embrasure spaces between their teeth should
use interdental brushes (IDBs) (2, 3), mainly to prevent
periodontal destruction. However, with the availability
of a greater range of IDBs calibrated in size and cross-
sectional diameter, IDBs have become a potentially
suitable alternative to dental floss for healthy patients
who have interdental papillae that fill the interdental
space (4, 5).
Oral hygiene instruction (OHI), which includes
instruction in toothbrushing and interdental cleaning, is
eective in disturbing oral biofilm and preventing peri-
odontal diseases, such as gingivitis and periodontitis
(6). Studies have evaluated the eect of OHI on clinical
and immunological parameters and on the microbiolog-
ical profiles of periodontal maintenance participants,
but no studies have evaluated its role in the manage-
ment of gingivitis (7). It is unclear whether the daily
use of IDBs is eective (3) because only low-quality
evidence for IDB-related gingivitis reduction exists. The
eectiveness of interdental/interspace brushes in addi-
tion to standard toothbrushes is not supported by clini-
cal investigations. However, there are conflicting study
results regarding the ecacy of IDBs in reducing the
clinical parameters of gingival inflammation (8). There
is also a lack of consensus regarding whether IDBs are
only suitable for patients with moderate to severe
attachment loss and open embrasures or are also a suit-
able aid for preventing gingivitis in healthy patients
who have sucient interdental space to accommodate
them (9, 10).
The purpose of this study was to determine whether
mechanical cleaning with IDBs, combined with the use
of a manual toothbrush, is more eective than
Eur J Oral Sci 2016; 1–6
DOI: 10.1111/eos.12302
Printed in Singapore. All rights reserved
!2016 Eur J Oral Sci
European Journal of
Oral Sciences
mechanical cleaning with a manual toothbrush alone in
reducing interproximal bleeding in the gums of adults
with gingivitis.
The study hypothesis was that the IDB is an eective
alternative for reducing bleeding in the gums of individ-
uals with gingivitis, allowing them to maintain and/or
achieve optimal oral health and encouraging daily
home use of IDBs.
Material and methods
The guidelines of the CONSORT Statement were followed
in this clinical trial (11). The protocol was declared of
public interest by the National Ethics Committee and was
approved by the National Commission of Informatics and
Liberties, France. It was performed in accordance with the
Code of Ethics established by the Declaration of Helsinki.
The study was performed according to the guidelines of
Good Clinical Practice. Before participation, all partici-
pants received full oral and written information on the
study aims and signed a written consent form.
The workflow design, summarized in Fig. 1, was a
3-month, observer-blinded, single-centre, stratified, paral-
lel-group, RCT with patients allocated (1:1) to the follow-
ing two groups: test group (manual toothbrush and
interdental calibrated brushes); and control group (manual
toothbrush).
Forty-six Caucasian adults, diagnosed as periodontally
healthy, were recruited between September 2014 and
December 2014 from a pool of first-time volunteers who
were referred to the Department of Public Health of the
Faculty of Oral Medicine at the University of Lyon
(UCBL), France. Participants were included if they: (i)
were 1825 yr of age; (ii) had at least 20 natural record-
able teeth, including third molars; (iii) had no signs of
clinical periodontitis; (iv) had no significant dental anoma-
lies or prosthetic restorations or interproximal caries;
(v) reported brushing teeth at least twice per day; (vi) had
no health condition that required antibiotic prophylaxis
before interproximal probing; (vii) had IDB dexterity; and
(viii) lacked experience with interdental cleaning and were
willing to undergo four study visits.
Exclusion criteria comprised: (i) teeth missing as a result
of periodontal disease; (ii) any other concomitant systemic
disorder; (iii) diseases aecting the immune system; (iv)
receiving medication, such as anti-platelet or anti-coagu-
lant agents; (v) pregnancy or breastfeeding; (vi) profes-
sional prophylaxis within 4 wk before the baseline
examination; (vii) history of periodontal disease or treat-
ment; (viii) use of over-the-counter mouthwash; and/or
(ix) undergoing a course of dental or orthodontic treat-
ment. The use of antibiotics during the study period led to
exclusion.
