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UvA-DARE is a service provided by the library of the University of Amsterdam (http://dare.uva.nl) UvA-DARE (Digital Academic Repository) Prevention of gingival trauma Hennequin-Hoenderdos, N.L. Link to publication Citation for published version (APA): Hoenderdos, N. L. (2017). Prevention of gingival trauma: Oral hygiene devices and oral piercings DIDES General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. Download date: 28 Jun 2018
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UvA-DARE is a service provided by the library of the University of Amsterdam (http://dare.uva.nl)

UvA-DARE (Digital Academic Repository)

Prevention of gingival trauma

Hennequin-Hoenderdos, N.L.

Link to publication

Citation for published version (APA):Hoenderdos, N. L. (2017). Prevention of gingival trauma: Oral hygiene devices and oral piercings DIDES

General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s),other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons).

Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, statingyour reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Askthe Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam,The Netherlands. You will be contacted as soon as possible.

Download date: 28 Jun 2018

3

The eff ect of tapered toothbrush fi laments compared to end-rounded fi laments on dental

plaque, gingivitis and gingival abrasion: a systematic review

and meta-analysis

FCR HoogteijlingNL Hennequin-HoenderdosGA van der WeijdenDE Slot

International Journal of Dental Hygiene 2017 Early view

Chapter 3

44

Abstract

AimThis systematic review was performed to establish the effect of a manual toothbrush with tapered toothbrush filaments (TFTBs) compared to a manual toothbrush with end-rounded toothbrush filaments (ERTB) on clinical parameters of dental plaque, gingivitis and gingival abrasion.

Materials and methodsMEDLINE-PubMed and Cochrane-CENTRAL databases were searched. The inclusion criteria were (randomized) controlled clinical trials, participants ≥18 years and papers evaluating the effect of a TFTB compared to an ERTB. Data were extracted for dental plaque index (PI), bleeding scores (BS), gingival index scores (GI) and gingival abrasion scores (GA). A descriptive analysis and a meta-analysis were performed when appropri-ate.

ResultsAn independent screening of 33 unique papers resulted in seven eligible publications, which included eight comparisons. Meta-analysis did not show a significant difference between TFTB and ERTB with respect to PI scores. The meta-analysis of the GI scores showed a significant mean difference in favour of the TFTB (DiffM=−0.12 [95% CI: −0.17; −0.07]). Of the three comparisons evaluating GA, no differences were found.

ConclusionWith respect to plaque removal, evidence that supports the recommendation for usage of a TFTB over an ERTB is lacking. Regarding GI, there is minimal evidence favouring a TFTB over an ERTB and the clinical relevance of this difference is probably negligible. Therefore, based on the collective evidence emerging from this systematic review, the strength and direction of the recommendation, there appears to be no firm evidence for a dental healthcare professional to advise the use of a TFTB over the use of an ERTB.

Tapered filaments

45

3

Introduction

It is well known that dental plaque on teeth and gingival surfaces eventually leads to gingival inflammation1. Therefore, effective plaque removal is most important for maintaining and improving dental health. Gingivitis can primarily be prevented by the daily use of a toothbrush with an adequate brushing technique. Many variations of manual toothbrushes are currently available on the market with the claim that they are effective for plaque removal and safe for use2. Brush head and filament shapes and even the placement of the filaments in the handle are the subjects of new improve-ments3,4. Ever since the introduction of nylon filaments in the 1930s, much imagination and inventiveness has been applied to toothbrush design. The number and length of filaments in a tuft, the number of tufts and the arrangement of tufts are aspects that may vary with toothbrush filament designs5.Manufacturers claim their own specific specialty in numerous surveys for each new designed toothbrush4. The American Dental Association (ADA) recommends that the toothbrush bristle ends be “free of sharp or jagged edges and endpoints” to minimize gingival and dental abrasions6. Consequently, most manual toothbrushes have conical or end-rounded filaments. The latest development is a manual toothbrush with tapered toothbrush filaments (TFTBs) originally produced by toothbrush manufacturers from Asia. Those manufacturers that produce toothbrushes with tapered filaments claim better plaque removal, which can result in increased gingival health and a decrease in potential gingival tissue trauma compared to toothbrushes with end-rounded filaments. A systematic review evaluating the efficacy of a tapered filament toothbrush (TFTB) on the parameters of dental plaque index scores (PI), gingival health (bleeding scores (BS), gingivitis index (GI)) and gingival abrasion (GA) is currently not available. Thus, the aim of this article was to systematically collect and appraise the scientific evidence that as-sesses the effect of a manual toothbrush with tapered filaments compared to a manual toothbrush with end-rounded filaments on the clinical parameters of plaque, gingivitis and GAs.

Materials and methods

This systematic review was prepared and described in accordance with the Cochrane Handbook7 for Systematic Reviews of Interventions, which provides guidance for the preparations, and the guidelines of Transparent Reporting of Systematic Reviews and Meta-analyses (PRISMA statement)8,9. The protocol that details the review method was developed “a priori” following an initial discussion among the members of the research team.

Chapter 3

46

Focused questionBased on the outcome of Randomized Controlled Clinical Trials (RCT), what is the sum-marized effect of a manual toothbrush with tapered filaments compared to a flat-trim manual toothbrush with end-rounded filaments on the clinical parameters of plaque, gingivitis and gingival abrasion?

Search strategyInternet sources were used to search for appropriate papers that satisfied the study purpose. These sources included the National Library of Medicine, Washington, D.C. (MEDLINE-PubMed) and the Cochrane Central Register of Controlled Trials (CENTRAL). A comprehensive search of the databases was conducted through October 2016 for appropriate studies regarding the focused question. All references cited in the included trials were checked for additional studies. Hand searching was performed as part of the Cochrane Worldwide Hand Searching Programme and uploaded to CENTRAL. Ad-ditionally, the manufacturer of the Meridol toothbrush (GABA/Colgate in Switzerland) was contacted for unpublished data. The structured search strategy was designed to include any relevant published papers that evaluated the adjunctive effect of a manual toothbrush with tapered filaments vs the end-rounded manual toothbrush. For details regarding the search terms used, see Box 1.

box 1. Search strategySearch terms used for PubMed-MEDLINE and Cochrane-CENTRAL are shown. The search strategywas customized according to the database being searched.The following strategy was used in the search:{ (Intervention) AND (Specific characteristics) }{<Toothbrush: [MeSH terms /all subheadings] Toothbrushing OR [textwords] Toothbrush* OR Toothbrush >AND<Filament design: Tapered OR Conical OR (Needle shaped) OR (ultra thin) OR Pointed OR lessened OR narrowed >}The asterisk (*) was used as a truncation symbol.

