Manuscript Type: Original Article

Title: A COMPARATIVE IN VIVO ASSESSMENT OF

BRACKET BOND FAILURE RATE OF TWO SELF -
ETCHING PRIMERS

Authors:

Sam Thomas a, N. R. Krishnaswamyb, Biju Tomc

a
Senior Lecturer, Department of Orthodontics, Sri Ramakrishna Dental College
and Hospital, Coimbatore, India.
b
Professor and Head, Department of Orthodontics, Ragas Dental College and
Hospital, Chennai, India.
c
Senior Lecturer, Department of Orthodontics, Ragas Dental College and
Hospital, Chennai, India.

Corresponding Author:

Dr. Sam Thomas,

Senior Lecturer, Department of Orthodontics, Sri Ramakrishna Dental College,
S.N.R College Road, Avarampalayam, Coimbatore-641006, India,
Email Id: dr.samthomas@gmail.com , Phone no: +91422 4516028,
+91919840269579
 A COMPARATIVE IN VIVO ASSESSMENT OF BRACKET BOND
FAILURE RATE OF TWO SELF-ETCHING PRIMERS

ABSTRACT
Objective: To comparatively assess the clinical bracket bond failure rate of two Self Etching
Primers.

Materials and Methods: Twenty patients seeking orthodontic treatment were divided
randomly into two groups and a split-mouth bonding technique was employed using two Self
Etching Primers; Transbond Plus SEP (3M Unitek, Monrovia, Calif) and Reliance SEP
(Reliance Orthodontic Products, Itasca, IL). The SEPs were used in alternating quadrants so
that they were distributed equally on the left and right sides. Recording of failed brackets
involved only first time failures, and the study was conducted till the leveling and aligning
stage of treatment was completed. Chi – square test was used to determine significant
differences in the bracket bond failure rate, between the two groups, with a 5% level of
significance, using the SPSS v. 11.5.

Results: A total of 5 bracket bond failures were recorded with the Transbond Plus SEP
(Failure Percentage = 3.12%), while only 2 bracket bond failures were recorded with the
Reliance SEP (Failure Percentage = 1.25%).

Conclusions: Fewer clinical bracket bond failures were reported with the Reliance SEP
compared to the conventionally used Transbond Plus SEP, and may provide a suitable
alternative to previously available Self Etching Primers.
INTRODUCTION

Since the advent of the acid etch technique by Buonocore3 and the
bonding of orthodontic brackets by Newman6 in 1965, bonding research has
strived to improve the delivery of orthodontic treatment. Orthodontic bonding
gave rise to significant improvements in treatment such as greater patient
comfort, elimination of the need for pretreatment tooth separation, improved
oral hygiene and esthetics, and reduced chair time. Two areas of clinical
improvement related to direct bonding are reducing the number of steps for
bonding procedures and minimizing the incidence of enamel/bracket bond
failures during treatment.
The conventional three – step procedure (etchant-primer-adhesive); has
stood the test of time and has been used for years to successfully bond
attachments onto the tooth surface. Recent advances in dental bonding
chemistry allow the combination of the etchant and primer into one product
called a Self – Etch primer (SEP) composed of methacrylated phosphoric acid
esters. In the 1990s, self-etch primer was introduced to orthodontics as a way to
save chair time during bonding. Questions about resultant bond strengths have
since been raised, and studied both in vitro and in vivo.

If the bond failure rates of SEPs are comparable with conventional 2-step
etching and priming, then the reduced chair time should make the self-etching
primers more cost-effective. Several studies reported similar bond failure rates
between SEP’s and conventionally bonded brackets. Self Etching Primers were
recently reported to save 10.2 seconds per tooth, for a total of 204 seconds (3.4
minutes) when bonding 20 teeth. The benefits of fewer bonding steps and less
chair time should be weighed against the increased cost of SEPs.

In vitro studies have shown that bond strength produced by Self Etching
Primer is generally clinically acceptable but somewhat lower when compared to
the 3-step procedure. Adequate clinical bond strengths for orthodontic bonding
ranges from 5.9 to 7.9 MPa10.

