RANDOMIZED CONTROLLED TRIAL

Effectiveness of 3 methods of anchorage

reinforcement for maximum anchorage in
adolescents: A 3-arm multicenter
randomized clinical trial
Jonathan Sandler,a Alison Murray,b Badri Thiruvenkatachari,c Rodrigo Gutierrez,d Paul Speight,e
and Kevin O’Brienf
Chesterfield, Derby, Manchester, and Sheffield, United Kingdom

Introduction: The objective of this 3-arm parallel randomized clinical trial was to compare the effectiveness of
temporary anchorage devices (TADs), Nance button palatal arches, and headgear for anchorage
supplementation in the treatment of patients with malocclusions that required maximum anchorage. This
trial was conducted between August 2008 and February 2013 in 2 orthodontic departments in the United
Kingdom. Methods: The study included 78 patients (ages, 12-18 years; mean age, 14.2 years) who needed
maximum anchorage. Eligibility criteria included no active caries, exemplary oral hygiene, and maximum
anchorage required. Outcome: The primary outcome was mesial molar movement during the period in
which anchorage supplementation was required. The secondary outcomes were duration of anchorage rein-
forcement, number of treatment visits, number of casual and failed appointments, total treatment time,
dento-occlusal change, and patients' perceptions of the method of anchorage supplementation.
Randomization: Treatment allocation was implemented by contacting via the Internet the randomization
center at the University of Nottingham, Clinical Trials Unit. The randomization was based on a computer-
generated pseudo-random code with random permuted blocks of randomly varying size. Blinding: A
research assistant who was blinded to the group allocation recorded all data. Intervention: The patients
were randomly allocated to receive anchorage supplementation with TADs, a Nance button on a palatal
arch, or headgear. They were all treated with maxillary and mandibular preadjusted edgewise fixed appli-
ances with 0.022-in slot prescription brackets. They were followed until orthodontic treatment was
complete. Results: Seventy-eight patients were randomized in a 1:1:1 ratio among the 3 groups. The baseline
characteristics were similar in the groups, and they were treated for an average of 27.4 months (SD, 7.1
months); 71 completed orthodontic treatment. The data were analyzed on a per-protocol basis and showed
no differences in the effectiveness of anchorage supplementation between TADs, Nance button palatal
arches, and headgear. Compared with headgear, the average mesial movements of the maxillary right
molar were 0.62 mm ( 0.32 to 1.55 mm) with the Nance and 0.58 mm ( 1.53 to 0.36 mm) with TADs; the
maxillary left molar was moved 0.09 mm ( 1.00 to 0.83 mm) with the Nance and 0.96 mm ( 1.89 to
0.04 mm) with the TADs. Peer assessment rating scores were significantly better with the TADs than in
the headgear and Nance groups. The patient questionnaires showed that comfort levels on placement of
the TADs and the Nance were similar. Headgear was more troublesome and less popular with the patients.
Conclusions: There was no difference in the effectiveness between the 3 groups in terms of anchorage
support. There were more problems with the headgear and Nance buttons than with the TADs. The quality
of treatment was better with TADs. As a result, TADS might be the preferred method for reinforcing ortho-
dontic anchorage in patients who need maximum anchorage. Trial registration: ClinicalTrials.gov Identifier:
a
Consultant orthodontist, Chesterfield Royal Hospital, Chesterfield, United Sandler is a consultant for American Orthodontics, involved in product evalua-
Kingdom. tion and lectures. American Orthodontics provides support for courses given
b
Consultant orthodontist, Royal Derby Hospital, Derby, United Kingdom. by Jonathan Sandler, Alison Murray, and Kevin O'Brien. No other conflicts
c
NIHR Academic Clinical Lecturer, School of Dentistry, University of Manchester, were reported.
Manchester, United Kingdom. Funded by the British Orthodontic Society Foundation.
d
Oral surgery trainee, Royal Derby Hospital, Derby, United Kingdom. Address correspondence to: Jonathan Sandler, Chesterfield Royal Hospital,
e
Professor, School of Clinical Dentistry, University of Sheffield, Sheffield, United Calow, Chesterfield S445BL, United Kingdom; e-mail, JonSandler57@gmail.
Kingdom. com.
f
Professor, School of Dentistry, University of Manchester, Manchester, United Submitted, November 2013; revised and accepted, March 2014.
Kingdom. 0889-5406/$36.00
All authors have completed and submitted the ICMJE Form for Disclosure of Copyright Ó 2014 by the American Association of Orthodontists.
Potential Conflicts of Interest, and the following were reported: Jonathan http://dx.doi.org/10.1016/j.ajodo.2014.03.020