Screening and selectionTitles and abstracts of studies obtained from the searches were independently screened by two reviewers (FH and DES) and were categorized as definitely eligible, definitely not eligible or questionable. The reviewers were not blinded to names of authors or institutions and journals while making the assessment.

Tapered filaments

47

3

The eligibility criteria were as follows:– RCTs– Papers written in the English language– Studies conducted on humans

• ≥18yearsold

• Ingoodgeneralhealth

• Participantbrushing

– Intervention: a TFTB– Comparison: a ERTB– Evaluation with one or more of the following clinical evaluation parameters: PI, BS,

GI and GA.

If eligible aspects were present in the title, the paper was selected for further reading. If none of these aspects were mentioned in the title, the abstract was read in detail to screen for suitability. Papers that potentially would meet the inclusion criteria were obtained and read in detail by the two reviewers (FH and DES). Disagreements in the screening and selection process concerning eligibility were resolved by consensus or, if disagreement persisted, by arbitration through a third reviewer (GAW). The papers that fulfilled all of the inclusion criteria were processed for data extraction.

Assessment of heterogeneityThe heterogeneity of the primary outcome parameters across studies was detailed according to the following factors:– Study design, research groups and evaluation period– Intervention: type of manual toothbrushes and procedures– Industry funding and side effects

Quality assessmentTwo reviewers (FH and DES) scored the methodological qualities of the included studies according to the method described in detail by Keukenmeester et al. (2013)10 In short, when random allocation, defined eligibility criteria, masking of examiners, masking of patients, balanced experimental groups, identical treatment between groups (except for the intervention) and reporting of follow-up were present, the study was classified as having an estimated low risk of bias. When one of these criteria was missing, the study was considered to have an estimated moderate risk of bias. When two or more of these criteria were missing, the study was estimated to have a high risk of bias, as previously proposed by Van der Weijden et al. (2009)11.

Chapter 3

48

Statistical analysesData extractionThe data from the papers that met selection criteria were extracted and processed for further analysis. Two reviewers (FH and DES) evaluated the selected papers for mean baseline and end trial values and standard deviation (SD). For studies that presented an intermediate outcome assessment, only the baseline and final evaluations were used. Disagreements were resolved by discussion and, if the disagreement persisted, the judgement of a third reviewer (GAW) was decisive.

Data analysisAs a summary, a descriptive data presentation was used for all studies. For studies that had multiple treatment arms and for which data from the control group were com-pared with more than one other group, the number of subjects (n) in the control group was divided by the number of comparisons. The primary variable of interest was PI. The secondary variables were BS, GI and GA. When appropriate, a meta-analysis was per-formed, and the DiffM was calculated using the Review Manager 5.1 software (RevMan version 5.1 for Windows, Copenhagen: The Nordic Cochrane Centre, The Cochrane Col-laboration, 2011). Primarily the random effects model was used to calculate a weighted average of the treatment effects across the studies under review. If fewer than four studies were included, a fixed-effect analysis was used as the estimate of between-study variance7. Heterogeneity was tested by the chi-square test and the I2 statistics.

Grading the body of evidenceThe Grading of Recommendations Assessment, Development and Evaluation system, as proposed by the GRADE working group, was used to rank and grade the evidence emerging from this review12,13. Only for the outcome parameters, for which a meta-analysis was applicable, a GRADE evidence profile was performed. Two reviewers (GAW and DES) rated the quality of the evidence as well as the strength and direction of the recommendations according to the following aspects: risk of bias of the individual studies; consistency and precision among the study outcomes; directness of the study results; and detection of publication bias. Any disagreement between the two review-ers was resolved after additional discussion.

Results

Search & selection resultsThe databases searches resulted in 33 unique papers (for details, see Figure 1). The screen-ing of titles and abstracts resulted in six papers14-19 that were eligible for inclusion in this

Tapered filaments

49

3

systematic review according to defined criteria for study design, participants, interven-tion and outcome. Hand searching of the reference lists did reveal one additional suitable paper by Checchi et al. (2007)20. A total of seven papers presented eight comparisons.

FIGuRe 1. Search and selection results.

Chapter 3

50

TAb

le 1

. O

verv

iew

of t

he in

clud

ed s

tudi

es a

nd c

hara

cter

isti

cs p

roce

ssed

for d

ata

extr

acti

on.

# Aut

hors

(yea

r)

Stud

y de

sign

, du

rati

onbl

indi

ngO

ral p

roph

ylax

is

(OP)

# Pa

rtic

ipan

ts

base

line

(end

)G

ende

rM

ean

age

Age

rang

e in

yea

rs

Gro

ups

(bra

nd)

TFT b

: tap

ered

fila

men

ts to

othb

rush

eRTb

: end

roun

ded

toot

hbru

shTo

othp

aste

Regi

men

:u

se &

inst

ruct

ion

Fund

ing

Conc

lusi

ons

of th

e or

igin

al

auth

ors

I Dör

fer

et a

l. 20

0314

RCT

Split

mou

thSi

ngle

use

Sing

le b

lind

OP:

No

87 (8

7)♀

: 0♂

: 87

(87)

Mea

n ag

e: 2

7Ag

e ra

nge:

18-

63

TFTB

: Mer

idol

GA

BA C

HER

TB: fl

at-t

rim m

anua

l too

thbr

ush

(AD

A

refe

renc

e to

othb

rush

)D

F: S

tand

ard

fluor

ide

dent

ifric

e Bl

end

a m

ed

clas

sic,

Pro

cter

& G

ambl

eFo

r 12-

day

accl

imat

izat

ion

perio

d

12-d

ay a

cclim

atiz

atio

n pe

riod

Brus

h on

alte

rnat

e da

ys w

ith th

e to

othb

rush

esSu

perv

ised

bru

shin

g w

ithou

t DF

30 s

econ

ds p

er q

uadr

ant

Fund

ing:

GA

BA C

H

The

TFTB

was

sta

tistic

ally

m

ore

sign

ifica

nt o

n th

e ov

eral

l pla

que

redu

ctio

n an

d th

e re

mai

ning

pla

que

than

the

ERTB

.