A commonly studied sixth generation SEP is Transbond Plus (3M Unitek,

Monrovia, Calif),and has been shown to provide clinically acceptable bond
strengths when used with Transbond XT adhesive. This system uses 2 liquids
contained in two separate blister wells that must be mixed in a third well before
use. Transbond Plus SEP contains methacrylated phosphoric acid esters with no
volatile organic solvent and a pH of 1.0.
A SEP introduced recently is the Reliance SEP (Reliance Orthodontic
Products, Itasca, IL) which is a one step self etching primer, intended to be used
for the preparation of a tooth surface prior to bonding an orthodontic
appliance(s) with a light cure adhesive. The Reliance SEP is contained in a
cartridge, which has to be inserted into a hand held dispenser. Upon manual
compression into a light impervious mixing well, enough solution is dispensed
to prepare the enamel surface of up to 20 teeth.
A recent in-vitro study has concluded that the Reliance SEP and the
Transbond Plus SEP have similar bond strengths that are acceptable and that
both are practical options for orthodontic bonding.4 As a clinical situation would
provide a clearer picture with regard to true bond strengths, the purpose of this
study was to evaluate the clinical efficacy of the Reliance SEP in comparison
with the Transbond Plus SEP.

MATERIALS AND METHODS

Twenty patients seeking orthodontic treatment were randomly divided

into two groups: Group A and Group B. The randomization was done using a
software available on the internet (Quick Calcs, Graph Pad Software,
www.graphpad.com/quickcalcs). This software is seeded with the time of day,
so it generates a different result each time it is used. Each patient is first
assigned to a group non-randomly. Then the assignment of each subject is
swapped with the group assignment of a randomly chosen subject.

Brackets and Adhesive

The brackets selected for the study were direct bond stainless steel pre-
adjusted edgewise, Roth 0.022 slot brackets with metallic foil-mesh backing
TM
(Mini-Ovation; Dentsply, GAC) and the adhesive used was Transbond XT
(3M Unitek, Monrovia, Calif). After removal of the excess adhesive, the
TM
brackets were cured using 3M Ortholux XT curing light, with a visible light
range of 400 to 500 nm, for 25 seconds each.

All teeth were pumiced and rinsed, and extra care was taken to remove
any calculus. A split – mouth design was used. For each patient the SEPs were
used in alternating quadrants so that they were distributed equally on the left
and right sides. The SEPs were applied according to the manufacturers'
instructions.

Groups Tested

Group A consisted of ten patients bonded with Transbond Plus SEP (3M
Unitek, Monrovia, Calif) on the maxillary right and the mandibular left
quadrants; and the Reliance SEP (Reliance Orthodontic Products, Itasca, Ill) on
the maxillary left and mandibular right quadrants.

Group B consisted of the remaining ten patients bonded with the

Reliance SEP on the maxillary right and mandibular left quadrants and the
Transbond Plus SEP on the maxillary left and mandibular right quadrants.
 This totaled to 320 teeth being bonded; out of which 160 teeth were
bonded with the Transbond Plus SEP and the other 160 teeth with the Reliance
SEP.

The Transbond Plus SEP combines etchant and primer in a three-well,

single-patient use foil pack with an advanced delivery system. The first
compartment (black reservoir) contains methacrylated phosphoric acid esters,
initiators, and stabilizers. The middle compartment (white reservoir) contains
water, fluoride complex, and stabilizers. The third compartment (purple
reservoir) contains the removable applicator tip.

For activation, the thumb and index finger are used to squeeze the black
reservoir and empty the contents of the first compartment into the middle
compartment (white reservoir). To keep the liquid from flowing back into the
black reservoir, the package is carefully kept folded at the interface of the black
and white reservoir. Using controlled pressure, the liquid is squeezed into the
third compartment (purple reservoir). The applicator tip is then churned and
swirled inside the purple reservoir for 5 seconds, to completely mix the
chemicals and thoroughly coat the applicator tip. The applicator tip is then
removed. It must be moist and have a light yellow color.

