RANDOMIZED CONTROLLED TRIAL

Comparison of pain perception during

miniscrew placement in orthodontic patients
with a visual analog scale survey between
compound topical and needle-injected
anesthetics: A crossover, prospective,
randomized clinical trial
Jordan A. Lamberton,a Larry J. Oesterle,b W. Craig Shellhart,c Sheldon M. Newman,d Ricky E. Harrell,e
Terri Tilliss,e Neha Singh,f and Clifton M. Careyg
San Francisco and Napa, Calif, and Aurora, Colo

Introduction: The use of a compound topical anesthetic (CTA) instead of an injection of a local anesthetic for
placing miniscrew implants offers advantages to both the clinician and the patient. The purpose of this crossover,
prospective, randomized clinical trial was to compare the clinical effectiveness of a CTA with that of a needle
injection of local anesthetic for miniscrew placement. Methods: Twenty-four orthodontic patients in a university
clinic were recruited; they required bilateral buccal miniscrews for orthodontic anchorage. Eligibility criteria
included healthy patients with no special needs; over 8 years of age and 25 pounds; not taking sulfonamides,
monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines; and not allergic to ester-type local
anesthetics or any of the other materials used in the study. A computer generated a randomization list. The
allocation was randomized by anesthetic protocol and side of the mouth, and was restricted to achieve
balance by treatment and side of the mouth. No allocation concealment was applied. Associated with each
randomized number was the subjects' assignment into 1 of 4 groups divided by the side of first miniscrew
placement and the type of anesthetic. Blinding was done only for data analysis because of clinical limitations.
Each patient received a CTA on one side and an injection of anesthetic on the other before miniscrew
placement in a crossover study design. The outcome was assessed by measuring pain levels with a 100-mm
visual analog scale at 5 time points. Anesthetic failures occurred when the miniscrew could not be fully
comfortably placed with a given anesthetic. Data were organized by visual analog scale time points, and
descriptive statistics were calculated. A factorial repeated-measures analysis of variance was used to
determine any differences. Results: Twenty-seven patients were assessed for eligibility, and 24 agreed to
participate in the study. Patients did not distinguish any differences in pain between the application of the
CTA and the injection before or during anesthetic placement, but they experienced more pain with the CTA
during miniscrew placement. The mean difference for the entire procedure between the 2 anesthesia types
was 24.6 units, and the 95% confidence interval was 18.8 to 30.4, a statistically significant finding
(P 5 0.0002). The CTA was still viewed as more painful 1 month after the procedures. Significantly more anes-
thetic failures occurred with the CTA (41.6%) than with the injection (0%). No serious harm was observed in any
patient; when significant pain was observed with the CTA, a needle injection of local anesthetic was adminis-
tered. Conclusions: CTAs provided less predictable, often inadequate, and less comfortable anesthesia

a g
Associate professor, University of the Pacific, San Francisco, Calif; private prac- Professor, Department of Craniofacial Biology, University of Colorado, Aurora,
tice, Napa, Calif. Colo.
b
Professor and director of research, Department of Orthodontics, University of All authors have completed and submitted the ICMJE Form for Disclosure of Po-
Colorado, Aurora, Colo. tential Conflicts of Interest, and none were reported.
c
Professor and interim chair, program director, Department of Orthodontics, Uni- Address correspondence to: Larry J. Oesterle, Department of Orthodontics, Uni-
versity of Colorado, Aurora, Colo. versity of Colorado, Mail Stop F849, 13065 E 17th Ave, Aurora, CO 80045;
d
Associate professor, Departments of Restorative Dentistry and Orthodontics, e-mail, larry.oesterle@ucdenver.edu.
University of Colorado, Aurora, Colo. Submitted, September 2011; revised and accepted, August 2015.
e
Professor, Department of Orthodontics, University of Colorado, Aurora, Colo. 0889-5406/$36.00
f
Statistician consultant, Aurora, Colo. Copyright Ó 2016 by the American Association of Orthodontists.
http://dx.doi.org/10.1016/j.ajodo.2015.08.013

15
16 Lamberton et al

than an injection of a local anesthetic for managing patient discomfort during miniscrew placement in buccal
sites. Registration: This trial was not registered. Protocol: The protocol was determined and approved by
the research committee and institutional review board before the trial. Funding: No external funding was
used other than the donation of the miniscrews from Rocky Mountain Orthodontics, and no conflict of interest
was declared. (Am J Orthod Dentofacial Orthop 2016;149:15-23)