10
Sandler et al 11

NCT00995436. Protocol: The protocol was published on the above site before the trial commencement.
Funding: The British Orthodontic Society Foundation funded the study and American Orthodontics provided
all the TADs and associated equipment. (Am J Orthod Dentofacial Orthop 2014;146:10-20)

I
n this article, we present the results of a randomized MATERIAL AND METHODS
controlled trial investigating the effectiveness of Trial design
methods of anchorage reinforcement for orthodon-
tic treatments requiring maximum anchorage. When This 3-arm parallel group randomized clinical trial
the evidence base underpinning this type of treatment had a 1:1:1 allocation ratio.
is critically examined, the level of evidence is not high.
For example, when we reviewed recently published tri- Participants, eligibility criteria, and settings
als as part of a Cochrane Review we found 7 publica- Participants were recruited at 2 hospital orthodontic
tions.1-7 Of these, 1 study suggested that headgear departments in the United Kingdom, Chesterfield Royal
and midpalatal implants were equally effective in Hospital and Royal Derby Hospital, and treated by 2 cli-
providing anchorage,1 whereas another large study nicians (J.S. and A.M.), both of whom have wide experi-
found in favor of surgically assisted anchorage.2 Inter- ence with the treatment methods. The clinicians were
estingly, both studies used palatally placed osseointe- salaried hospital employees, and all treatments were pro-
grated surgical anchorage devices. Two further vided within the United Kingdom's National Health Ser-
studies evaluated temporary anchorage devices vice at no direct cost to the patient or family. The study
(TADs), comparing them with conventional anchorage, was approved by the Central Research Ethics Committee
such as headgear, palatal arches, and banding of sec- and the research and development departments at Ches-
ond molars.3,4 These studies concluded that TADs terfield Royal Hospital and Royal Derby Hospital Na-
were more effective than other methods of anchorage tional Health Service trusts. A data-monitoring
supplementation. committee was established, and annual reports were
When we consider any form of orthodontic treat- submitted to this committee throughout the study to
ment, it is essential to study the patients' perceptions, reassure them that progress was being made and that
since their values can differ between treatment methods. any untoward effects were reported. The trial was regis-
Unfortunately, this has only been considered in a few tered at ClinicalTrials.gov Identifier: NCT00995436, and
studies evaluating anchorage supplementation.5-7 This the protocol was published on that site before the trial.
information has been confined to the patients' We followed the guidelines in the declaration of Hel-
perception of pain or discomfort associated with sinki.8
implant placement or removal. They reported that the The study was carried out with 78 patients. To be
placing and removal of midpalatal implants and included, patients had to be between 12 and 18 years
onplants are uncomfortable, requiring extensive local old. The operators had assessed them as needing
anesthesia and often postsurgery analgesia, compared maximum anchorage. This was defined as “no mesial
with the relatively simple procedures of placement and movement of the molars during the period of anchorage
removal of TADs. supplementation.” No attempt was made to achieve
We therefore decided to investigate the effectiveness distal molar movement because clinically this was not
of 3 methods of anchorage supplementation, with a required.
group of patients defined as needing maximum The exclusion criteria for the study were patients who
anchorage, and report on both orthodontists' and pa- (1) required functional appliance therapy or orthog-
tients' values. nathic surgery, (2) had previous orthodontic treatment
We tested the hypothesis that there is no difference in or extractions, (3) had hypodontia of more than 1 tooth
the effects of TADs, headgear, and Nance button palatal per quadrant, (4) had craniofacial syndromes or clefts,
arches when used to reinforce orthodontic anchorage and (5) had poor dental health precluding orthodontic
with respect to (1) the amount of molar tooth move- treatment.
ment, (2) the duration of treatment, (3) the number of
treatment visits, (4) the total treatment time, (5) Interventions
dento-occlusal changes (peer assessment rating [PAR] All patients were fitted with McLaughlin, Bennett,
index), and (6) the patients' perceptions of the Trevisi prescription (American Orthodontics, Sheboy-
treatment. gan, Wis) maxillary and mandibular preadjusted