II Sgan

-Coh

enet

al.

2005

15

RCT

Para

llel

60 d

ays

Sing

le b

lind

OP:

Yes

70 (6

8)♀

: 40

♂: 3

0M

ean

age:

36◊

Age

rang

e: ?

TFTB

: Mer

idol

, GA

BA C

HER

TB: fl

at-t

rim m

anua

l too

thbr

ush

(AD

A

refe

renc

e to

othb

rush

)D

F: s

tand

ard

dent

ifric

e

Ora

l pro

phyl

axis

took

pla

ce 7

-10

days

prio

r bas

elin

eBr

ush

2x d

aily

Fund

ing:

GA

BA C

H

Ther

e w

as n

o si

gnifi

cant

di

ffere

nce

betw

een

the

TFTB

and

the

ERTB

.

III Ren

et a

l. 20

0716

RCT

Para

llel

30 d

ays

Sing

le b

lind

OP:

No

? (5

7◊)

♀: 4

8♂

: 42

Mea

n ag

e: 3

3Ag

e ra

nge:

?

TFTB

A: E

SES

Elm

ex s

ensi

tive

extr

a so

ft, G

ABA

CH ER

TB: s

tand

ard

flat-

trim

man

ual t

ooth

brus

h (A

DA

refe

renc

e to

othb

rush

)D

F: S

tand

ard

fluor

ide

dent

ifric

e(C

olga

te C

avity

Pro

tect

ion)

Was

hout

per

iod

of 7

day

sBr

ush

2x d

aily

in u

sual

man

ner

Fund

ing:

Stip

end

from

GA

BA C

H

The

TFTB

was

sig

nific

antly

m

ore

effec

tive

in

rem

ovin

g de

ntal

pla

que

and

redu

cing

gin

giva

l in

flam

mat

ion

inte

rpro

xim

al

than

the

ERTB

.

IV Vers

teeg

et a

l. 20

0817

RCT

Split

-mou

th30

day

sEx

perim

enta

l gi

ngiv

itis

stud

ySi

ngle

blin

dO

P: Y

es

35 (3

2)♀

: 23

♂: 9

Mea

n ag

e: 2

4Ag

e ra

nge:

21-

42

TFTB

: Mer

idol

, GA

BA C

HER

TB: fl

at-t

rim m

anua

l too

thbr

ush

(AD

A

refe

renc

e to

othb

rush

)D

F: S

tand

ard

dent

ifric

e (E

verc

lean

, HEM

A, T

he

Net

herla

nds)

Fam

iliar

izat

ion

phas

e of

14

days

: br

ush

2x d

aily

for 2

min

utes

, “Ba

ss”

met

hod

Trea

tmen

t pha

se: s

plit-

mou

th b

oth

brus

hes

1 m

inut

eFu

ndin

g: G

ABA

CH

Both

toot

hbru

shes

im

prov

ed g

ingi

val h

ealth

an

d eff

ectiv

ely

rem

oved

pl

aque

.

Tapered filaments

51

3

# Aut

hors

(yea

r)

Stud

y de

sign

, du

rati

onbl

indi

ngO

ral p

roph

ylax

is

(OP)

# Pa

rtic

ipan

ts

base

line

(end

)G

ende

rM

ean

age

Age

rang

e in

yea

rs

Gro

ups

(bra

nd)

TFT b

: tap

ered

fila

men

ts to

othb

rush

eRTb

: end

roun

ded

toot

hbru

shTo

othp

aste

Regi

men

:u

se &

inst

ruct

ion

Fund

ing

Conc

lusi

ons

of th

e or

igin

al

auth

ors

V Chec

chi

et a

l. 20

0720

RCT

Para

llel

6 m

onth

sSi

ngle

blin

dO

P: Y

es

30 (3

0)♀

: 15

♂: 1

5M

ean

age:

22◊

Age

rang

e: ?

TFTB

: Mer

idol

, GA

BA C

HER

TB: fl

at-t

rim m

anua

l too

thbr

ush

(AD

A

refe

renc

e to

othb

rush

)D

F: s

tand

ard

toot

hpas

te

No

fam

iliar

izat

ion

phas

eBr

ush

2x d

aily

for 2

min

utes

, “Ba

ss

met

hod”

Fund

ing:

GA

BA C

H

For t

he p

laqu

e in

dex

and

ging

ival

inde

x,

impr

ovem

ent w

as s

how

n in

bot

h gr

oups

, but

mor

e re

leva

nt in

bot

h ta

pere

d te

st g

roup

s.

VI Sgan

-Coh

enet

al.

2008

18

RCT

Para

llel

60 d

ays

Sing

le b

lind

OP:

Yes

120

(107

)♀

: ?♂

: ?M

ean

age:

45◊

Age

rang

e: 3

0-?

TFTB

: ESE

S El

mex

sen

sitiv

e ex

tra

soft

, GA

BA

CH ERTB

: flat

-trim

man

ual t

ooth

brus

h (A

DA

re

fere

nce

toot

hbru

sh)

DF:

Elm

ex s

ensi

tive

toot

hpas

te, G

ABA

CH

Fam

iliar

izat

ion

phas

e of

14

days

Brus

h 2x

dai

ly, n

o or

al h

ygie

ne

inst

ruct

ions

Fund

ing:

GA

BA C

H

For a

ll th

ree

inde

x co

mpo

nent

s (p

laqu

e,

blee

ding

, GI),

the

leve

l at

two

mon

ths

is lo

wer

th

an b

asel

ine

for t

he T

FTB

grou

p.