M
iniscrew implants, a type of orthodontic tem-
porary anchorage device, are a simple yet
effective means of increasing the efficiency
and predictability of orthodontic treatment.1-6 Mah
and Bergstrand7 advocated that orthodontists should
place miniscrew implants (miniscrews) because of their
better understanding of the biomechanical requirements
and of the optimal placement of the miniscrews. Howev-
er, a recent survey reported that only 55% of orthodon-
tists were placing miniscrews themselves, and the
reported reasons for referring it out were the invasive-
ness of the procedure and the associated pain and anx-
iety for the patient.8 Topical anesthesia, rather than
needle injections of anesthetic, is a less invasive method
of pain control that may decrease patient anxiety and
simplify the anesthetic procedure for the orthodontist.
Although many clinical studies describe placing mini-
screws using needle injections of local anesthetic,1-6,9
some authors have suggested that a compound topical
anesthetic (CTA) could be used as the sole anesthetic
for placing miniscrews.10-12 Shirck et al13 surveyed 61
orthodontists in private practice in the United States
about their miniscrew use and found that 30.8% use
only CTAs when placing miniscrews. There are several
advantages of using a CTA for placing miniscrews,
including patient comfort; simplicity of the procedure
for the orthodontist; lack of tissue ballooning, which
can obscure the miniscrew implant placement site; and
patient feedback if the miniscrew is placed too close to
the root structure.11,12
SPECIFIC OBJECTIVES AND HYPOTHESES
Since there are primarily only expert opinion reports
in the literature, it is unclear whether a compound
multidrug topical anesthetic is as clinically effective
as a traditional needle injection of local anesthetic
for pain control during miniscrew placement. The pur-
pose of this study was to compare the clinical effective-
ness of a compound multidrug topical anesthetic
application with a traditional needle injection of local
anesthetic in managing patient discomfort during
miniscrew placement. The hypothesis was that a topical
anesthetic provides the same level of pain control for
miniscrew placement as does needle-injected local
anesthetic.
MATERIAL AND METHODS
Trial design
This was a cross-over, prospective, cross-arch
randomized, controlled clinical trial with a 1:1 allocation
ratio for anesthetic use.
Participants, eligibility criteria, and settings
A total of 27 patients undergoing orthodontic treat-
ment at the Department of Orthodontics clinic, School of
Dental Medicine, at the University of Colorado were re-
cruited as study participants. Only 24 of them agreed to
participate in the study. Approval from the Colorado
Multiple Institutional Board was obtained before patient
recruitment (protocol number 10-0897). Consecutive
orthodontic clinic patients meeting the following inclu-
sion criteria were enrolled: (1) healthy, with no signifi-
cant medical findings or special needs; and (2)
requiring at least 2 miniscrew implants that were
buccally located on opposite sides of the dental arch,
placed in similar anteroposterior locations, and in the
same dental arch. Exclusion criteria were patients (1)
who were currently taking or had recently taken sulfon-
amides, monoamine oxidase inhibitors, tricyclic antide-
pressants, or phenothiazines; (2) with allergies to
ester-type local anesthetics or any of the other materials
used in the study; (3) with hypertension; (4) with past or
current cardiac disease; (5) who use tobacco; (6) with
bone metabolic disease; (7) who weighed less than 25
lbs or were less than 8 years old; (8) with same-day
use of analgesics before the procedure; and (9) who
were unable or unwilling to consent to the study.
Interventions
At the time of recruitment, each participant who met
the inclusion and exclusion criteria was given a brief
explanation of the study by 1 author (J.A.L.). Verbal
and written consents to participate in the study were ob-
tained from both the patient and the parent. Because
only patients requiring 2 miniscrew implants were re-
cruited for this study, the 2 types of anesthetics were
compared in the same patient in a crossover, cross-arch
study design. The 2 miniscrew placements, with the
different anesthetics, were separated by at least 7 days
to allow sufficient time for the patient to disassociate