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12 Sandler et al

springs ligated directly from the canine to the TAD to

produce 90 to 100 g of force.
All patients were treated similarly, with a standard
archwire sequence (0.016-in Sentalloy, 0.018 3 0.025-
in Neo-Sentalloy, and 019 3 0.025-in stainless steel),
and the canines were retracted to achieve a Class I canine
relationship before complete overjet reduction and space
closure. Anchorage supplementation was discontinued
once the canines were Class I and there was sufficient
space in the maxillary arch to complete the correction
of the malocclusion. At this point, the operator judged
that no further anchorage supplementation was needed;
Fig 1. Sectional fixed appliances to fully align maxillary therefore, the headgear was stopped, and the TADs or
molars before DC1 records. the acrylic Nance button was removed.

edgewise fixed appliances. During the initial phase of Outcomes, primary and secondary
treatment, we derotated the molars in all 3 treatment The primary outcome measure in this study was
groups. This involved bracket placement on all premo- movement of the molars. The following secondary
lars and molars in the maxillary buccal segments and outcome measures were collected from the patients'
working through 3 archwires (0.016-in Sentalloy treatment records.
[Dentsply, GAC, Bohemia, NY], 0.018 3 0.025-in
1. The process of treatment (number of attendances,
Neo-Sentalloy, and 0.019 3 0.025-in stainless steel
duration of treatment, number of missed and
[American Orthodontics]) until the molars were aligned
canceled appointments, and any emergency ap-
(Fig 1). At this point, the first data collection (DC1)
pointments).
records were taken.
2. The dento-occlusal outcome of treatment using the
We observed the following treatment protocols.
PAR index with the United Kingdom weightings.9
For the headgear patients, this was a pragmatic trial,
Calibrated dental technicians, blinded to treatment
and all operators determined the design of the headgear
allocation, performed this.
according to their current treatment protocols. They
placed 250 g of force per side on the headgear bow In addition, the patients were given questionnaires
and requested at least 100 hours of headgear wear per about the comfort and discomfort levels of placement
week from the patients. We asked them to fill in a diary and removal of both TADs and Nance palatal arches during
of headgear wear throughout treatment. The clinician the week after the procedure. The headgear patients only
checked both the headgear force and the compliance completed a questionnaire about their clinical experiences.
with headgear charts at each visit. Extractions were per- There were no outcome changes after commence-
formed once the headgear was fitted. ment of the trial.
For the Nance button patients, molar bands were The data were collected at the following time points:
fitted, and an alginate impression was taken over the at the start of full arch treatment when anchorage sup-
bands; a Nance button on a 1.0-mm stainless steel plementation was provided (DC1), when anchorage sup-
palatal arch was made by an orthodontic technician. A plementation was no longer required (DC2), and when
large Nance button was used to cover the entire vertical active orthodontic treatment was complete (DC3). The
part of the hard palate. This was fitted 1 week later, and following were collected: (1) maxillary and mandibular
any required extractions were arranged. silicone impressions (DC1, DC2, DC3); (2) photographs,
For the TADs patients, the maxillary and mandibular 4 extraoral and 5 intraoral (DC1, DC3), and intraoral
fixed appliances were placed, and arrangements were (DC2); (3) orthopantomogram images (DC1, DC3); (4)
made for the necessary extractions before the TADs TADs questionnaire (2 weeks after placement and 2
were placed. On the sides requiring anchorage supple- weeks after removal); (5) Nance questionnaire (2 weeks
mentation, 8 3 1.6-mm TADs (American Orthodontics) after placement and 2 weeks after removal); (6) headgear
were placed under local anesthesia, usually at the junc- questionnaire (2 weeks after headgear was stopped); and
tion of the attached gingivae with the reflected mucosa (7) PAR scores (DC1, DC3).
and mesially to the maxillary molars. The TADs were Data collected from patient notes included (1) num-
placed before any retraction force was placed on the ca- ber of attendances; (2) number of visits from DC1 to DC2
nines. Retraction was carried out with nickel-titanium and from DC2 to DC3; (3) duration of overall treatment;

July 2014  Vol 146  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Sandler et al 13

