Journal of Orthodontics, Vol.

38, 2011, 3239

SCIENTIFIC SECTION

Alignment efficiency and discomfort of three orthodontic archwire sequences: a randomized clinical trial
Emily Ong
University of Queensland Dental School, Brisbane, Australia

Christopher Ho
University of Queensland Dental School, Brisbane, Australia Royal Childrens Hospital, Brisbane, Australia

Peter Miles
Private Practice, Caloundra, Australia University of Queensland Dental School, Brisbane, Australia

Aim: To compare the efficiency of orthodontic archwire sequences produced by three manufacturers. Design: Prospective, randomized clinical trial with three parallel groups. Setting: Private orthodontic practice in Caloundra, QLD, Australia Subjects and methods: One hundred and thirty-two consecutive patients were randomized to one of three archwire sequence groups: (i) 3M Unitek, 0.014 inch Nitinol, 0.017 inch60.017 inch heat activated NiTi; (ii) GAC international, 0.014 inch Sentalloy, 0.01660.022 inch Bioforce; and (iii) Ormco corporation, 0.014 inch Damon Copper NiTi, 0.01460.025 inch Damon Copper NiTi. All patients received 0.01860.025 inch slot Victory SeriesTM brackets. Outcome measures: Mandibular impressions were taken before the insertion of each archwire. Patients completed discomfort surveys according to a seven-point Likert Scale at 4 h, 24 h, 3 days and 7 days after the insertion of each archwire. Efficiency was measured by time required to reach the working archwire, mandibular anterior alignment and level of discomfort. Results: No significant differences were found in the reduction of irregularity between the archwire sequences at any timepoint (T1: P50.12; T2: P50.06; T3: P50.21) or in the time to reach the working archwire (P50.28). No significant differences were found in the overall discomfort scores between the archwire sequences (4 h: P50.30; 24 h: P50.18; 3 days: P50.53; 7 days: P50.47). When the time-points were analysed individually, the 3M Unitek archwire sequence induced significantly less discomfort than GAC and Ormco archwires 24 h after the insertion of the third archwire (P50.02). This could possibly be attributed to the progression in archwire material and archform. Conclusions: The archwire sequences were similar in alignment efficiency and overall discomfort. Progression in archwire dimension and archform may contribute to discomfort levels. This study provides clinical justification for three common archwire sequences in 0.01860.025 inch slot brackets. Key words: Orthodontics, RCT, archwires, alignment
Received 6th October 2010; accepted 16th November 2010

Introduction
The selection of efcient archwire sequences is fundamental to orthodontic treatment. Clinicians are faced with a bewildering array of commercially available orthodontic archwires on a daily basis.1 The paucity of in vivo evidence that provides a clinical rationale for archwire sequencing is disquieting. Most of our knowledge of orthodontic archwires has been derived from in vitro studies. However, these bench properties cannot completely predict the clinical performance of archwires. A recent systematic review was
Address for correspondence: Peter Miles, University of Queensland Dental School, Brisbane, QLD, Australia. Email: pmiles@beautifulsmiles.com.au # 2011 British Orthodontic Society

unable to make any recommendations regarding the most effective aligning archwire due to insufcient in vivo data.2 Furthermore, a meta-analysis was not possible because the four clinical trials that were included used incongruent methodology.36 Only one in vivo study has investigated the efciency of archwires in a sequence. Mandall et al.7 compared three Ormco (Glendora, CA, USA) archwire sequences from initial alignment to the placement of the working archwire. They did not nd any signicant differences in efciency between the archwire sequences in terms of the time taken to reach the working archwire, patient discomfort, or the amount of root

DOI 10.1179/14653121141218

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Alignment with 3 archwire sequences: a RCT

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resorption induced. They concluded that the rationale for archwire selection varies according to the clinicians treatment philosophy and experience. Rock and Wilson8 suggested that the clinical efciency of an archwire sequence may be measured by the efciency of tooth movement with the minimization of iatrogenic damage and patient discomfort. The majority of orthodontic patients endure signicant levels of pain and discomfort during treatment. The pain induced from the placement of an archwire is reportedly more intense and of longer duration than that associated with a dental extraction.9 Discomfort may be inuenced by a number of factors including the force generated by the archwire, ligation technique, soft tissue ulceration, or difculties with mastication. This study aimed to compare the efciency of archwire sequences produced by three popular manufacturers; 3M UnitekTM (Monrovia, CA, USA), Ormco and GAC international (Bohemia, NY, USA). The null hypotheses were that there were no signicant differences between the archwire sequences in:

was employed, where patients were randomized in blocks of 12 to ensure equal allocation of patients to the treatment groups. Randomization was performed using computer generated numbers. A list of numbers was kept by the laboratory staff, who on the day of bracket placement would then assign them to the appropriate group, so the treating clinician was not involved. The patients were blinded to their group allocation throughout treatment; however, the treating clinician could not be masked. The three randomly allocated archwire sequences used in the mandibular arch were as follows: 1. 3M Unitek: Orthoform II archforms