The saturated tip of the applicator is then rubbed on the tooth surface, in
small circular motions, for 3 to 5 seconds per tooth. The phosphate group of the
methacrylated phosphoric acid ester dissolves the calcium from the enamel and
removes it from the hydroxylapatite. Rather than being rinsed away, the calcium
forms a complex with the phosphate group and is incorporated into the network
when the primer polymerizes. Because the sixth-generation primers remain in
their unit-dose packages, there is less evaporation and thus a more stable
viscosity and wetting capability. The applicator tip is dipped again into the
reservoir to saturate it, before rubbing it onto the next tooth. When all the teeth
in the particular quadrant are primed, an oil and moisture-free air source is used
to deliver a gentle burst of air onto each tooth, to dry the primer into a thin film.
The gentle burst of air is directed away from the gingiva, so as to avoid any
gingival irritation that may occur with the primer fluid seeping into the gingival
sulcus.
Bonding of the brackets using TransbondTM XT adhesive followed the
priming procedure. After proper bracket positioning, and removal of excessive
adhesive using a scaler, the brackets were light cured using the Ortholux TM XT
curing light.

Patient Inclusion Criteria

All patients had to have a complete permanent dentition with no crowns,

bridges, veneers or restorations anterior to the first permanent molars. The
patients had to be indicated for treatment by fixed orthodontic appliances with
similar projected mechanotherapies, in both the upper and lower arches. The
extraction patterns had to be symmetrical to balance the number of teeth in each
bonding regimen.

The initial archwire placed was 0.014” Nickel-Titanium wire, followed by

various combinations of round and rectangular
Nickel-Titanium and Stainless Steel wires as treatment progressed. Recording
of failed brackets involved only first time failures, and the study was conducted
till the leveling and aligning stage of treatment was completed. Informed
consent was obtained from all patients.

RESULTS

Chi – square test was used to determine significant differences in the

bracket bond failure rate, between the two groups, with a 5% level of
significance, using the SPSS v. 11.5.
 A total of 5 bracket bond failures were recorded with the Transbond Plus
SEP(3M Unitek, Monrovia, Calif), whereas only 2 bracket bond failures were
recorded with the Reliance SEP (Reliance Orthodontic Products, Itasca, Il). The
number of bracket bond failure rates and their statistical significance is
presented in Table 1, and a bar graph that illustrates the same is shown in Figure
1.

Chi-square tests were also done to assess the bond failure rate between
the anterior and posterior segments of the arch, and no statistically significant
differences were recorded. (Figure 2)

DISCUSSION

The advent of bonding has revolutionized orthodontic treatment

immensely. Efficient orthodontic treatment with fixed appliances requires
adequate bond strength of brackets to the enamel surfaces of the teeth.

Since the depth of enamel dissolution during the etching process is

important, the potential use of alternative enamel conditioners has been studied
to improve the bonding procedure by minimizing enamel loss and reducing
chair time while still maintaining sufficient bond strengths between brackets
and enamel.

Recent advances in dental bonding chemistry allow the combination of

the etchant and primer into one product called a Self Etching Primer composed
of methacrylated phosphoric acid esters. In the 1990’s SEP was introduced as a
means of reducing chair time during bonding. Adequate clinical bond strengths
in orthodontics range from 5.9 to 7.9 MPa as reported by Reynolds and Von
Fraunhofer10. Aljubouri et al1 found that mean SBS of brackets bonded with
Self etching primer was lower than those bonded with a conventional etch.
 Prompt L-Pop, a Self-Etching Primer, was the first sixth-generation
adhesive to be released to the dental market12. The same chemistry is employed
in the Transbond Plus Self-Etching Primer, an identical product marketed
specifically for orthodontics, introduced by 3M Unitek (Monrovia, Calif) in late
2000. Although fifth-generation adhesives allowed clinicians to bond in a moist
environment, they still required etching with phosphoric acid to achieve the
bond strength necessary for orthodontic applications. Bond failures can occur if
the etchant is left on too long, which yields weak enamel rods, or if it is not
rinsed properly, which reduces the bond strength. The sixth-generation primers
provide comparable bond strengths without the time-consuming process of
applying and rinsing the etchant.12