(4) number of missed or canceled appointments; and (5)

frequency and reason for additional appointments for
appliance breakage.
To make sure that the study models taken at DC2 did
not provide information on the treatment allocation, we
did the following. In the Nance group, the palatal arch
was cut away from the bands, and the acrylic Nance but-
ton removed 2 weeks before the DC2 records were taken.
This allowed any inflammation of the palatal tissues to
subside and normal anatomy to reestablish. In the
TADs group, the TADs were also removed before the im-
pressions were taken.
To allow 3-dimensional (3D) digital scans of the
models to be produced, the study models were sent to Fig 2. Blue “mushroom” covering points of known stabil-
Bioprecision Diagnostics (Yeovil, Somerset, United ity for regional superimpositions.
Kingdom), where they were scanned by a 3Shape scanner
(www.3shape.com) using 3Shape Scanserver and 3Shape
ScanItOrthodontics software packages (3Shape, Copen-
hagen, Denmark). Surface shape measurements of the
models were recorded through triangulation, and the
computer then converted this information into a 3D
polygon mesh. The detailed scans were trimmed using
another software (Rhinoceros CAD; McNeel Europe, Bar-
celona, Spain; www.rhino3d.com).
We measured tooth movement using Rapidform
2006 (Geomagic, Rock Hill, SC) software that allowed
superimposition of the DC1 and DC2 maxillary 3D digital
models, using the iterative closest point algorithm. This
is a minimization routine, whereby many iterations of
the superimposition process are performed within 6 de-
grees of freedom. On the pitch, yaw, and roll axes, the Fig 3. Color of the model represents the accuracy of the
superimposition.
models can either translate or rotate, until the computer
successfully minimizes the sum of the squares of the
Sample size calculation
Euclidean distances between corresponding points on
the 3D digital models at DC1 and DC2. The computer Calculation of the sample size was based on the abil-
is directed to base the superimposition on an area of ity to detect a clinically relevant difference in anchorage
known stability common to both the DC1 and DC2 loss of 1.5 mm between 2 of the treatment groups. The
models; we selected this as the blue mushroom-shaped expected standard deviation of mesial molar movement
area based on the palatal rugae and a stable area of was taken from the study of Luecke and Johnstone,10
the hard palate shown in Figure 2. The precision of the who investigated molar movement in premolar extrac-
superimposition was assessed by the color of the models; tion patients when anchorage was supplemented with
the blue part of the spectrum indicates almost perfect headgear. The calculation indicated that for a study
superimposition of the 2 areas that are common to with a power of 80% and an alpha of 0.05, we required
both digital models (Fig 3). 21 participants per group. We assumed a dropout rate of
The DC1 maxillary molar outlines were then selected 20%, based on a previous study suggesting that a min-
(Fig 4). The software constructed a DC1 molar shell, and imum of 75 patients was required.5 nQuery Advisor sta-
this molar shell was superimposed on the DC2 molar tistical software (Statistical Solutions, Boston, Mass) was
occlusal surface, using best-fit algorithms. Tooth move- used for the actual calculation.
ment was calculated by measuring the difference in po-
sition of the DC1 and DC2 centers of mass (Fig 5). Interim analyses and stopping guidelines
A research assistant (R.G.) who was blinded to treat- No interim analyses were planned, and the data-
ment allocation made the superimpositions and mea- monitoring committee was happy with our progress
surements of tooth movement. throughout the study.

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14 Sandler et al

Fig 4. Models rotated to allow the entire occlusal, buccal, and palatal surfaces to be highlighted.

Fig 5. Movement of maxillary right molar shell and measurements in all 3 planes.

Randomization (random number generation, procedures. When the patient and the parent had con-
allocation concealment, implementation) sented to be in the study, the randomization center at
Randomization (random number generation, alloca- the University of Nottingham Clinical Trials Unit was con-
tion concealment, implementation) was done as follows. tacted. Demographic data were entered; after confirma-
When we identified patients who satisfied the inclusion tion of the veracity of the data, the group allocation was
criteria, we asked them to take part in the trial. Once indicated. Twenty-seven patients were randomized to
informed consent was obtained from either competent the TADs group, 26 to the Nance group, and 25 to the
patients or their parents, the orthodontist accessed the headgear group. At DC2, we analyzed 22 TADs patients,
University of Nottingham Clinical Trials Unit randomiza- 26 Nance patients, and 23 headgear patients (Fig 6).
tion service (http://www.ctsu.nottingham.ac.uk/0822/
login.asp) to obtain a treatment allocation. This ensured Blinding
separation of the recruitment and randomization pro- The clinicians and the patients were blinded to the
cesses. allocation sequence; however, it was impossible to blind
The randomization was based on a computer- them to the treatment method. Assessment was blind
generated pseudorandom code with random permuted because it was impossible to distinguish between the
blocks of randomly varying sizes. The sequence was held groups, since the Nance and the TADs had been removed
on a secure server according to standard operating before the DC2 records were taken.