All participants met the criteria described by the Ameri-
can Academy of Periodontology (12), with some modifica-
tions (13). The healthy participants presented 10% of
sites with bleeding on probing (BOP) after 30 s and/or
overt gingival redness, and had no pocket depth of >3 mm
and no clinical attachment loss of >2 mm.
Procedure
Calculation of sample size (sites) was performed using
Sample Power 2.0 (SPSS, Chicago, IL, USA). In the
absence of exact values provided by theory or experience
in this specific area, the t-test for independent groups was
used to detect a power of 80% and 5% alpha error for an
estimated Cohen’s d of 0.5 a medium eect size accord-
ing to Cohen’s scale (14) in bleeding after IDB use. We
needed 128 a-priori sites (64 test and 64 control). After
considering a design eect (owing to sites being clustered
within participants) of 5.0 (estimated from 20 pilot partici-
pants from this study) in estimating the bleeding percent-
age, the sample size increased to 640 sites (=128 95).
Furthermore, after considering an estimated 70% of the
sites available for analysis (i.e. 30% would be excluded
owing to lack of space to introduce the IDB, the presence
of diastema or the lack of teeth), the sample size increases
to 914 sites (=640/0.70). Considering 30 sites per partici-
pant, this results in a minimum sample size of 31 partici-
pants (i.e. approximately 16 participants per group).
To achieve the same sample size in both groups and
simultaneously satisfy the randomization procedure to
achieve balanced groups with respect to the most relevant
variables (sex and baseline bleeding), a stratified (two
levels for sex and two levels for baseline bleeding) block
randomization (computer-assisted) method was used. Base-
line bleeding was defined as the percentage of bleeding
sites, per participant, as follows: a high level of bleeding if
the participant had 30% bleeding sites; and a low level of
bleeding if the participant had <30% bleeding sites. Each
participant was identified using a code. An allocation
schedule was generated by computer by an independent
assistant not involved in the study.
At baseline, the prescreened participants referred to the
clinic for baseline examinations (gingivitis, periodontal
conditions, and bleeding) had refrained from oral hygiene
for at least 8 h but no more than 18 h. A colorimetric
probe (IAP Curaprox; Curaden, Kriens, Switzerland) was
used to evaluate the diameter of the interproximal spaces,
except those between the second and third molars (15), in
order to determine the appropriate size of the IDB for
each site. After the baseline oral examinations and
Fig. 1. Flow chart of the study design. IDB, interdental
brush.
2Bourgeois et al.
assessments of other inclusion/exclusion criteria, qualifying
participants were randomly assigned to one of two groups.
Participants randomized to the control group brushed
twice daily in their usual manner with an American Dental
Association (ADA)-approved fluoride toothpaste and a
soft-bristle toothbrush. Participants randomized to the
active treatment group brushed twice daily in their usual
manner, followed by interdental brushing once daily in the
evening with their IDB formulation determined during the
baseline examination with the colorimetric probe.
Participants in the test group received a manual soft-bris-
tle toothbrush, an ADA-approved fluoride-containing den-
tifrice, and a pack of IDBs of dierent sizes (Curaprox CPS;
Curaden). The first use of the product was conducted under
the supervision of study personnel, following instruction of
IDB use by a qualified public health professor. The instruc-
tion comprised verbal instructions on interdental brushing
supported by practical demonstration on a plastic model.
No further oral-hygiene instructions were provided. All
other brushings were unsupervised, and the participants
were required to maintain a diary card. Participants were
instructed to mark the box corresponding to the current
date on the diary card every evening after performing their
interdental brushing to ensure that brushing was performed
every day. Participants in the control group received an
ADA-approved fluoride-containing dentifrice and a soft-
bristle toothbrush at their baseline visit. No other oral-
hygiene procedures were permitted, including teeth cleaning
and dental procedures. At baseline (T0), and at 1-wk (T1),
1-month (!2 d) (T2), and 3-month (T3) visits, participants
had brushed or used their IDBs at least 8 h previously but
no more than 18 h previously. Two examiners collected the
data at T0, T1, T2, and T3, and were blinded to the partici-
pant group allocation, which was assigned by an assistant
not involved in the examination.
All participants were instructed in the modified Bass
technique and were instructed to use a manual, compact-
tuft, soft-bristle toothbrush, twice a day.Participants in
the test group were instructed with the appropriate IDB
sizes determined at baseline and to introduce the cali-
brated IDBs once per day using dierent sizes for dierent
sites.