January 2016  Vol 149  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Lamberton et al
the 2 procedures. The placement sequence of the 2 anes-
thetic types and the side of the dental arch first treated
were randomized between consecutive patients.
The CTA used in this study was a compounded
mixture of 10% prilocaine, 10% lidocaine, 4% tetra-
caine, and 2% phenylepherine. The CTA was specifically
compounded by Steven's Pharmacy (Costa Mesa, Calif)
based on the prescription provided by an author
(R.E.H.). This specific mixture of topical anesthetics
and phenylephrine, called PFG by Steven's Pharmacy,
was also recommended by other authors.10 A cotton
tip applicator was used to administer the CTA for each
procedure. In a pilot study, we found that the amount
of CTA administered with 1 cotton tip application had
a mean weight of 0.18 6 0.04 g; this confirmed the
pharmacy's claim that a coated cotton tip application
of the CTA was equal to approximately 0.125 to
0.25 g.14 Before CTA application, the soft tissue site
for miniscrew placement was thoroughly dried with a
2 3 2-in piece of gauze. The CTA was applied on and
around the attached gingiva and the alveolar mucosa
of the miniscrew placement site with a cotton tip appli-
cator and left in place for 2.5 minutes. The area was then
wiped with gauze and rinsed thoroughly, as per the
pharmacy's recommendation.
The needle-injected anesthetic was 2% lidocaine hy-
drochloride with 1:100,000 epinephrine (Henry Schein,
Melville, NY). Before the needle injection, the soft tissue
site for miniscrew placement was dried with a 2 3 2-in
piece of gauze. Then a cotton tip swab with 0.25 g of a
single drug topical anesthetic, consisting of 20% benzo-
caine (Benzo-Jel; Henry Schein), was placed for 2 min-
utes to lessen the patient's discomfort during the
needle penetration. Approximately 0.45 mL of lidocaine,
or a quarter of a carpule, was then injected as a buccal
infiltration into the alveolar mucosa around the
miniscrew placement site. A 0.45-mL dose of lidocaine
provides an acceptable degree of anesthesia, while still
allowing patient feedback in case the miniscrew contacts
the periodontal ligament (PDL). All anesthetic expiration
dates were checked before use to ensure efficacy. The
miniscrews used in this trial were Dual-Top Miniscrews
(Rocky Mountain Orthodontics, Denver, Colo) and were
placed with a hand driver. All miniscrew implants had
a 1.6-mm-diameter width and a 6-mm length for use
in the anterior segments, and an 8-mm length for use
in the posterior segments.
Outcomes (primary and secondary) and any
changes after trial commencement
The outcomes measured in this trial were the pa-
tients' comfort levels during miniscrew placement with
American Journal of Orthodontics and Dentofacial Orthopedics
17
the CTA and the needle-injected anesthetic. A visual
analog scale (VAS) was used for measuring the pain
levels; it is a common and proven method of measuring
pain levels in patients.15 The participants were familiar-
ized with the 100-mm VAS for pain measurement in a
scripted presentation. They were asked to indicate their
degree of discomfort (0 mm, no pain; 100 mm, worst
pain imaginable) on the VAS survey form before
receiving the anesthetic and before the miniscrew was
placed (T0). This pretreatment VAS survey was used to
determine the preoperative pain level and allow compar-
ison of the consistency of the 2 baseline VAS scores from
the same subject at 2 dates. One author (J.A.L) moni-
tored the recording at T0 to ensure each subject's full
comprehension of the treatment protocols. The proce-
dure began immediately after the T0 VAS scoring.
A VAS survey was taken immediately after each time
point of the anesthetic protocols. The patient was asked
to evaluate the pain felt during the anesthesia procedure
only (T1) by completing the VAS survey immediately af-
ter anesthetic administration. The miniscrew was then
placed by the patient's orthodontic resident. Multiple
residents, each well trained and experienced in
miniscrew placement, placed the miniscrews during the
trial; both miniscrews were placed by the same ortho-
dontic resident in the same patient. Immediately after
miniscrew placement, 2 postoperative VAS surveys
were filled out (T2a and T2b). Each subject first evalu-
ated the pain felt during only the miniscrew placement
(T2a); on the second survey, the patient evaluated the
overall pain experience for the entire procedure,
combining the anesthesia and miniscrew procedures
(T2b). The levels of discomfort (0 mm, no pain;
100 mm, worst pain imaginable) for each procedure
were recorded on separate VAS surveys. Before each
miniscrew was placed, the patients were told that if
they felt greater discomfort than what they deemed
moderate discomfort, they could be given more anes-
thetic delivered by injection. If at any time during either
miniscrew procedure the patient felt a need for more
anesthetic, the procedure was stopped and the subject
completed both VAS surveys (T2a and T2b). This was
counted as an anesthetic failure for that anesthetic
group. A needle injection of lidocaine anesthetic was
then given by infiltration until the subject was comfort-
able, and the procedure was completed. If the PDL was
inadvertently contacted with a miniscrew, as evidenced