N N N N N N

0.014 inch Nitinol 0.01760.017 inch heat activated NiTi

2. GAC International: Medium Ideal archform 0.014 inch Sentalloy 0.01660.022 inch Bioforce

N N N

time taken to reach the working archwire; discomfort experience; anterior mandibular arch alignment.

3. Ormco: Damon archform 0.014 inch Damon Copper NiTi 0.01460.025 inch Damon Copper NiTi.

Subjects and methods

Ethical approval was obtained from the University of Queensland Dental Sciences Research Ethics Committee on the 6/11/07 (project number 07/18).

Participants
Consecutive patients who attended the private orthodontic practice of one of the authors (PM, Caloundra, QLD, Australia) were asked to participate. All patients who required both upper and lower orthodontic appliances were included. There were no restrictions regarding age, previous orthodontic experience, or extraction/non-extraction treatment. No patients had craniofacial abnormalities. Patients were excluded if they had asymmetrically missing or extracted premolars, missing or unerupted lower incisors or canines, or teeth blocked out that did not allow for placement of all brackets at the initial bonding appointment. All patients were treated with 0.01860.025 inch Victory seriesTM MBT brackets (3M Unitek) by a single private orthodontist.

All three groups ended in the same working archwire, a 0.01660.022 inch stainless steel archwire of Orthoform II archform (3M Unitek) to produce a common endpoint. The patients were treated according to the clinicians usual treatment protocol. This involved ligation of the archwire with elastomeric modules and adjustment appointments scheduled every 10 weeks. Archwires were left in place until the clinician determined that the next archwire in the sequence could be completely engaged. The time interval to the next appointment was reduced where necessary to enable efcient archwire progression. Anterior mandibular polyvinyl siloxane impressions were taken of each patient at the following time-points: T1: T2: T3: placement of fixed appliances and first archwire; removal of first archwire and placement of second archwire; removal of second archwire and placement of working archwire.

Blinding
The clinicians staff assigned an identication number to each model prior to measurement in order to mask the principal researcher (EO) to the patient name, treatment allocation, time-point and archwire group during study model analysis. The models were rematched to the patient and archwire group after data collection was complete.

Assignment and treatment intervention

Patients were randomized to one of three archwire sequence groups. A restricted randomization process

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Outcome measures
The primary outcome investigated was the time required to reach the working archwire. This was determined from the patient records and expressed in months. Secondary outcomes included the discomfort experienced at each archwire change and total discomfort for each archwire sequence. In addition, Littles10 irregularity index score after removal of the rst and second archwire was determined, as well as the mandibular intercanine width after removal of the rst and second archwires. Discomfort levels were recorded using questionnaires completed by the patients using a seven-point Likert scale from 05no pain to 75worst pain, at 4 h, 24 h, 3 days and 1 week after each archwire change.11,12 The mean discomfort scores were calculated for each archwire sequence using the same technique as Mandall et al.7 For example, the score at 4 h for the 3M Unitek archwire sequence was calculated by averaging the discomfort scores for the rst, second and third archwire in the sequence at 4 h. Littles10 irregularity index was measured to quantify the degree of tooth alignment of the six anterior mandibular teeth. The study models were measured with electronic callipers (Mitutoyo Corporation, Tokyo, Japan) that were accurate to 0.01 mm. Intercanine widths were measured from the cusp tips of the canines. Measurements were performed by a single researcher and intra-examiner reliability was determined by remeasuring 25 cases at least 4 weeks after the original measurements were taken. The pre-treatment lower anterior crowding was also assessed to determine pre-treatment equivalence between the three groups. This was calculated as the difference between the arch space required and space available. The arch space required was calculated by summing the mesiodistal widths of the incisors and canines. The space available was calculated by summing the distance from the distal contact point of the canine to the mesial contact point of the central incisor on both sides of the arch.11,12

sample size was increased to 132 (44 patients per treatment group) to allow for a dropout rate of up to 10%. Intra-examiner error was assessed using paired t tests for systematic error and by examining Bland and Altman plots13 for random error. Descriptive statistics were calculated and the archwire groups were compared for pre-treatment characteristics including age at the start of treatment, gender, mandibular anterior crowding, intercanine width and Littles10 irregularity index. The data were checked for normality. Analysis of the pre-treatment variables did not indicate an association with the outcome variables; therefore, a one-way analysis of variance general linear model (ANOVAGLM) with Tukey correction was used to compare the archwire groups. A KruskalWallis non-parametric test was used when the data were not normally distributed for a particular time-point. The independent variable was archwire group. Statistical analysis was performed using Minitab Release 15 (Minitab Incorporated, State College, PA, USA). A signicance level of P,0.05 was used for all tests.