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Sandler et al 15

Fig 6. CONSORT 2010 flow diagram.

Statistical analysis A similar analysis was carried out for the secondary
A double determination was performed on 20 pairs of outcome measures; the dependent variables were total
superimposed digital models. The study models were treatment time, total number of visits, number of missed
randomly picked and analyzed at 2 time points 4 weeks and canceled appointments, and dento-occlusal changes
apart. as measured by PAR scores. When it was relevant, the pre-
Bland-Altman plots,11 intraclass correlation coeffi- treatment PAR score was fitted as a covariate.
cients, and paired t tests were used to assess reliability. The SPSS software package was used (version 21;
Summary statistics were calculated for the data at the SPSS, Chicago, Ill), and statistical significance was set
start and finish points of the study. We checked the var- at the 5% level.
iances of the molar movements for normality; when they RESULTS
were found to be normally distributed, parametric tests
were appropriate. Participant flow
A per-protocol analysis was performed. All patients in Ninety patients were initially informed about the
the study either were included in the data analysis or, if study, and 12 declined to enter. Three did not want to
they had dropped out, were reported on individually. wear headgear, 3 did not want the Nance button, but
The data were analyzed with analysis of covariance only 1 patient did not want to take part because he or
(ANCOVA), with headgear as the reference group and she was unhappy at “the thought of TADs.” The other
molar movement at DC2 as the dependent variable. The in- 5 patients had personal reasons for not wanting to
dependent variables were the treatment groups (Nance, take part in a research study. All patients who declined
headgear, and TADs). Because the groups were unbalanced were offered alternative treatments.
in their sex distributions after randomization, we also fitted Of the 78 patients enrolled, 27 were allocated to
sex as a covariate to adjust for the baseline scores. TADs (16 girls, 11 boys; average age, 14.15 years; SD,

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16 Sandler et al

Table I. Sample summary statistics at start of treatment, by treatment group, and for total sample
Patient details Headgear Nance TADs Total
Age (y) 14.38 (1.67) 14.14 (1.48) 14.15 (1.25) 14.22 (1.46)
n 5 25 n 5 26 n 5 27 n 5 78
PAR score 33.13 (13.40) 36.92 (12.52) 34.86 (13.39) 35.06 (12.99)
n 5 23 n 5 26 n 5 22 n 5 71
SNA ( ) 80.99 (3.43) 81.40 (5.13) 82.12 (3.31) 81.51 (4.06)
n 5 23 n 5 26 n 5 24 n 5 73
Girls (n, %) 14/25 (56%) 7/26 (27%) 16/27 (59%) 37/78 (47%)
Values are mean (SD).