VII

Capo

ross

i et a

l. 20

1619

RCT

Split

mou

thCr

oss

over

Sing

le u

seSi

ngle

blin

dO

P: Y

es

39 (3

9)♀

: 21

♂: 1

8M

ean

age:

24

Age

rang

e: ?

TFTB

: Col

gate

360

Dee

p Cl

ean,

Sao

Ber

nard

o do

Cam

po, B

razi

lER

TB: O

ral-B

Indi

cato

r Plu

s, si

ze 3

5, G

ross

-G

erau

, Ger

man

yD

F: O

ral -

B pr

o Sa

ude,

Pro

cter

& G

ambl

e,

Gro

ss-G

erau

, Ger

man

y

Fam

iliar

izat

ion

phas

e of

10

days

: on

alte

rnat

e da

ys w

ith th

e to

othb

rush

esbr

ush

2x d

aily

“Bas

s m

etho

d”Br

ush:

sin

gle

use,

30

seco

nds

per

quad

rant

Fund

ing:

?

End

roun

ded

bris

tles

rem

oved

pla

que

mor

e eff

ectiv

ely

with

out c

ausi

ng

a hi

gher

inci

denc

e of

gi

ngiv

al a

bras

ion

whe

n co

mpa

red

with

tape

red

bris

tles.

ERTB

, end

-rou

nded

toot

hbru

sh; T

FTB,

tape

red

filam

ent t

ooth

brus

h; D

F, de

ntifr

ice;

♀, f

emal

e; ♂

, mal

e; N

A, n

ot a

pplic

able

; OP,

oral

pro

phyl

axis

; ◊, c

alcu

late

d by

the

auth

ors

of th

is re

view

bas

ed o

n th

e pr

esen

ted

data

in th

e se

lect

ed p

aper

.

Chapter 3

52

Assessment of heterogeneityConsiderable heterogeneity was observed in the seven clinical trials with respect to study design, evaluation period, study population, number, gender and age of partici-pants. Information regarding the study characteristics is displayed in detail in Table 1. Various clinical indices and their modifications were used.

Study design, research groups and evaluation periodAll included studies were RCTs. Six studies used a parallel design (I, II, III, IV, V and VI), of which one used an experimental gingivitis model (IV). Three studies used a split-mouth design (studies I, IV and VII) of which one (VII) used a cross over design. The approximate mean age of the included participants was 30 years. All the studies excluded participants with periodontitis. In study I, no females were included. The evaluation period varied from single use (I and VII), 30 days (III and IV), 60 days (II and VI) and 6 months (V). Procedures for allocation concealment were not described in any of the selected studies with the excep-tion of study IV. Masking (blinding) of the examiner was described in all studies. Blinding of the participant is difficult as the filament design is visible for participants. Nevertheless, one study (VI) mentioned double-blinding. In this study and study III, participants were not informed if they were assigned a test or control toothbrush.

Intervention: type of manual toothbrush and proceduresStudies mentioned a washout period of 7 days (III), a familiarization phase of 10 days (VII) or 14 days (IV and VI) or an acclimatization period of 12 days (I) prior baseline measurements. Five studies (II, IV, V, VI and VII) provided oral prophylaxis before the start of the study. A period of non-brushing before measurements was reported: 2-3 hours (IV), 48 hours (I), ≥12 hours (II and III, VI) and 72 hours (VII). In one study, it was unclear how many hours participants brushed prior the measurements (V). All papers that were identified, used toothbrushes from one and the same manufacturer (Colgate-GABA) however under different brands names. For details, see Table 1. In all studies, par-ticipants brushed with dentifrice during the course of the study. One study mentioned that no dentifrice was used during the brushing procedure (I). Another study used a split-mouth design to brush with dentifrice or water with both toothbrushes (VII).

Industry funding & side effectsAll but one (VII) of the selected studies were supported by GABA International, which is now part of Colgate Palmolive. Further details explaining what this support implied were not given. All authors were affiliated academics, although only one (VII) mentioned disclosure or statement of any conflict of (financial) interest. The majority of papers did not report any adverse events during the follow-up period. However, Dörfer et al. (2003) (I) observed one case in which, after toothbrushing, a small GA was observed on the

Tapered filaments

53

3

palatal mucosa between the two middle incisors (papilla incisiva). It was not possible for these authors to determine which brush, TFTB or end-rounded toothbrush filaments (ERTB), caused the abrasion.

Quality assessmentThe quality assessment items, including external, internal and statistical validity are presented in the Appendix S1. Based on a summary of these criteria, the estimated potential risk of bias is low in all studies. Because less than 10 studies were included in the meta-analysis7 ,the formal testing for publication bias that was proposed by Egger et al. (1997)21 could not be used owing to insufficient statistical power.

Results of study outcomesThe Appendix S2 (a-d) shows the results from the data extraction. In the current review, different indices and their modifications were used. Information regarding the changes within each intervention group for the various indices was also presented.

Between groupsTable 2 presents the descriptive analysis. In general, the overall descriptive analyses for PI showed three comparisons in favour of the TFTB and three in favour of the ERTB. Two comparisons resulted in no difference. Regarding GI, two of three experiments showed a positive significant effect towards the TFTB. For BS, one comparison showed a significant effect for the ERTB and one comparison found no difference between the two toothbrushes. The three comparisons (17, 2×19) that evaluated the parameter of GA showed that there is no difference between the TFTB and the ERTB. One experiment also evaluated the effect of both toothbrushes with and without dentifrice. No differ-ence in the incidence of GA was detected between the toothbrushes when used with dentifrice nor with water.

Meta-analysisOnly the available data for PI by the use of the Quigley & Hein22 and GI by Löe & Sillness23 were amenable to meta-analysis (MA). Some studies could not be included in the MA due to the use of incompatible indices. None of the MA at baseline showed a significant difference between the groups (Appendix S3 a & b). Table 3 shows the MA for outcome measures as end scores and reveals a significant effect favouring the use of the TFTB for GI23 (difference in means, DiffM=−0.12; P=.00001; 95% CI:[ −0.17; −0,07]. No significant difference between TFTB and ERTB on PI22 was observed (DiffM=0.10; P=0.41; 95% CI:[ −0.13,0.32].