At each visit during the evaluation period, the colori-
metric probe was used in all interdental spaces for all par-
ticipants in both groups. The procedure consists of
introducing the colorimetric probe into the vestibular
interdental space, inserting it fully, and then noting the
colour that appears in the interdental space on the vestibu-
lar side. This colour corresponds to the colour of the IDB
that is most suitable for the space in question. The prob-
ing protocol was always the same, starting in the 1617
interdental space and finishing in the 4647 interdental
space. Information concerning the IDB diameter for each
interdental space was recorded in a chart, and a copy was
given to the participant. After horizontal probing, the cor-
responding brush was introduced into the interproximal
space, and the presence of bleeding was observed. The
pressure applied by a horizontal brush in the interdental
area should be firm and continuous until reaching maxi-
mum compression with minimal discomfort to the patient.
A visual analogue scale (VAS) was used to estimate the
correlation between the patient’s discomfort perception
and the interproximal pressure (0 =no pain, 10 =unbear-
able pain) (16). The pressure used to place the IDB was
approximately 50100 N cm
"2
(0.200.40 gram-force), and
80% of participants were assigned a VAS score of 1.
The IDBs used are from the CPS range of Curaprox
(Curaden) products. This pack comprises five cylindrical
IDBs with the following characteristics: a colour code
related to the size of the brush; an access diameter defined
by the gauge of the Cural (Curaden) wire core used to stif-
fen the IDB; and an eective cleaning diameter defined by
the length of the synthetic bristles covering the working
part of the device.
Two experienced examiners with graduate training in
periodontics were trained beforehand in the use of the
IAP Curaprox colorimetric probe (Curaden) and had
obtained a minimum kappa value of 0.82 compared with
the gold standard examiner (excellent agreement accord-
ing to the LANDIS &KOCH scale (17). These examiners
were trained in the use of the CPS Curaprox IDBs in a
single cleaning movement, comprising three stages: (i)
place an IDB at the point where the interdental gap
begins, tilt the tip at an angle to the centreline of the
teeth, and push it in gently at the correct angle as far
as the centre of the teeth; (ii) without putting any more
pressure on the brush, hold the handle at 90°to the
teeth; and (iii) push the brush through with care and
then pull it out. The VAS was used (16). Examiners
were blinded to each other, and the two observations
were collected at an interval of at least 15 min. The
kappa statistic for the reproducibility of the pressure
was 0.76 (95% CI: 0.141.38; P=0.02).
Measures
The Bleeding on Interdental Brushing Index (BOIB) was
recorded, as was the bleeding response to the horizontal
pressure applied in the interdental area by a calibrated
IDB (18). After 30 s, bleeding at each gingival unit was
recorded according to the following scale: 0, absence of
bleeding after 30 s; and 1, bleeding after 30 s (19).
Statistical analysis
SPSS Windows 20.0 (IBM, Chicago, IL, USA) was used
for the descriptive statistics (mean values with SD and
percentages) and for the analytical statistics (P-value cal-
culation) in those analyses in which the patient was the
unit of analysis. SUDAAN 7.5 (RTI International,
Research Triangle Park, NC, USA) was used for the
analytical statistics (P-value calculation) in those analy-
ses in which the interproximal site was the unit of anal-
ysis to adjust for clustering (multiple sites within the
patients). The output variable is the interproximal bleed-
ing after IDB use at the interproximal site level. The
statistical methods are indicated in the Table footnotes.
Results
All 46 randomized participants completed the study.
The baseline characteristics of the intervention and con-
trol groups are presented in Table 1. The groups were
broadly similar in terms of the principal variables at
baseline, suggesting a high level of homogeneity
between these two groups.
Table 2 shows the evolution of bleeding during the
trial period. At T0, the percentage of bleeding sites was
34.8% in the control group and 35.9% in the test
Interdental brushing and bleeding 3
group (P=0.88). During T0T3, the evolution of the
percentage of bleeding sites was not significant in the
control group (34.8% at T0 and 37.6% at T3;
P=0.10). In the test group, the frequency of bleeding
sites decreased from 35.9% at T0 to 14.6% at T1, to
10.9% at T2, and to 10.4% at T3 (P=0.008). The pre-
ventive fraction (PF) was 46% at T1, 64% at T2, and
72% at T3.