that included zero. The R2 values were also small, signi-

Table II. Molar tooth movements
fying that the model explained a small amount of the
Headgear Nance TADs variation. As a result, we concluded that no method of
Outcome (n 5 23) (n 5 26) (n 5 22) anchorage supplementation was more effective than
Maxillary right molar (z) (mm) 1.36 (1.83) 1.84 (1.32) 0.80 (1.60) another.
Maxillary left molar (z) (mm) 1.99 (2.09) 2.09 (1.32) 0.99 (1.15)
Table IV includes information on the total treatment
Values are mean (SD). time and the number of visits. Table V contains the linear
z, Mesiodistal movement of the molar teeth.
regression on these variables, showing that there were no
significant differences between the 3 groups. The
1.25 years), 26 to Nance (7 girls, 19 boys; average age, numbers of canceled and missed appointments were
14.14 years; SD, 1.48 years), and 25 to headgear (14 almost identical between the groups.
girls, 11 boys; average age, 14.38 years; SD, 1.67 years). Dento-occlusal changes, measured by the PAR index,
The first patient was enrolled on August 5, 2008, and the are shown in Table VI. The linear regression models for
final patient was enrolled 28 months later on December the effects of treatment on the posttreatment PAR scores
22, 2010. All treatments were completed by February are shown in Table VII. The analysis shows a significant
2013. Two headgear patients and 5 TADs patients effect (P 5 0.05): the TADs group was 4 PAR points
dropped out during the treatment period. The headgear lower than the headgear group.
patients were unable to cooperate with their treatment.
The patients allocated to the TADs group stopped treat- Reproducibility of the method
ment for various social and domestic reasons. No patient An error analysis was performed on 20 pairs of super-
who dropped out had reached the stage of having the imposed digital models. The models were selected using
TADs placed. a computer-based random-number generator. The in-
The flow of patients through the study is shown in traclass correlation coefficients ranged from 0.94 to
Figure 6. No dropout patient reached a stage where 0.97, and systematic errors assessed with the Bland-
the DC2 records could be taken. Altman plots11 included no clinically important discrep-
ancies. This demonstrated that the method of recording
Baseline data data had a high level of reliability, and any method errors
At baseline, information regarding age, sex, starting were acceptable.
PAR score, and maxillary prominence was collected.
Summary statistics for the patients are included in Patient perceptions
Table I. The baseline characteristics were similar in the Table VIII contains data from the 6-point Likert scale
3 groups at the start of treatment. There was a lower pro- that measured the patients' perceptions of discomfort,
portion of girls in the Nance group compared with the with 1 representing “uncomfortable” and 6 “comfort-
other 2 groups. able.” The scores between the Nance button palatal
arches and the TADs both on placement and on removal
Molar tooth movement were almost identical. Free text comments were almost
The amounts of molar movement are shown in Table always positive with TADs; 17 of the 22 patients reported
II, and the results of the data analysis are included in no problems, and 20 would recommend this method to
Table III. This showed that the differences between the their peers. The Nance free text session listed a number
treatments were small, with wide confidence intervals of minor problems, and 20 of the 26 patients in the

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Sandler et al 17

Table III. ANCOVA models for the effects of treatment on molar tooth movement measured on digital models
Outcome Effect of treatment (95% CI)* Overall effect of treatment R2 Covariate
Maxillary right molar (z) mm Nance, 0.62 ( 0.32 to 1.55) TADs, 0.58 ( 1.53 to 0.36) F (2, 67) 5 3.10; P 5 0.05 0.07 Sex
Maxillary left molar (z) mm Nance, 0.09 ( 1.00 to 0.83) TADs, 0.96 ( 1.89 to 0.04) F (2, 67) 5 2.58; P 5 0.08 0.09 Sex
z, Mesiodistal movement of the molar teeth; F, level of significance P 5 0.05.
*Reference category is headgear.

Table IV. Total treatment time and number of visits from the initial placement of appliances to debond of all attach-
ments
Process of treatment Headgear (n 5 23) Nance (n 5 26) TADs (n 5 22) Total (n 5 71)
Total treatment time (mo) 28.01 (17.46-38.51) 27.43 (15.03-39.83) 26.83 (8.5-45.16) 27.42 (13.5-41.34)
Total visits (n) 19.24 (6.66-31.8) 21.77 (13.13-30.41) 18.38 (5.8-30.04) 19.84 (8.57-31.11)
Values are mean (95% confidence interval).

Table V. ANCOVA models for total treatment time and number of visits during treatment
Outcome Effect of treatment (95% CI)* Overall effect of treatment R2 Covariate
Total treatment time (mo) Nance, 0.58 ( 4.68 to 3.52) TADs, 1.18 ( 5.41 to 3.04) F (2, 69) 5 0.16; P 5 0.87 0.01 None
Total visits (n) Nance, 2.53 ( 0.62 to 5.68) TADs, 0.87 ( 4.08 to 2.35) F (2, 72) 5 2.47; P 5 0.09 0.06 None
F, Level of significance P 5 0.05.
*Reference category is headgear.