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TAble 2. A descriptive summary of the comparison and intervention indicating whether there is a significant difference post-brushing between the intervention and comparison.

Study # Intervention PI GI bS GA Comparison

IDörfer et al. 200314

TFTB + no DF O o o o ERTB + no DF

IISgan-Cohen et al. 200515

TFTB + DF O O O o ERTB + DF

IIIRen et al. 200716

TFTB-ES + DF + + o o ERTB + DF

IVVersteeg et al. 200817

TFTB + DF - o - O ERTB + DF

VChecchi et al. 200720

TFTB + DF + + o o ERTB + DF

VISgan-Cohen et al. 200818

TFTB-ES + DF + o o o ERTB + DF

VIICaporossi et al. 201619

TFTB + DF - o o O ERTB + DF

TFTB + water - o o O ERTB + water

PI, plaque index; GI; gingival index; GA, gingival abrasion; ERTB, end-rounded toothbrush; TFTB, tapered filament toothbrush; TFTB-ES, tapered filament toothbrush extra soft; O, no difference; +, significant differ-ence in favour of intervention; −, significant difference in favour of comparison; o, no data available; DF, dentifrice.

TAble 3. Meta-analysis for the end scores of the primary outcome parameters of interest (PI and GI).

Index StudiesMeasure-ment Model DiffM

Test for overallTest for heterogeneity

95% CI p-value I2 value (%)

p-value

PI I Dörfer 200314

III Ren 200716

IV Versteeg 200817

VII Caporossi et al. 2016(2x)19

Baseline Random 0.02 [-0.08; 0.11] 0.73 0% 1.00

End Random 0.10 [-0.13; 0.32] 0.41 85% <0.0001

Difference Random 0.07 [-0.18; 0.32] 0.59 89% <0.00001

GI II Sgan-Cohen 200515

III Ren 200716

V Checchi 200720

Baseline Fixed -0.06 [-0.12; 0.00] 0.06 31% 0.23

End Fixed -0.12 [-0.17; -0.07] 0.00001 68% 0.04

Difference Fixed -0.06 [-0.10; -0.02] 0.005 0% 0.71

A chi-square test resulting in a P<.1 was considered an indication of significant statistical heterogeneity. As a rough guide for assessing the possible magnitude of inconsistency across studies, I2 statistic of 0%-40% was interpreted as not to be imperative, and above 40% indicated that moderate to considerable hetero-geneity was most likely present.

Evidence profileTable 4 shows a summary of the various factors used to rate the quality of evidence and strength and direction of recommendations according to GRADE12,13 including the level of certainty24. A meta-analysis could be performed only for Pl and Gl, and consequently,

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an evidence profile was created. The TFTB studies that were evaluated were from one manufacturer only, which may introduce a publication bias. With respect to PI scores, the strength of the underlying evidence was estimated to be low. Given that the meta-analysis provides no evidence supporting that the TFTB removes dental plaque better than an ERTB, the direction of the recommendation is that currently, no preference for the TFTB over the ERTB is evident. Concerning the data for the gingival index (GI), the strength of the underlying evidence is moderate. With a small clinical benefit, the direction of the recommendation was therefore weak in favour of the TFTB for reducing gingivitis.

TAble 4. GRADe evidence profile for impact of the use of a tapered filament toothbrush in com-parison with an end-rounded toothbrush on plaque scores and gingival inflammation from the pre-sented systematic review and meta-analysis.

GRADe Plaque index Gingival index

Study design RCT RCT

Studies #Comparisons #

45

33

Risk of bias Low Low

Consistency Inconsistent Consistent

Directness Generalizable Generalizable

Precision Rather imprecise Precise

Publication bias Possible Possible

level of certainty24 Low Moderate

Magnitude of the effect No difference Small

Direction of the recommendation Expert opinion not favouring TFTB over ERTB

Weak certainty favouring TFTB over ERTB

Discussion

Summary of main findingsThis systematic review aimed to determine the clinical efficacy of manual tooth-brushes with different filament designs. Tapered filaments have endings in the shape of an extreme rotational ellipsoid as opposed to end-rounded filaments shaped like a hemisphere. Tapered toothbrushes are processed by chemical agents and not by a grinding machine24. The performance differs from a cylindrical filament in how it bends in response to the load and deflection. A cylindrical filament bends like a beam with little deflection until the load surpasses the cross-sectional strength of the filament. The clinical studies that emerged from the search evaluated the effect of a TFTB and an ERTB on the parameters plaque and gingivitis. A meta-analysis was performed on PI22 and GI23 which showed a statistically significant effect in favour of the TFTB on GI.

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The aim of this study was to systematically collect and appraise the scientific evidence that assesses the effect of a manual toothbrush with tapered filaments compared to a manual toothbrush with end-rounded filaments on the clinical parameters of plaque, gingivitis and GAs. The hypothesis that the use of a manual toothbrush with tapered filaments provides better results than a manual toothbrush with end-rounded fila-ments could not be accepted. The analyses of the current available studies included in this systematic review did not result a thorough conclusion concerning the effects of TFTBs or ERTB.

Strength of evidence for outcomesThe discrepancy between the findings in descriptive summary (Table 2) and the results of the meta-analysis (Table 3) may be clarified by the origin of the analysis itself. The fact that the meta-analysis restricted to the Quigley & Hein22 PI and the Löe & Silness23 GI. While the descriptive analysis is irrespective of the index used in the original study may be of influence. All eight included study comparisons that evaluated dental plaque are presented in the descriptive analysis but only five comparisons could be used in the meta-analysis. All three comparisons evaluating the GI were used in both analysis and are in line with each other. Dental healthcare professionals can advise their patients a toothbrush with TF which is effective in plaque removal and has a small benefit with respect to gingival inflammation over a toothbrush with end-rounded cylindrical fila-ments.