by the patient's response and the tactile sensation of
the operator, that patient would be excused, and any
data collected from that patient would be eliminated
from the study. The patient could continue treatment
but not as a study patient. No patient in the study expe-
rienced PDL pain during miniscrew placement.
January 2016  Vol 149  Issue 1
18
The second miniscrew placement appointment
occurred a minimum of 7 days after the first to allow
the patients to disassociate any pain they might have
experienced during the first procedure. A baseline VAS
survey (T0) was again scored preoperatively, and each
subject was given the other anesthetic from that used
for the opposite side of the mouth. Immediately after
the second anesthetic procedure, the patient completed
another VAS (T1) survey to evaluate the pain felt during
the anesthesia procedure only. Immediately after the
second miniscrew placement, both follow-up VAS sur-
veys were completed by the patient (T2a and T2b).
One month after the second miniscrew procedure,
the patient evaluated the combined overall pain experi-
enced during the first anesthetic and miniscrew proce-
dure, and then the second anesthetic and miniscrew
procedure on separate VAS surveys (T3). These surveys
represented the patient's recollection of the level of
pain experienced while placing the miniscrews. The pa-
tients were reminded which anesthetic was used at
each appointment. That completed the study, and each
patient was given a $10 gift card.
Both anesthetic procedures were administered by 1
researcher (J.A.L.), experienced in both procedures, to
eliminate confounding variables. No changes in the pro-
tocol were made to the trial after it started.
Sample size calculation
The sample size was estimated using a previous
study's standard deviation of 32 mm and a clinically sig-
nificant difference of 20 mm on a 100-mm VAS at a
power of 0.80 and an alpha of 0.05, resulting in 21
subjects needed per anesthetic type.16 Since each patient
had one of each type of anesthetic, 21 patients were
required for the study. A total of 27 patients were re-
cruited for an expected attrition rate of less than 20%.
Three patients declined to participate in the study.
Interim analyses and stopping guidelines
No interim analysis was performed during the study,
and no guidelines were established for stopping the trial.
However, as part of the protocol, the miniscrew place-
ment procedure on a patient was stopped if he or she
complained of pain.
Randomization (random number generation,
allocation concealment, implementation)
The sequence of anesthetic placement and the side of
the mouth were randomized. A randomization list was
generated by computer. The allocation was randomized
by the anesthetic protocol and the side of the mouth,
and was restricted to achieve balance by treatment and
January 2016  Vol 149  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Lamberton et al
side of the mouth. No allocation concealment was
applied (Fig 1).
Blinding
Blinding of the patient and the clinician was not
possible during the trial because of the nature of the
trial. Blinding occurred only during the data analysis.
The measurement of the VAS surveys was performed
by 1 author (J.A.L.), who, during data analysis, was
blinded to the anesthetic type and the sequence used
for each procedure by the randomized number assigned
to each patient.
Statistical analysis (primary and secondary
outcomes, subgroup analyses)
The data were organized by the VAS survey time
points, and descriptive statistics were calculated (means
and standard deviations) for the topical and injection
modes of anesthesia delivery. We observed a numeric
difference in VAS measurements and, therefore, per-
formed a factorial repeated measures analysis of vari-
ance (ANOVA) for this data set (SPSS version 19; IBM,
Armonk, NY). This test analyzed differences between
the anesthetic types (topical vs injection) and also within
the participants' variables (T0, T1, and T2a) with
repeated measurements. This allowed us to determine
the main effects of the treatment types, time passage,
and also their interactions. The alpha level for all statis-
tical tests was set at P # 0.05. Age and sex vs VAS score
at each time point were graphically evaluated, and the
linear correlation coefficients were calculated to investi-
gate the effects of age or sex on the VAS measurements.
Additionally, factors such as age, sex, T0 (baseline VAS),
and T1 (anesthetic VAS) were evaluated for significance
between the failures and the nonfailures to assess their
usefulness as predictors of success or failure of the
CTA procedure using t tests in each group.
RESULTS
Participant flow
A total of 27 patients were assessed for eligibility for
the study. Of these, 24 met the criteria and agreed to
participate. The treatment was the normal and
customary treatment given to patients, whether or not
they participated in the study. The only deviation from
routine orthodontic care was the type of local anesthesia
used for placement of the planned miniscrews. All 24 pa-
tients who were recruited completed the study. Their
average age was 19.9 years, with a range of 13 to
54 years. Fourteen patients were female, and 10 were
male. Patient recruitment started in February 2011 and
was completed in September 2011. The number of
Lamberton et al 19