During the first 3 days of Nance appliance wear, the

Table VI. Start and finish PAR scores for the 3 groups
score was at the comfortable end of the scale, and the
and reduction of PAR scores
discomfort lasted just over 2.5 days. On removing the
PAR Headgear Nance TADs Total Nance, similarly positive scores were recorded for com-
scores (n 5 23) (n 5 26) (n 5 22) (n 5 71) fort.
Start 33.13 (13.40) 36.92 (12.52) 34.86 (13.39) 35.06 (12.99)
Twenty of the Nance patients indicated that they had
Finish 11.91 (7.39) 11.38 (5.73) 8.27 (4.13) 10.59 (6.04)
Reduction 21.26 (10.61) 25.69 (11.47) 26.59 (13.82) 24.54 (12.04) no problems with the appliance, whereas the remaining
6 mentioned gum irritation or inflammation, problems
Values are mean (SD). with cleaning, or food getting under the arch. Despite
this, 24 of 26 said that they would recommend this
group reported no problems; 24 would recommend this method to a friend.
anchorage method to their peers. The TADs group scored the level of comfort on place-
ment and over the first 3 days as similar to the group with
Questionnaires the Nance button palatal arch. On removal of the TADs,
The headgear questionnaire data are shown in Table comfort was also scored similarly to removal of the Nance.
IX. On average, the headgear was worn for 3 hours less Most patients (20 of 22) would recommend this method
than requested and for just less than 10 months. Head- of anchorage supplementation to their friends.
gear was scored on the negative end of the scale for The free text responses were also valuable in giving
comfort and convenience, and 13 of the 23 patients insight into the patients' perceptions. Seventeen pa-
would recommend this method of anchorage supple- tients recorded no problems. When asked whether they
mentation. experienced any problems after placement of the
When asked specifically whether they had problems TADs, 1 respondent noted that 1 TAD became loose,
with headgear, only 3 patients mentioned that headgear and another reported occasional discomfort.
interfered with sleep, and another 3 mentioned some
pain, discomfort, or rubbing experienced while wearing Extractions
the headgear; 3 comments suggested that the headgear All patients in the study needed maximum
made them self-conscious or embarrassed. anchorage, implying that no mesial movement of the

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18 Sandler et al

Table VII. ANCOVA model for the effects of treatment on the PAR score at finish
Outcome Effect of treatment (95% CI)* Overall effect of treatment R2 Covariate
PAR finish Nance, 1.24 ( 4.36 to 1.89) TADs, 3.97 ( 7.20 to 0.73) F (2, 67) 5 3.13; P 5 0.05 0.23 PAR start

F, Level of significance P 5 0.05.

*Reference category is headgear.

Table VIII. Questionnaire results about comfort on placement and removal

Comfort during Discomfort Discomfort Discomfort
Anchorage method Placement comfort first 3 days days (n) Removal comfort after 3 days duration (days)
TADs 4.41 (1.1) 3.73 (1.55) 2.82 (2.11) 4.25 (1.41) 4.81 (1.54) 1.00 (1.4)
Nance 4.62 (1.3) 3.46 (1.48) 2.65 (2.04) 4.31 (1.44) 4.92 (1.06) 1.12 (1.73)
These data were derived from the 6-point Likert scale measuring the patients' perceptions of discomfort, with 1 representing uncomfortable and 6
representing comfortable. Values are mean (SD).

Table IX. Questionnaire results about headgear wear, comfort, and convenience
Headgear Hours requested Hours actually worn Months Comfort Convenience Social interference Did it bother you?
Mean 13.87 10.87 9.89 2.87 2.91 3.78 2.76
SD 3.31 4.01 4.73 1.39 1.41 1.51 1.55
These data were derived from the 6-point Likert scale, with 1 representing a large negative effect and 6 representing little effect or comfort.
Values are mean (SD).

Importantly, no method prevented the mesial movement

Table X. Extraction patterns of the maxillary molars.
Maxillary first premolars 38 Our results do not agree with those reported in previ-
Maxillary first and mandibular second premolars 9 ous studies that demonstrated less loss of anchorage
4 first premolars 7 with surgically assisted methods.2,12 However, in these
1 first and 3 second premolars 5
1 first premolar and 1 other tooth 3 studies, the authors used osseointegrated midpalatal
1 first premolar and 3 other teeth 3 implants or onplants, which might be more effective
4 first molars 3 than the methods we evaluated. Another study
Other extraction pattern 9 reported similar anchorage losses to ours; however, the
No extractions 1
study was underpowered, and the difference between
the 2 groups was not statistically significant.1
molars would be acceptable. Clearly, there was a space Distal molar movement when using TADs in patients
requirement in all patients, and several extraction pat- needing maximum anchorage has also been reported in
terns were adopted (Table X). a number of studies.3,4,13 It is relevant to consider that
Harms these studies all used cephalometric measurements,
with inherent errors of projection, patient positioning,
We found no serious harms from the treatments. The magnification, and imprecise landmarks involving
only adverse effect was that 1 TAD fractured on place- averaging of superimposed structures. Our method for
ment; the fractured fragment, after consultation with measuring tooth movement might have been more
the patient, the parent, and the oral surgeon, was left accurate.
in place. Healing was uneventful. We considered the potential biases in previous
DISCUSSION research. In 1 study, the assessor was not blinded to
the treatment method.3 In none of 6 studies was an
Main findings in the context of the existing attempt made to differentiate between the left and right
evidence, interpretation molars; this could have led to errors in interpretation and
The results of this study showed no clinically or sta- measurement.2-5,12,13
tistically significant differences in the effectiveness of The sex imbalance was taken into account in the sta-
the 3 methods of anchorage supplementation. tistical analysis, and this made no difference in the results.