Analysis of the PF according to localization (ante-
rior sites or posterior sites) showed better eective-
ness results for anterior sites. The PF values in
anterior sites were 80% and 69% in the posterior
sites at 3 months.
Table 3 shows the results of multilevel logistic
regression analysis of the associations between candi-
date predictor variables and the presence of bleeding
in a site after 3 months of interdental brushing. The
OR for the presence of bleeding in the control group
was 4.3. The interdental brushing had poorer results
in participants with high baseline bleeding than in
participants with low baseline bleeding (OR =2.3).
The odds of bleeding were higher in posterior sites
than in anterior sites (OR =2.2). Finally, we found
an inverse relationship between the diameter of the
IDB and the presence of bleeding: a larger diameter
was associated with a smaller amount of bleeding.
Table 1
Baseline characteristics of trial participants according to study
groups (n=46)
Variable
Control
(n=23)
Test
(n=23) P
Sex
Male 16 (69.6) 14 (60.9) 0.757*
Female 7 (30.4) 9 (39.1)
Age (yrs) 22.8 !3.8 22.0 !1.8 0.409
Bleeding risk
High 12 (52.2) 10 (43.5) 0.768*
Low 11 (47.8) 13 (56.5)
Smoker
Yes 8 (34.8) 4 (17.4) 0.314*
No 15 (65.2) 19 (82.6)
Values are given as n(%) or mean !SD.
*Chi-square, with Yates’ correction.
Student’s t-test.
High if 30% bleeding sites, and low if <30% bleeding sites.
Table 2
Bleeding frequency, according to study time point, for sites (in anterior and posterior regions)
in participants in test (n=23) and control (n=23) groups
Zone and study time point
Control Test
Comparison
(P)
% Dierence
§
(eectiveness)
(95% CI)
n(sites)* % !SE
n(sites) % !SE
Anterior
T0 (Baseline) 170 28.2 !6.2 188 28.7 !6.4 0.956
T1 (+1 wk from T0) 170 17.6 !6.1 188 10.6 !3.8 0.335
T2 (+1 month from T0) 170 28.8 !6.4 188 8.0 !3.0 0.005 72 (4896)
T3 (+3 months from T0) 170 29.4 !6.4 188 5.9 !2.9 0.001 80 (59100)
Global P
0.057 0.019
Pairwise comparison** T0 6¼T1, T2, T3
Posterior
T0 (Baseline) 370 37.8 !4.9 380 39.5 !6.5 0.841
T1 (+1 wk from T0) 370 31.1 !4.7 380 16.6 !4.2 0.026 47 (1578)
T2 (+1 month from T0) 370 30.8 !4.8 380 12.4 !3.0 0.002 60 (3783)
T3 (+3 months from T0) 370 41.4 !6.2 380 12.6 !5.3 0.001 69 (4396)
Global P0.227 0.007
Pairwise comparison T0 6¼T1, T2, T3
Anterior +Posterior
T0 (Baseline) 540 34.8 !4.5 568 35.9 !6.2 0.886
T1 (+1 wk from T0) 540 26.9 !4.1 568 14.6 !3.6 0.028 46 (1576)
T2 (+1 month from T0) 540 30.2 !4.7 568 10.9 !2.5 <0.001 64 (4484)
T3 (+3 months from T0) 540 37.6 !5.8 568 10.4 !4.2 <0.001 72 (4996)
Global P0.102 0.008
Pairwise comparison T0 6¼T1, T2, T3
*Eective sample size for each estimation. For example, the first number value (n=170) is obtained from the following calculation: 23
control patients 910 anterior sites/patient =230 sites, minus sites with diastemas (n=12), lack of tooth (n=7) or with no space to intro-
duce the interproximal brush along the follow-up (n=41), gives eective sample =170 sites (=230 minus 12 minus 7 minus 41).
Standard errors (SEs) corrected for complex sampling (multiple sites within the mouth), using the DESCRIPT procedure in SUDAAN
7.0.
Values of Pcorrected for complex sampling (multiple sites within the mouth), using chi-square analysis (CROSSTAB procedure in
SUDAAN 7.0).
§
Per cent dierence between control (C) and test (T) subjects ={[(%C"%T)/%C]9100}.