The purpose of this study was to compare the bracket bond failure rate
with two commercially available Self Etching Primers during the leveling and
aligning stage of treatment.
Bond failure rates obtained by in-vitro studies might not mirror the real
world of clinical practice. Most studies are conducted in vitro and use shear/peel
or tensile forces to evaluate bond strength. Sunna and Rock11 found that in-vitro
bond strengths had no correlation with clinical bond failure rates.
One explanation might be that brackets bonded to teeth undergoing
orthodontic treatment are subjected to many different forces (eg, torque, shear,
tensile) and might be subjected to more than one type simultaneously.
Conversely, in-vitro studies test only pure shear or pure tensile forces
independently; this might not accurately represent the intraoral environment.
Ultimately, the in-vivo bond failure rate will determine the usefulness of
a particular bonding system, and caution should be used when inferences are
made from in-vitro bonding studies. To date, published reports on the in-vivo
efficacy of SEPs for orthodontic bonding are limited.9
 Keeping this aspect in mind, it was the aim of this in – vivo study to
compare the bracket bond failure rate and thereby the clinical efficiency of the
Transbond Plus SEP and the Reliance SEP.
The brackets used in this study were Mini-Ovation (Dentsply, GAC)
stainless steel brackets. These brackets had a 0.22 slot and a metallic foil-mesh
backing.
The light curing kit used in this study is the Ortholux™ XT Curing Light
(3M Unitek, Monrovia, CA). This is a conventional light curing unit, which
uses a halogen lamp to generate a white light which is then filtered so that only
blue light in the 400 to 500 nanometer range is emitted from the tip. Each
bracket bonded in this study was cured for a total time of 25 seconds each,
curing the labial, occlusal, gingival, mesial and distal aspect of the bracket for 5
seconds each.

The twenty patients, who participated in this study, were randomly

allocated to two groups, Group A and Group B, using the GraphPad Software,
available online. (www.graphpad.com/quickcalcs). This random number generator is
seeded with the time of the day, so it works differently each time it is used.
Each patient is first assigned to a group non randomly. Then the assignment of
each subject is swapped with the group assignment of a randomly chosen
subject.

Asgari et al2 compared Transbond Plus Self etching primer with a

traditional acid etch sequence in vivo and found that those brackets bonded with
Self etching primer had a significantly lower incidence of debond. They
incorporated a pumice prophylaxis for all groups. Similarly, a recent in vivo
study by Ireland et al5 tested Transbond Plus Self etching primer versus
conventional etch but disregarded the pumice prophylaxis step for all groups.
They found a significantly greater number of bond failures occurring within the
Self etching primer group.
 Self etching primers with a lower pH are typically more aggressive than
those that are not as acidic; they have consistently shown greater enamel-dentin
dissolution, a deeper etching pattern, and the formation of thicker hybrid
layers7. It was concluded that the pH of the self etching primer was not the only
determining factor in the self-etchant's aggressiveness. The authors suggested
that other factors, including the acid dissociation constant, compound structure,
application time, and the solubility of the salts formed by the interactions, also
influence the action of self etching primer.
Historically, it was assumed that the primary mechanism of retention
during bonding was the mechanical interlocking between the enamel and the
adhesive. As a result, it was thought that a deeper etching pattern would provide
a greater surface area for bonding and, thus, greater bonding strengths7.

Pashley and Tay8 reported that the efficacy of Self etching primer did not
depend on their etching aggressiveness.

Anthony Pasquale9 comparatively assessed the bond failure rates of

orthodontic brackets bonded with 2 self-etching primer (SEP) bonding systems;
Transbond Plus SEP (3M Unitek) and Ideal 1 SEP (GAC International) over an
18-month period. They concluded that the Ideal 1 SEP bonding system had 3
times as many bracket failures as the Transbond Plus SEP bonding system; and
that clinicians should consider the many associated costs of bracket failures
(chair time, material costs) when choosing bonding systems.
Since the product is new to the orthodontic market, literature on the
Reliance SEP is minimal. A recent study by L. Evans, K.R. McGrory, J.
English4 compared the shear bond strengths of three SEP's – Transbond Plus
SEP, Reliance SEP and Ideal-1 Self Etching Primer; to a conventional bonding
system, and also looked at how each responded when contaminated with either
saliva or water. The in-vitro study used 240 bovine incisor teeth and divided
them into 4 groups of 60 each. They concluded that both Transbond Plus Self-
etching Primer and Reliance Self-etching Primer had bond strengths similar to
those of the control group treated with phosphoric acid.