In vitro studiesEspecially for areas that are difficult to access, the filament and bristle design can be important in relation to the efficacy of the toothbrush25. Several in vitro studies have specifically evaluated the efficacy of tapered filaments. In one study, the TFTB was compared with an ADA-referenced brush on artificial plaque removal at the gingival margin and the subgingival area26. The TFTB was found to be more effective. Another in vitro study concluded that a TB with filaments at two different levels with the TF at the high level resulted in a significantly improved removal of the artificial plaque from the interproximal areas27. TF also appear to have an advantage for reaching into the occlusal fissure compared to ER28. All these in vitro findings considered together are in support of the clinical data with respect to TF, although none of the included clinical studies made a separation of scores related to the gingival margin or the approximal areas.

End roundingWith cylindrical filaments, end-rounding is an issue. Using scanning electron micros-copy, a recent evaluation of children’s toothbrushes showed that the percentage

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of acceptable end-rounded bristles ranged from 1.4% to 20.2%29. Therefore, these toothbrushes labelled as end-rounded had the potential to harm oral tissue. Their study demonstrated that quality control for the rounding of bristle ends as well as for the labelling of end-rounded bristles is needed. We recently demonstrated that fila-ments that are not end rounded are more abrasive than partially or fully end-rounded filaments30. In the past, we have also shown that the form of end-rounding had an effect on toothbrush abrasivity. The dome-shaped end-rounding was significantly less abrasive than the pointed type of end-rounding31.Tapered filaments have a cross section that varies along its length with very thin endings. Additionally, these filaments have good stability of the filament corpus14. As a result, more flexibility is introduced in the filaments, which are presumably less harmful14,17. For the present study, only three experiments emerged that assessed GA in relation to TFTBs. One study observed that in comparison to an end-rounded ADA-referenced toothbrush, usage of the TFTB resulted in a tendency towards fewer sites with GA (IV). The other comparison did also not find a statistical difference. The latter was a study with as primary outcome focussed on GA as based on an “a priori” sample size calculation but could not find a difference.

Post-surgical hygiene care and safety for daily useTwo studies recently evaluated the use of a TFTB for post-surgical care compared to the use of an ERTB. Each patient received the assigned toothbrush after periodontal surgery32 or after extraction of a wisdom tooth33. The TFTB showed no adverse effects during wound closure and was preferred by the patients over the ERTB. In the stud-ies included in the present review, patient preference was only described in two of the included studies (II and IV). A higher score was given for “pleasant in use” by those participants using the TFTB. The exact reasons for this preference were not specified in the papers. Because a toothbrush has value in particular if the patient is prepared to use it on a regular basis34, it is important that the patient is satisfied with the recom-mended toothbrush. This will have a positive impact on compliance to oral self-care recommendations.

FundingFor this systematic review, the possibility of publication bias cannot be ruled out because studies were supported or funded by one manufacturer (GABA CH, currently owned by Colgate Palmolive). All participants from all studies used a tapered toothbrush that originated from the same manufacturer. As the funding source is not definitive evidence of bias, it is an indication that for instance reporting bias may exist. Analyses of the methodology of the studies, interpretation of the data and comparison of the products studied can, up to some point, help resolve whether a funding effect exists35.

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Although different study models were used, subanalysis of the data showed that this had no impact on the outcome of the meta-analysis. Additionally, it is relevant to know that the included studies were initiated by the investigator, which limits the influence of the commercial party. The included studies applied internationally agreed models and standards of study design, analysis and reporting and were, therefore, deemed important to accommodate in the systematic review.

Limitations– Blinding of the participant is hardly possible as the filament design being either

tapered or end-rounded is clearly visible. Nevertheless, one study (VI) in this SR reported double-blinding which is interpreted by these authors as not informing the participants whether they were assigned to a test or control toothbrush.

– Although all being categorized as tapered, different TFTB brands were used in the included studies with different toothbrush characteristics, such as extra soft cross-angled filaments (III and VI) and a toothbrush with a raised cleaning tip and soft rubber polishing cups that are made of a synthetic thermoplastic elastomer (VII).

– Brushing duration can influence the efficacy of plaque removal36. This factor was not standardized in all included studies.

– There is cumulative evidence demonstrating that there is moderate certainty that toothbrushing with a dentifrice does not provide an added effect for the mechani-cal removal of dental plaque37. The majority of the comparisons used a dentifrice. One experiment (VII) also evaluated the effect of both test and control toothbrushes with and without dentifrice. Although no difference in the incidence of GA was detected between the toothbrushes, the use of dentifrice resulted in an increase of marginal GA, irrespective of the toothbrush.

Implications for future researchRecently, the new ADA guideline6 on toothbrushes was published, for the design and conduct of clinical studies using manual toothbrushes to provide evidence on safety and effectiveness in reducing gingivitis and removing plaque. Only one (II) of included papers did comply with these guidelines. The majority of the included studies did not fulfil the criteria for instance a minimum of 30 participants per product group and safety assessments that should be continued for a total of 90 days. If researchers are willing to design and conduct a clinical study investigating the safety and effectiveness of manual toothbrushes, it is recommended to adhere to the ADA guidelines. This could improve the quality of individual studies and makes a comparison such as this SR possible. If more studies can be included in SRs and MAs, the level of certainty could be increased.

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Conclusion

With respect to plaque removal, evidence was not conclusive to recommend the TFTB over an ERTB. Regarding GI, a small effect in favour of a TFTB was noted, the clinical relevance of this difference is probably negligible. Therefore, based on the collective evidence emerging from this systematic review, the strength and direction of the recommendation there appears to be no firm evidence for a dental healthcare profes-sional to advise the use of a TFTB over the use of an ERTB.

Clinical relevance

Scientific rationale for the studyManual toothbrushes with TFTB are available on the market. Manufacturers claim that TFTBs have better plaque removal capabilities, which can result in lower bleeding scores and gingival index scores.

Principal findingsNo significant difference in plaque scores was found, while the gingival index scores showed a significant positive effect with unknown clinical relevance.