Fig 1. CONSORT flow diagram of the distribution of patients in the study.

possible patients was limited by the requirement that scores for each subject were recorded. Placement sites
bilateral miniscrews must have been planned for ortho- were noted as maxillary posterior (distal to canine)
dontic anchorage during treatment. (16), maxillary anterior (mesial to canine) (4), mandibular
posterior (distal to canine) (1), and mandibular anterior
Baseline data (mesial to canine) (3) regions, but site locations were
not used as study inclusion criteria or for analysis
All patients in this trial were active orthodontic pa-
tients; therefore, full orthodontic records were made
before the start of treatment. The records included a Table I. Patient demographic characteristics and
health history, a detailed clinical interview and examina- placement sites
tion, study casts, panoramic and lateral cephalometric
CTA (n 5 24), Injection (n 5 24),
radiographs, anterior periapical and bitewing radio- mean (SD) or mean (SD) or
graphs, a full orthodontic analysis of the records, and counts counts
an outline of treatment objectives and a treatment Age (y) 19.9 (10.1) 19.9 (10.1)
plan. The demographic data were taken from these Sex (n)
Male 10 10
records (Table I).
Female 14 14
Placement sites (n)
Numbers analyzed for each outcome, estimation Maxillary anterior 4 4
and precision, subgroup analyses Maxillary posterior 16 16
Mandibular anterior 3 3
The age; sex; placement sites; types of anesthetic; Mandibular anterior 1 1
anesthetic failures; and T0, T1, T2a, T2b, and T3 VAS VAS T0 (baseline) 7.2 (13.1) 1.8 (4.6)

American Journal of Orthodontics and Dentofacial Orthopedics January 2016  Vol 149  Issue 1
20 Lamberton et al

Fig 2. Plotted individual VAS scores with means and standard deviations for each anesthetic type at
the evaluation times: T0 (baseline pain), T1 (anesthesia only procedure pain), T2a (pain during
miniscrew placement), T2b (pain of the entire procedure), and T3 (pain recollection at 1 month).

because of the low numbers at some sites. The VAS
scores were measured in millimeters from zero on the
left to the patient's vertical mark using a digital caliper,
yielding a VAS score from 0 to 100.
There were no significant differences in mean VAS
scores within or between the CTA or injection applica-
tions between T0 and T1. There was, however, a differ-
ence in mean VAS scores between the T2a and both the
T0 and T1 VAS scores for the CTA application only, with
the T2a VAS scores significantly higher for the CTA
application (P \ 0.001) (Fig 2; Table II). The mean dif-
ference for the entire procedure (T3b) between the 2
anesthesia types was 23.8 VAS units, and the 95% con-
fidence interval (CI) was 17.9 to 29.7, which was a
statistically significant finding (P 5 0.0002). At T1
(postanesthetic placement), the mean difference was
–5.5 units, and the 95% CI was 4.3 to 6.7, which was
not a statistically significant finding (P 5 0.168). How-
ever, after placement of the miniscrew (T2a), there was a
statistically (P \ 0.001) and clinically significant differ-
ence, with a mean difference of 34 VAS units and a 95%
CI of 25.6 to 42.4. This significant difference (P 5 0.002)
between the anesthesia types was maintained 1 month
later (T3), with a mean difference of 23.8 units and a
95% CI of 17.9 to 29.7. The CTA was not as comfortable
for the patients as the injected anesthetic. The CTA
application had 10 anesthetic failures (a 46.1% failure
rate), whereas the injection application had no failures