The results of this study showed a clinically significant, fewer bracket

bond failure rates with the Reliance Self Etching Primer when compared with
the Transbond Plus Self Etching Primer. Out of the total 320 brackets bonded, 7
brackets showed bond failure. The Transbond Plus SEP had 5 bracket bond
failures, while the Reliance SEP had 2 bracket bond failures. There was no
statistically significant difference between bracket bond failures in the anterior
or posterior segments of the arch, in this study.

CONCLUSION

The results of the statistical tests showed that the Reliance S.E.P. had
fewer bracket bond failures clinically when compared to the Transbond Plus
S.E.P.

Based on the statistical results derived from this study, the following
conclusions were drawn:

1. The Reliance S.E.P. is a suitable alternative to the commonly used

Transbond Plus S.E.P. as it showed clinically fewer bracket bond failures
in this study.
2. Since the Reliance SEP is contained in cartridges and the unused solution
can be stored for upto six hours in light impervious mixing wells, there is
minimal wastage of the material.
3. There was no statistically significant differences found between bracket
bond failures between the anterior and posterior segments of the arch.

The Self- etching primer that has been introduced to overcome the
laborious process of etching and priming will definitely reduce the chair side
time and the ill effects of acid etching. By reducing the number of steps during
bonding, the clinicians are able to save time as well as reduce the potential for
error and contamination during the bonding procedure.

Since the Reliance SEP is a newly introduced Self Etching Primer, and
due to the lack of literature-based efficiency, further in-vivo studies should be
conducted to evaluate the same.
REFERENCES

1. Aljubori YD, Millet DT, Gilmora WH. Laboratory evaluation of a

self etching primer for orthodontic bonding European J of Ortho.

2003; 25: 411-5.

2. Asgari S, Salas A, English J, Powers J. Clinical evaluation of bond

failure rates with a new self etching Primer. JCO 2002; 36: 687-689.

3. Bunocore MG. A simple order of increasing adhesion of acrylic filling

material to enamel surface, J Dent.Res.1955; 34:849-853.

4. Evans, K.R. Mcgrory, J. English A Comparison of Shear Bond

Strengths Among Different Self-Etching Primers; Texas Dental

Journal; April 2009, 126(4):312-9.

5. Ireland, Helen Knight, and Martyn Sherriff, An in vivo investigation

into bond failure rates with a new self-etching primer system, Am J

Orthod Dentofacial Orthop Volume 124, Number 3, 2003.

6. Newman. G.V., Acrylic Adhesive for bonding attachments and tooth

surface. Angle Orthodontist 1968: 38:8-12.

7. Ostby, Bishara, Denehy, Laffon, Warren. Effect of self etching PH on

shear bond strength of orthodontics brackets. Am.J of orthodontics

2008: 134;203-208.

8. Pashley D. H, Tay FR , Aggressiveness of contemporary self-etching

adhesives. Part II: etching effects on unground enamel. Dent Mater.

2001 Sep;17(5):430-44.
 9. Pasquale, Martin Weinstein, Alan J. Borislow, and Leonard E.

Braitman, In-vivo prospective comparison of bond failure rates of 2

self-etching primer/adhesive systems, Am J Orthod Dentofacial Orthop

2007;132:671-4.

10. Reynolds FR, Von Fraunhofa JA, Direct bonding of orthodontic

attachment to teeth: the relation of adhesive bond strength to mesh

size: British J of orthodontist 1976.

11. Sunna S, Rock WP, Clinical performance of orthodontic brackets and

adhesive systems: a randomised clinical trial. Br J Orthod

1998;25:283-7.
12. White CW, An expedited bonding technique, JCO 2001, 35:36

FIGURE LEGENDS

Figure 1 : Bar Diagram showing bracket bond failures in Group A and Group B.
Figure 2 : Bar Diagram showing bracket bond failures in the anterior and

posterior segments of the arch.