95% CI =%!1.96 SE, where the standard error (SE) is calculated, after correction for multiple sites within the mouth (using the
DESCRIPT procedure in SUDAAN 7.0), according to DUBEY et al. (14).
**When the global P-value is significant, paired comparisons were performed using chi-square analysis, corrected for complex sampling;
the symbol ‘6¼’ indicates significantly (P<0.05) dierent groups.
4Bourgeois et al.
Discussion
To the best of our knowledge, the present study is the
first randomized clinical trial based on the CONSORT
statement (11, 20) that describes the eciency of inter-
dental calibrated brushes on interproximal bleeding in
healthy periodontal adults.
The first objective of our study was to examine
whether CPS interdental calibrated brushes are eective
in reducing the frequency of interproximal bleeding
when used with regular toothbrushing. A potential limi-
tation of this study was the absence of a group using
dental floss or other IDBs. In the literature, the quality
of the only published study comparing toothbrushing
plus interdental brushing with toothbrushing alone is
considered low (3). Only one study, which had a high
risk of bias, has compared interdental brushing and
toothbrushing with toothbrushing alone (21). There is
no agreed-upon scientific method for choosing IDBs
(5). The so-called reference technique is the empirical
subjective method in everyday use. This technique con-
sists of testing the various IDBs in order of increasing
diameter. The use of colorimetric probes and interden-
tal brushing in our study was more beneficial than
interdental brushing alone and can be considered a new
technique for increasing the concordance between the
empirical choice of IDBs of dierent diameters and the
gold standard (5).
This explanatory randomized control study provide
information on whether the intervention is eective
under optimal conditions, including strict eligibility
criteria, compliant subjects, maximum monitoring of
practitioner adherence to the study protocol, and for-
mal follow-up visits (22). With respect to such criteria,
volunteers of the Faculty of Oral Medicine University
dier from many other groups in society in a number
of ways, which has implications for the generalizability
of the results (external validity). However, the quality
of the results in an explanatory approach is not
aected.
Regarding the sampling method, there are several
important points to consider. First, the analysis is per-
formed on all interdental sites using the SUDAAN pro-
gram, which allows for adjustment of the P-values and
standard errors from clustering (i.e. multiple sites
within the mouth). Second, to achieve correct random-
ization in the two groups, balanced selection was used
in terms of sex and baseline bleeding, as described in
the Material and Methods. Therefore, the allocation
has been made without any bias. Bleeding on IBD pres-
sure was used as the dependent variable. According to
LORENZ et al., there is no doubt that indices containing
a bleeding component can successfully be used in clini-
cal trials (23). However, the reproducibility of the diag-
nosis of bleeding has been widely discussed in the
literature (24). The force applied to the IDB, the angle
of insertion, and the experience of the examiner are
cited as factors of misdiagnosis. The bleeding index can
also be influenced by the initial oral hygiene standard
of the participants (25). Therefore, participants were
stratified according to the baseline levels of bleeding to
ensure equal distribution.
The internal validity of the study was guaranteed
using a calibration process. The two examiners who
participated in data collection were previously trained
in a calibration workshop. The same examiners had
participated in a previous study using a similar proto-
col. The blinding of the examiners was guaranteed
throughout the study. None of the participants in either
group dropped out of the study, which was certainly
because of the specific characteristics of the sample.
An interesting issue is the association of bleeding
with the need for periodontal care in the medium and
long term. Gingivitis is a reversible condition associated
with bacterial biofilms; it generally resolves clinically
within approximately 1 wk after the reinstitution of
oral-hygiene procedures (26). It could be easily argued
that the natural occurrence of gingival inflammation
describes a condition whose characteristics are normally
distributed in the population (27). The reduction of gin-
givitis in the general population results in more than
merely cosmetic improvement following the reduction
of gingival bleeding. However, there is overwhelming
evidence that gingivitis is linked to periodontitis, and
the elimination of gingivitis will result in the reduction
of attachment loss in the majority of the population
(28).