Practical ImplicationsThe results are applicable for dental healthcare professionals. There is no firm evidence to advise the use of a TFTB over the use of an ERTB.

LimitationThe evaluated TFTBs are from one manufacturer, which might have introduced bias.

Acknowlegdements

The authors of this review are grateful to the following authors for their response, time and effort to search for additional data: Professor Dörfer, Dr. Checchi, Professor Ren, Dr. Rosema and Professor Sgan-Cohen. This article was initiated as a part of the obliga-tion of the first author to fulfil the requirements of the AMC/UvA master’s programme in Evidence-Based Practice; therefore, Erik Bakker is kindly acknowledged for his help preparing the protocol.

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Conflict of interest

The authors declare that they have no conflict of interests. For this study, no funding was accepted, except for support from the listed institutions. Ethical approval was not required. Van der Weijden, Slot and their research team at ACTA have previously received either external advisor fees, lecturer fees or research grants from toothbrush and dentifrice manufacturers. Those manufacturers included Colgate, Dentaid, GABA, Lactona, Oral-B, Procter & Gamble, Sara Lee, Sunstar and Unilever.

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References

* = included publications in this systematic review

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removal efficacy of a manual toothbrush and brushing force. J Clin Periodontol. 1998;25:413–416.

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clinical effectiveness and subjective satisfaction. J Clin Dent. 2005;16:109–113 (Study ID:II).

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cross angled soft bristle design on dental plaque and gingival inflammation: a randomized and

controlled clinical trial. J Dent. 2007;35:614–622 (Study ID:III).

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Supporting information

APPeNDIx S1. Methodological quality and risk of bias scores of the included studies.

StudyQuality criteria I II III IV V VI VII

Internal validity

Random allocation * + + + + + + +

Allocation concealment ? ? ? + ? ? ?

Blinded to patient * NA NA NA NA NA NA NA

Blinded to examiner * + + + + + + +

Blinding during statistical analysis + ? ? + ? ? ?

Balanced experimental groups * + + + + + + +

Reported loss to follow up * + + + + + + +

# (%) of drop-outs #0(0%)

#2(1.4%◊)

#6(5.4%◊)

#3(1.05%◊)

#0(0%)

#13(15.6%◊)

#0(0%)

Treatment identical, except for intervention *

+ + + + + + +

external validity

Representative population group - + + + + + +

Eligibility criteria defined * + + + + + + +

Statistical validity

Sample size calculation and power + ? + + - - +

Point estimates presented for the primary outcome

+ + + + + + +

Measures of variability presented for the primary outcome

+ + + + + + +

Intergroup statistical significance mentioned

+ + + + + + +

Intragroup statistical significance mentioned

+ + + + + + -

Include an intention- to-treat analysis ? ? ? ? ? ? ?

ADA toothbrush guideline Validity (ADA 2016)

Sample size >N=30 + + - - - + -

Study duration > 30 days - + + + + + -

Safety assessments + + + + + + +

Plaque assessments + + + + + + +

Gingivitis assessments - + + + + - -

Clinical procedure and overnight plaque formation

+ + + + - + +

Funding + + + + + + ?

Authors estimated risk of bias low low low low low low low

Each aspect of the score list was given a rating of ‘+’ for an informative description of the item at hand and a study design meeting the quality standard, ‘-’ for an informative description without a study design that met the quality standard and ‘?’ for missing or insufficient information. When random allocation, defined eligibility criteria, blinding of examiners and patients, balanced experimental groups, identical treatment between groups (except for intervention) and report of follow-up were present, the study was classified as having a low risk of bias. When one of these seven criteria was missing, the study was considered to have a moderate potential risk of bias. When two or more of these criteria were missing, the study was considered to have a high potential risk of bias, as proposed by Van der Weijden et al. (2009).+, Yes; -, No; ?, unknown / not reported; ◊, calculated by the authors of this review based on the presented data in the selected paper; *, reporting criteria for estimation the potential risk of bias; NA, not applicable

Tapered filaments

65

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Yes

TFTB

+ w

ater

ERTB

+ w

ater

3.11

(0.5

7)3.

09 (0

.56)

1.52

(0.5

3) ♦

1.25

(0.4

4) ♦

-1.5

9 (0

.45)

-1.8

4 (0

.54)

Yes

Yes

II Sgan

-Coh

en e

t al.

2005

15Pa

tient

Hyg

iene

Per

form

ance

(PH

P) In

dex

of

Pods

hadl

ey a

nd H

aley

TFTB

+ D

FER

TB +

DF

TFTB

+ D

FER

TB +

DF

Pre

brus

hing

Ba

selin

e:0.

75 (0

.22)

0.81

(0.1

5)60

day

s:0.

75 (0

.26)

0.85

(0.2

0)

Post

bru

shin

gBa

selin

e:0.

56 (0

.25)

0.63

(0.1

7)60

day

s:0.

44 (0

.23)

0.47

(0.2

7)

-0.1

9 ◊

-0.1

8 ◊

-0.3

1 ◊

-0.3

8 ◊

No

No

Yes

Yes

VI Sgan

-Coh

en e

t al.

2008

18Re

fined

Nav

y Pl

aque

Inde

x, m

odifi

ed b

y Ru

stog

i (19

92)

TFTB

-ES

+ D

FER

TB +

DF

4.52

(1.2

6)4.

56 (1

.19)

2.83

(1.4

6)3.

79 (1

.45)

? ?? ?

V Chec

chi e

t al.

2007

20O

’Lea

ry T

J, Th

e pl

aque

con

trol

reco

rd (1

972)

TFTB

+ D

FER

TB +

DF

68.5

3 (1

9.44

◊)72

.47

(16.

92◊)

37.4

0 (1

1.70

◊)51

.33

(15.

68◊)

-31.

13 ◊

-21.

14 ◊

Yes

Yes

Chapter 3

66

b. b

leeD

ING

Inde

x Sc

ores

(bS)

#bl

eedi

ng In

dex

Scor

esG

roup

s

Mea

n (S

D)

Sign

ifica

nt w

ithi

n gr

oups

base

line

end

Diff

eren

ce

II Sgan

-Coh

en e

t al.