Results
One hundred and forty-two consecutive patients were assessed for eligibility to enter the study and 132 were recruited. The pre-treatment characteristics for the three groups are summarized in Table 1. There were 80 females and 52 males, with a mean age of 15.4 year (SD 6.6 years). Figure 1 is a diagram showing the ow of patients through the study. One patient transferred and was lost to follow up; therefore, 131 patients completed the trial. Some of the irregularity data were lost because nine study models were missing and two were broken. Some discomfort data were also lost because 63 questionnaires were not returned. The data were checked for
Table 1

Pre-treatment characteristics of the archwire groups. 3M Unitek GAC 15.5 (6.4) 19 : 25 7.8 (4.9) 3.7 (2.7) Ormco 16.1 (8.3) 19 : 25 5.8 (3.5) 2.8 (2.4)

Statistics
A priori sample size calculation was undertaken using data from a previous study.7 A clinically signicant difference of 3 months to reach the working archwire was chosen, with a standard deviation of 4 months. It was determined that 120 patients (40 patients per treatment group) were required to detect a clinically signicant difference between the sequences with a power of 0.99 to a signicance level of P,0.05. The

Age at start, mean in years (SD) Male/female ratio Irregularity, mean (SD) in mm Lower anterior crowding, mean (SD) in mm Intercanine width, mean (SD) in mm

14.4 (4.4) 14 : 30 6.6 (5.0) 3.6 (2.8)

25.3 (1.7)

25.2 (2.4)

25.9 (2.3)

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Figure 1 CONSORT diagram for time to working archwire and irregularity data

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The general time-course of the discomfort experience is illustrated in Figure 3. All archwires induced discomfort at 4 h. The discomfort levels peaked at 24 h then subsided to almost baseline levels by 7 days. Mean irregularity scores decreased over time in all three archwire groups (Table 4). There were no statistically signicant differences between the groups at any time-point. Intercanine widths increased in all archwire groups and there was no evidence of a statistically signicant difference between the groups (P50.09). Figure 4 illustrates the archforms of the archwires from each manufacturer. There were no signicant differences in the mean discomfort scores between the genders at any of the time-points (Figure 2) (4 h: P50.76; 24 h: P50.52; 3 days: P50.08; 7 days: P50.07; ANOVA-GLM).
Figure 2 Line plot of mean discomfort in males and females

non-response bias and there were no signicant differences in the number of returned forms between the archwire groups, therefore, this is unlikely to have affected the results (ANOVA-GLM; T1: P50.93; T2: P50.99; T3: P50.95). Intra-examiner reliability was good. The mean differences between the rst and second measurements were 0.18 mm (SD 0.56) for the irregularity index and 0.07 mm (SD 0.36) for intercanine width. There was no evidence of systematic error (irregularity index, P50.13; intercanine width, P50.33) and examination of the Bland and Altman,3 scatterplots1 showed low random error. The mean times taken to reach the working archwire for the three groups are shown in Table 2. There was no statistically signicant difference between the groups (ANOVA; P50.29). The mean discomfort scores at 4 h, 24 h, 3 days and 7 days for the three groups are given in Table 3 and shown graphically in Figure 2. There were no statistically signicant differences between the scores for the archwire sequence groups at any of the time-points. The time-points were also compared individually. Following the insertion of the third archwire (T3), the Ormco and GAC archwires induced signicantly greater discomfort than the 3M Unitek archwire at 24 h (3M Unitek: 2.9; GAC: 3.4; Ormco: 3.4; ANOVA-GLM; P50.02).
Table 2

Discussion
This study demonstrated that the archwire sequences investigated were not signicantly different in terms of alignment efciency, overall discomfort experience and the time required to reach the working archwire. These results are in general agreement with Mandall et al.s7 ndings who investigated three Ormco archwire sequences in 0.02260.028-inch brackets. This is the rst in vivo study to compare archwire sequences from different manufacturers. In vitro studies have shown that the mechanical properties of NiTi archwires vary signicantly between manufacturers.14,15 This study suggests that the in vitro differences are insignicant in a clinical scenario. The archwire sequences in this study were not signicantly different in terms of the time taken to reach the working archwire. Interestingly, the mean times in this trial were 24 months shorter than Mandall et al.s7 despite the patients in both trials starting with similar pretreatment labial segment crowding and irregularity index scores. One possible explanation for this may be that the clinician in this study placed the succeeding NiTi archwire as soon as complete engagement was possible, even if the previous archwire was not entirely passive. Therefore, the second archwire may have been placed sooner than in Mandall et al.s study which allowed faster