Adherence to daily dental flossing is low among
patients because it requires a certain degree of dexterity
Table 3
Multivariate associations* between studied variables and
bleeding at 3 months after interproximal brushing
(n=1,108
sites from 46 subjects)
Variable nOR (95% CI) P
Participant-level variables
Group
Control (no interproximal
brushing)
540 4.3 (1.612.1) 0.006
Test (interproximal brushing) 568 1
Baseline bleeding risk
High 526 2.3 (0.95.5) 0.065
Low 582 1
Site-level variables
Zone
Posterior 750 2.2 (1.53.3) <0.001
Anterior 358 1
Interproximal brush at 3 months
5 (1.1 mm) 112 0.0 (0.00.2) 0.005
4 (0.9 mm) 159 0.1 (0.00.5)
3 (0.8 mm) 251 0.5 (0.31.1)
2 (0.7 mm) 405 0.6 (0.31.0)
1 (0.6 mm) 181 1
*Backward stepwise based on statistical significance (P>0.15 to
exclude a variable). Initial variables included also age, sex, and
smoking status. Values of Pand 95% CI were calculated using
LOGISTIC PROC in SUDAAN 7.0, to account for clustering
(multiple sites within patients).
These data refer to 46 patients 930 sites/patient =1,380 sites;
sites were excluded owing to presence of diasthema (n=21), lack
of tooth (n=163), or lack of space to introduce the interproximal
brush during the follow up (n=80); thus, available sites for this
table =1,167.
Interdental brushing and bleeding 5
and motivation (29); patients prefer IDBs because they
are easier to use (4, 30). Furthermore, when compared
with dental floss, IDBs are thought to be more eective
for plaque removal because the bristles fill the embra-
sure and are able to clean the invaginated areas on the
tooth and root surfaces (9). In addition, dental floss
does not reach the anatomical concavities of the proxi-
mal surfaces of premolars and molars, which renders
the flossing eort incomplete (31).
Our findings suggest a positive impact of the use
of IDBs in reducing interproximal bleeding of peri-
odontally healthy young participants. From week 1,
the observed reduction was 47% compared with the
control. At 3 months, bleeding was reduced by 71%.
No undesired side eects from using IDBs were
observed over the 3-month study period. These find-
ings need to be confirmed over a longer time period
and the intervention should be compared, in clinical
trials, with other methods of interdental brushing,
such as dental floss and dental sticks of dierent
kinds.
The study findings oer evidence of the eectiveness
of a programme for reducing bleeding through daily
IDB use in young adults. The attendance rate for the
intervention sessions was high because the participants
were from the Faculty of Oral Medicine. While these
results may support the feasibility of a population
approach to promoting dental health through interden-
tal brushing coaching programmes, it is still necessary
to evaluate the eectiveness of the procedure in real-life
conditions.
Conflict of interest – The authors declare that they have no con-
flicts of interest related to this study.
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6Bourgeois et al.
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... 24 Daily use of interdental brushes was found to reduce interdental bleeding thus implying that interdental cleaning is an effective means of achieving optimal oral health. 25 Interdental toothbrushes are reported to be more efficacious in interdental supra-gingival plaque removal than dental floss in periodontal maintenance care individuals. 26 Oral irrigators combined with manual toothbrushing daily significantly reduces gingival bleeding scores when compared to the use of dental floss only. ...