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Sandler et al 19

There were no dropouts from the Nance group and Although there were no difference between the effec-
only 2 from the headgear group. In the TADs group, tiveness of TADS and Nance treatments, this information
however, there were 5 dropouts; all occurred before should be given to patients along with the description of
the TADs had been fitted. Although the number in this the treatment process so that they can make an informed
group was still above the sample size, it could be sug- choice of their preferred treatment. This study provides
gested that this introduced a moderate risk of attrition clinically relevant information that will aid orthodontists
bias. and patients in determining the optimum form of
Secondary outcome measures in this study included anchorage reinforcement.
treatment time and number of visits. We found that the The failure rate of TADs in this study was 2.8%, which
overall treatment times were similar to other studies.1,5 is significantly lower than the 12% failure rate reported
It is also clear, from reviewing other studies in this elsewhere.14
area, that few investigators have reported the final out-
comes of treatment.2-4,6,10,12,13 Therefore, we evaluated Limitations
the final occlusal result of the treatment with the PAR In this study, it was not possible to blind the opera-
index. This analysis showed a clinically and statistically tors and patients to the treatment allocations. Neverthe-
significant difference between the TADs and the less, the assessment of the outcomes was blinded, and
headgear groups. The only other study that previously we considered that the risks of observation and detection
investigated this outcome reported no difference in the bias were low. We think that attrition bias might be an
PAR scores for midpalatal implant and headgear issue, however, because more patients dropped out of
treatments; this is different from our results.5 It is diffi- the study in the TADs group. This could be interpreted
cult to identify the reasons for this finding; it might as the patients' possible reluctance to accept the surgical
reflect the natural variability between studies. placement of TADs.
We found some important and interesting results
from the patient perception questionnaires. First, there Generalizability
were no marked differences in the perceptions of the pa-
tients who had been treated with the TADs or the Nance The external validity or generalizability of this study
palatal arches. This suggests that the 2 interventions is good. It was carried out at 2 district general hospitals
were equally acceptable to patients. by experienced clinicians. The patients were selected
When we considered the perceptions of the headgear from the normal caseloads of the departments, and all
patients, it was interesting that the average hours of re- received routine care.
ported wear were 3 hours less than the minimum of 14
hours that we requested. Five patients reported that CONCLUSIONS
they thought that the headgear only needed to be worn We can conclude the following: (1) there was no dif-
for half of a day. This demonstrates that even with careful ference in the effectiveness of TADs, Nance button
planning and explanations of treatment, mixed messages palatal arches, and headgear for reinforcing anchorage
can still arise, and full cooperation is not always forth- during orthodontic treatment; and (2) the information
coming. Although this level of cooperation could be from this study can be used to help orthodontists and
considered disappointing, this was a pragmatic study, patients determine their preferences for the method of
and we are reporting on treatment of real-world patients anchorage reinforcement.
whose behavior is relevant to practice.
Whereas there were few real differences in the scores ACKNOWLEDGMENTS
from the Likert scales, the free text sections showed
important clinically relevant findings, and it was clear We thank all patients and parents who contributed to
that patients preferred not to wear headgear. this study, the supporting staff at both treatment cen-
This study adds to the body of evidence that TADs are ters, Tanya Walsh for her statistical input, and American
an efficient and effective method of supplementing Orthodontics (Sheboygan, Wis) for providing the im-
anchorage. Although there were no differences between plants and associated equipment.
the 3 interventions in terms of reinforcing anchorage, it
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