January 2016  Vol 149  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Lamberton et al
Table II. Results with means, standard deviations, statistical significance values, and 95% confidence intervals
CTA (n 5 24),
mean (SD) (mm)
VAS T1, postanesthesia 5.4 (12.1)
VAS T2a, postminiscrew 41.6 (30.5)
VAS T2b, entire procedure 33.9 (26.6)
VAS T3, recollection at 1 month 36.5 (30.8)
T1, VAS score after the anesthetic but before the miniscrew was placed; T2a, VAS score immediately after the miniscrew was placed; T2b, VAS score
when the patient combined the anesthetic and miniscrew procedures; T3, VAS score 1 month later evaluating both the anesthetic and the miniscrew
procedures.
(0% failure rate), which was a statistically significant dif-
ference (P 5 0.004). No significant associations were
found between age or sex vs VAS measurements at any
time point. No factor (age, sex, T0, or T1) was signifi-
cantly different between the failures and nonfailures
(P . 0.05). The risk of anesthetic failure with the CTA
application was 41.6%, and the risk of failure with the
needle-injection application was 0%. Needle injection
of anesthetic is a known and reliable procedure and
acted as the control. However, the small sample sizes
prevented accurate comparisons of all secondary factors.
The primary factors, comparing the entire procedure and
the anesthetic failures, were significantly more uncom-
fortable for the patients when the CTA was used.
Harms
No significant harms were observed during the trial,
other than the discomfort experienced by some patients
receiving the CTA. When the CTA did not provide
adequate anesthesia for miniscrew placement, local
anesthetic was injected; this provided adequate anes-
thesia in all patients. Although contact with the PDL or
tooth root when placing the miniscrew was always a
risk, it did not occur in any patient during the study,
attesting to the expertise of the residents placing the
miniscrews.
DISCUSSION
Main findings in the context of the existing
evidence, interpretation
In this trial, we compared the use of a CTA and a
needle-injected anesthetic for local anesthesia before
placing the miniscrews for orthodontic anchorage.
Because miniscrews are used routinely during orthodon-
tic treatment, it is important to determine the most effi-
cient and effective anesthetic procedure before their
placement. Although several clinical reports1-6,9 have
described placing miniscrews with needle injections of
local anesthetic, other authors10-12 have reported that
a CTA could be used as the sole anesthetic for placing
American Journal of Orthodontics and Dentofacial Orthopedics
21
Injection (n 5 24), Mean
mean (SD) (mm) difference (mm) 95% CI (mm) P value
10.9 (15.0) 5.5 4.3-6.7 0.168
7.6 (9.5) 34.0 25.6-42.4 \0.001
9.3 (12.1) 24.6 18.8-30.4 \0.001
12.7 (16.0) 23.8 17.9-29.7 0.002
miniscrews. However, these were all clinical reports
and not clinical trials. Unlike other pain studies, we did
not find any significant correlations between the VAS
scores for patients of different ages or sexes at any
time point, but the small sample size by age and sex
prevented any secondary conclusions.17 There are
several advantages of using a CTA for placing
miniscrews, including patient comfort; simplicity of
the procedure for the orthodontist; lack of tissue
ballooning, which can obscure the miniscrew placement
site; and patient feedback of discomfort if the miniscrew
is placed close to a root structure.11,12 Reznick et al,16 in
the only reported similar trial, found that a topical anes-
thetic compounded with lidocaine, tetracaine, and
phenylephrine (TAC 20%) was more effective in control-
ling pain during miniscrew placement than a single-drug
topical composed of 20% benzocaine gel. In their study,
which also used a 100-mm VAS, they found that when
20% benzocaine was used topically as the sole anes-
thetic agent, the patients reported a mean VAS pain
score of 92.7 6 46.1, compared with a mean score of
33.1 6 32.2 when receiving a CTA: a statistically signif-
icant difference and a high pain level for the single-
topical agent. They had a 100% success rate when
placing miniscrews with the CTA. In the study of Reznick
et al, the mean T2a VAS score (33.1 6 32.3) for the CTA
application was 8.5 mm less than the mean VAS score
(41.6 6 30.5) in our study for the CTA application during
placement of the miniscrews. We had a 46.1% failure
rate when placing miniscrews with the CTA and did
not continue with miniscrew placement when the pa-
tient felt significant pain; Reznick et al completed the
procedure in spite of the patients' high pain level
(92.7 6 46.1). Our study found a higher, yet close,
VAS score and a higher failure rate with the CTA applica-
tion owing to (1) differences in the study population; (2)
the patient's awareness of an injection alternative; (3)
use of 1 topical drug instead of an injection of anesthetic
as the contrasting anesthetic; (4) a small difference in
compounding formulas of the CTAs; and (5) different
residents placing the miniscrews in our study rather
January 2016  Vol 149  Issue 1
22
than 1 faculty member performing the actual miniscrew