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Chapter
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Thesis
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To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Article
Effective oral hygiene is a crucial factor in maintaining good oral health, which is associated with overall health and health-related quality of life. Dental floss has been used for many years in conjunction with toothbrushing for removing dental plaque in between teeth, however, interdental brushes have been developed which many people find easier to use than floss, providing there is sufficient space between the teeth. To evaluate the effects of interdental brushing in addition to toothbrushing, as compared with toothbrushing alone or toothbrushing and flossing for the prevention and control of periodontal diseases, dental plaque and dental caries. We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 7 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 2), MEDLINE via OVID (1946 to 7 March 2013), EMBASE via OVID (1980 to 7 March 2013), CINAHL via EBSCO (1980 to 7 March 2013), LILACS via BIREME (1982 to 7 March 2013), ZETOC Conference Proceedings (1980 to 7 March 2013) and Web of Science Conference Proceedings (1990 to 7 March 2013). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) for ongoing trials to 7 March 2013. No restrictions were placed on the language or date of publication when searching the electronic databases. We included randomised controlled trials (including split-mouth design, cross-over and cluster-randomised trials) of dentate adult patients. The interventions were a combination of toothbrushing and any interdental brushing procedure compared with toothbrushing only or toothbrushing and flossing. At least two review authors assessed each of the included studies to confirm eligibility, assessed risk of bias and extracted data using a piloted data extraction form. We calculated standardised mean difference (SMD) and 95% confidence interval (CI) for continuous outcomes where different scales were used to assess an outcome. We attempted to extract data on adverse effects of interventions. Where data were missing or unclear we attempted to contact study authors to obtain further information. There were seven studies (total 354 participants analysed) included in this review. We assessed one study as being low, three studies as being high and three studies as being at unclear risk of bias. Studies only reported the clinical outcome gingivitis and plaque data, with no studies providing data on many of the outcomes: periodontitis, caries, halitosis and quality of life. Three studies reported that no adverse events were observed or reported during the study. Two other studies provided some data on adverse events but we were unable to pool the data due to lack of detail. Two studies did not report whether adverse events occurred. Interdental brushing in addition to toothbrushing, as compared with toothbrushing alone Only one high risk of bias study (62 participants in analysis) looked at this comparison and there was very low-quality evidence for a reduction in gingivitis (0 to 4 scale, mean in control): mean difference (MD) 0.53 (95% CI 0.23 to 0.83) and plaque (0 to 5 scale): MD 0.95 (95% CI 0.56 to 1.34) at one month, favouring of use of interdental brushes. This represents a 34% reduction in gingivitis and a 32% reduction in plaque. Interdental brushing in addition to toothbrushing, as compared with toothbrushing and flossing Seven studies provided data showing a reduction in gingivitis in favour of interdental brushing at one month: SMD -0.53 (95% CI -0.81 to -0.24, seven studies, 326 participants, low-quality evidence). This translates to a 52% reduction in gingivitis (Eastman Bleeding Index). Although a high effect size in the same direction was observed at three months (SMD -1.98, 95% CI -5.42 to 1.47, two studies, 107 participants, very low quality), the confidence interval was wide and did not exclude the possibility of no difference. There was insufficient evidence to claim a benefit for either interdental brushing or flossing for reducing plaque (SMD at one month 0.10, 95% CI -0.13 to 0.33, seven studies, 326 participants, low-quality evidence) and insufficient evidence at three months (SMD -2.14, 95% CI -5.25 to 0.97, two studies, 107 participants very low-quality evidence). Only one study looked at whether toothbrushing with interdental brushing was better than toothbrushing alone, and there was very low-quality evidence for a reduction in gingivitis and plaque at one month. There is also low-quality evidence from seven studies that interdental brushing reduces gingivitis when compared with flossing, but these results were only found at one month. There was insufficient evidence to determine whether interdental brushing reduced or increased levels of plaque when compared to flossing.
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To cite this article: Int J Dent Hygiene9, 2011; 211–215 DOI: 10.1111/j.1601-5037.2010.00483.x Hofer D, Sahrmann P, Attin T, Schmidlin PR. Comparison of marginal bleeding using a periodontal probe or an interdental brush as indicators of gingivitis. Aim: To compare the use of interdental brushes to a periodontal probe in assessing marginal bleeding, in natural gingivitis. Materials and methods: Sixty-four consecutive volunteers presenting with gingival inflammation were recruited at their semi-annual recall appointments for this study. All had ≥50% papillary height and no pocketing that exceeded 4 mm. Contra-lateral quadrants (1 & 3 or 2 & 4) were randomly tested for bleeding with one pass-through with an interdental brush or with a periodontal probe inserted 2 mm into the gingival sulcus. The presence or absence of both bleeding and plaque were then recorded. Correlation coefficients were calculated for the interdental brushes and the periodontal probe, and the plaque and bleeding scores. Results: The periodontal probe and the interdental brushes showed mean average bleeding scores of 47.39% and 45.74% respectively. The correlation coefficient for the two methods was 0.73 (P < 0.0001). No correlation between plaque and bleeding was found. Conclusions: Interdental brushes can be considered a valid alternative to a periodontal probe in assessing marginal bleeding in gingivitis patients. An interdental brush, sized correctly for each interdental space, is easy to handle, atraumatic to the papillae and will allow gingivitis patients to monitor their own progress, while at the same time performing a beneficial oral hygiene procedure and removing any interdental plaque present.