2005

15In

terd

enta

l Ble

edin

g In

dex

(198

5)TF

TB +

DF

ERTB

+ D

F0.

29 (0

.33)

0.24

(0.3

1)0.

11 (0

.15)

0.17

(0.2

2)-0

.18

◊-0

.07

◊Ye

sN

o

IV Vers

teeg

et a

l. 20

0817

Blee

ding

on

mar

gina

l pro

bing

(199

4, 2

007)

TFTB

+ D

FER

TB +

DF

1.45

(0.3

0)1.

43 (0

.30)

1.35

(0.3

4)1.

21 (0

.38)

-0.1

0 (0

.43)

♦-0

.22

(0.2

3) ♦

Yes

Yes

C. G

ING

IVA

l In

dex

(GI)

#G

ingi

val I

ndex

Gro

ups

Mea

n (S

D)

Sign

ifica

nt w

ithi

n gr

oups

base

line

end

Diff

eren

ce

II Sgan

-Coh

en e

t al.

2005

15G

ingi

val I

ndex

(Löe

, 196

3)TF

TB +

DF

ERTB

+ D

F0.

22 (0

.26)

0.21

(0.2

8)0.

13 (0

.16)

0.16

(0.2

3)-0

.09

(0.1

4)♦

-0.0

5 (0

.14)

♦Ye

sYe

s

III Ren

et a

l. 20

0716

Gin

giva

l Ind

ex (L

öe, 1

963)

TFTB

-ES

+ D

FER

TB +

DF

1.24

(0.2

3)1.

26 (0

.26)

1.11

(0.1

2)1.

21 (0

.21)

-0.1

3 (0

.14)

♦-0

.05

(0.1

4)♦

No

No

V Chec

chi e

t al.

2007

20G

ingi

val I

ndex

(Löe

, 196

3)TF

TB +

DF

ERTB

+ D

F0.

56 (0

.12◊

)0.

67 (0

.12◊

)0.

18 (0

.08◊

)0.

36 (0

.12◊

)-0

.38♦

(0.1

2◊)

-0.3

1♦ (0

.12◊

)Ye

sYe

s

D.

GIN

GIV

Al

Abr

asio

n (G

A)

#In

dex

Gin

giva

l Abr

asio

n

Inte

rven

tion

gro

ups

Mea

n(SD

)

Sign

ifica

nt W

ithi

n gr

oups

Prod

uct

base

line

end

Diff

eren

ce

IV Vers

teeg

et a

l. 20

0817

Vers

teeg

(200

5)TF

TB +

DF

ERTB

+ D

F0.

94(1

.52)

1.28

(1.8

7)1.

03 (1

.79)

1.44

(1.8

5)+0

.09

(2.1

2) ♦

+0.1

6 (2

.76)

♦? ?

VII

Capo

ross

i et a

l. 20

1619

Vers

teeg

(200

5)TF

TB +

DF

ERTB

+ D

F7.

35 (2

.70)

7.06

(2.6

4)17

.15

◊19

.66

◊+9

.8 (1

3.1)

+12.

6(11

.3)

? ?

TFTB

+ w

ater

ERTB

+ w

ater

7.02

(2.8

2)6.

95 (2

.62)

13.7

2 ◊

17.1

5 ◊

+6.7

(8.2

)+1

0.2

(9.7

)? ?

ERTB

, end

roun

ded

toot

hbru

sh; T

FTB,

tape

red

filam

ent t

ooth

brus

h; T

FTB-

ES, t

aper

ed fi

lam

ent t

ooth

brus

h ex

tra

soft

; DF,

dent

ifric

e; ◊

, cal

cula

ted

by th

e au

thor

s of

this

re

view

bas

ed o

n th

e pr

esen

ted

data

in th

e se

lect

ed p

aper

; ♦, o

btai

ned

by th

e or

igin

al a

utho

rs

Tapered filaments

67

3

APPeNDIx S3 (a & b). Forrest Plots of the performed meta-analysis.

A. PlAQue Index ScoresBaseline

End

Difference

Chapter 3

68

b. GINGIVAl Index ScoreBaseline

End

Difference

Tapered filaments

69

3

APPeNDIx S4. list of abbreviations.

list of abbreviations Abbreviation Meaning

TFTb Tapered filament toothbrush

eRTb End rounded filament toothbrush

FH Fenne Hoogteijling, first author of this paper

DeS Dagmar Else Slot, co-author of this paper

DiffM Difference of means

GAW Godefridus August van der Weijden, co-author of this paper

SD Standard deviation

Se Standard error

SR Systematic review

MA Meta-analysis

RCT Randomized controlled clinical trial

PI Plaque index scores

Tb Toothbrush

Q&H Quigley and Hein plaque index

WM Weighted mean (percentage)

DF Dentifrice

APPeNDIx S5. References used in the appendices.

– American Dental Association (ADA). Council on Scientific Affairs, Acceptance Program Require-

ments; Toothbrushes. 2016 Available from: http://www.ada.org/~/media/ADA/Science%20and%20

Research/Files/guide_toothbrushes.pdf?la=en (accessed 27 October 2016).

– O’Leary TJ, Drake RB, Naylor JE. The plaque control record. Journal of Periodontology: 1972; 43, 38.

– Podshadley AG, Haley JV. A method for evaluating oral hygiene performance. Public Health Rep 1968;

83: 259-264.

– Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR: Refinement of the modified Navy Plaque

Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent 3

1992; (Suppl. C): C9-C12.

– Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analotue of

Vitamine C. J Clin Periodontol 1970; 41: 41-43.

– Versteeg PA, Timmerman MF, Rosema NAM, Warren PR, Van der Velden U, Van der Weijden GA. Sonic-

powered toothbrushes and reversal of experimental gingivitis. J Clin Periodontol 2005; 32: 1236-1241.

– Van der Weijden GA, Timmerman MF, Reijerse E, Nijboer A, Van der Velden U. Comparison of different

approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994; 21:

589-594.


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