placements as in Reznick et al's study. Because each
orthodontic resident in our study placed a miniscrew
with each type of anesthetic, the confounding variable
of having multiple operators placing the miniscrews
was decreased. However, evaluating pain is highly com-
plex, and although we attempted to separate the evalu-
ations at each time point, the overall pain scoring after
1 month may have involved some crossover between
the procedures. The primary difference between the
studies was the availability and need for additional in-
jected anesthetic during the procedure when the CTA
alone was used.
Reznick et al16 demonstrated that miniscrews could
be placed using a CTA as the sole anesthetic when
compared with a single-drug topical anesthetic. Howev-
er, we found that when placing a miniscrew a CTA did
not provide as much profound pain control as did an in-
jection of local anesthetic, which is the gold standard for
pain control. Also, whereas in both studies miniscrews
could be placed using a CTA, the authors of both studies
placed miniscrew implants only in the attached or unat-
tached buccal mucosa of the maxilla and the mandible,
areas where topical anesthetics are most effective.18 It is
doubtful whether a CTA would be as effective if used on
the thick keratinized tissue of the palate. In our study,
the absorption of the CTA into the surrounding tissues
appeared to limit its effectiveness. We observed that in
some patients the topical anesthetic was fully absorbed,
but in others most of the original amount of the topical
gel was still on the mucosa after 2.5 minutes. We also
found that patients remembered the same pain level
they experienced from the miniscrew placement even af-
ter 1 month. After completing the study, the patients
commented that they would prefer to have the injection
if given the choice in the future. By using an anesthetic
with inadequate pain control, the orthodontist risks hav-
ing the patient experience more overall pain during
treatment, possibly resulting in less motivation and
compliance during treatment. We found that the use
of a CTA did not provide adequate pain management
for placing miniscrews for orthodontic anchorage.
Based on our results, using only a CTA when placing
miniscrews is not as effective as a local injection of anes-
thetic to control patient discomfort. The pain perceived
by the patients was well recalled 1 month later. The suc-
cess rate of comfortably placing miniscrews with only a
CTA was relatively low.
Limitations
Clinical studies that provide good-quality patient
care while testing alternative treatments by their very
nature must involve some compromises. One limitation
January 2016  Vol 149  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Lamberton et al
of our study was not blinding the operator who in-
jected the anesthetic, the operator who placed the
miniscrew, or the patient to the type of anesthetic
used. However, significant operator or patient blinding
was impossible, while maintaining the clinical applica-
bility of the study. The CTA and the injection are
completely different clinical anesthetic delivery
methods and would have been difficult to blind. Use
of another clinician for data analysis, other than the
one who delivered the anesthetics, may have added
additional blinding, even though only random numbers
were used to identify patients during data analysis.
Another limitation of our study was that tissue type,
thickness, and location were not included as variables.
Because these factors could influence the rate and
amount of absorption of the CTA, future research
should include different tissue types as a consideration.
Future research could also include other delivery
methods of local anesthetic compared with an injection
of local anesthetic. Both the Syrijet (Keystone Industries,
Gibbstown, NJ) and the MadaJet XL (Mada, Carlstadt,
NJ) are needleless injectors of local anesthetic that are
commonly used before routine dental procedures. If
these devices provide a comfortable application of anes-
thetic as well as profound anesthesia, they could be a
useful alternative, particularly in patients with a needle
phobia.
Generalizability
The generalizability of this study may be limited
because the trial was limited to only 1 center and only
1 clinician providing the local anesthesia. In addition,
the perception of pain varies between patients; this
can skew the results. However, in our study, the higher
pain level during miniscrew placement with the CTA
was significant enough to conclude that a CTA alone
does not provide adequate pain control.
CONCLUSIONS
1. Compound topical anesthetics provided less pre-
dictable, often inadequate, and less comfortable
local anesthesia than an injection of a local anes-
thetic for placing miniscrews in buccal sites.
2. The patient's recollection of pain experienced dur-
ing the miniscrew procedure for each anesthetic
used did not change after 1 month.
ACKNOWLEDGMENTS
We thank Rocky Mountain Orthodontics for the
donation of the miniscrews and all residents who partic-
ipated in this study.
Lamberton et al
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