Time taken to reach working archwire (months) and P value (ANOVA). 3M Unitek GAC n544 4.4 (1.2) Ormco n542 4.0 (1.2)* P 0.29

Variable Time to working archwire, mean (SD)

n544 4.0 (1.2)

*This calculation is based on 42 observations because one patient transferred and one patients data were missing.

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Figure 3 Line plot of mean discomfort scores over time

progression to the working archwire. Additionally, the decreased play with 0.01860.025-inch brackets in this study may have contributed to increased levelling and alignment efciency compared to 0.02260.028-inch brackets used in Mandall et al.s7 study. Previous studies have only compared initial aligning archwires, which corresponds to the T1 to T2 time period in this study. This study found no evidence of a difference in efciency between archwires of 0.014 inch diameter when one non-superelastic (3M Unitek) archwire was compared with two superelastic, heat activated archwires (Damon and GAC) in the mandibular arch. Two previous randomized clinical trials did not nd any clinical advantage when they compared 0.016 inch superelastic NiTi and conventional NiTi archwire in the maxillary arch.3,16 Pandis et al.16 concluded that clinical factors such as the loading pattern of the archwires may effectively eliminate the advantages of superelastic NiTi observed in the laboratory. The present study found no evidence of signicant differences in the overall discomfort levels between archwire sequences. However, when the time-points
Table 3 Mean (SD) overall (average of T1, T2 and T3) discomfort scores and P value (ANOVA).

Figure 4 Comparison of 3M, GAC and Ormco archforms. 1: 3M Orthoform II archform; 2: GAC Medium Ideal archform; 3: Ormco Damon archform

were analysed individually, the 3M Unitek archwire sequence induced signicantly less discomfort than the GAC and Ormco sequences 24 h after the insertion of the third archwire. Interestingly, the third archwire, 0.01660.022 inch stainless steel, was the same dimension and material in all three groups. It is easy to assume that the difference in discomfort arose from the progression in archwire dimension. However, this may be an over-simplication. Although the 3M Unitek archwire sequence had the smallest increase in dimension inciso-gingivally from the second to third archwire, it also had the greatest increase labio-lingually. Furthermore, the sequences induced comparable discomfort levels at T2, despite various increases in dimensions from the rst to the second archwires. There may have been other factors such as the progression in archwire material and archform that contributed to discomfort.
Table 4 Mean (SD) irregularity scores at T1, T2 and T3 (in mm) and P value (ANOVA).

3M Unitek Time-point n541,41,41 6.6 (5.0) 2.2 (0.9) 2.0 (0.7)

GAC n543,43,43 7.8 (4.9) 3.0 (2.8) 2.1 (1.1)

ORMCO n544,43,42 5.8 (3.5) 2.1 (0.9)* 2.0 (0.7){ P value 0.12 0.21{ 0.78

3M Unitek Variable 4h 24 h 3 days 7 days n523 2.4 2.8 1.7 1.2 (1.0) (1.1) (0.8)* (0.3)*

GAC n520 2.7 3.3 2.0 1.3 (0.8) (1.1) (0.8) (0.6)

Ormco n520 2.9 3.2 1.8 1.1 (1.2) (0.8) (0.9) (0.2) P 0.31 0.17 0.53 0.49

T1 T2 T3

*This calculation is based on 22 observations.

*This calculation is based on 43 observations because one patients model was missing or broken. {This calculation is based on 42 observations because one patients model was missing or broken. {KruskalWallis non-parametric test.

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The general time-course of pain following archwire insertion in this study concurs with previous reports of orthodontic pain.9,11,12,1719 The discomfort levels climaxed at 24 h after archwire placement, then gradually declined to almost baseline levels by day 7. In general, the levels of reported discomfort were low and similar to the mean levels of discomfort reported by Mandall et al.7 Interestingly, despite faster progression, the peak discomfort scores at 24 h in this study were less than those reported in Mandall et al.s7 study. In vitro studies have demonstrated that superelastic archwires are able to deliver constant, light force levels.2023 It has been suggested that lighter forces can optimize tooth movement and generate less pain.2427 However, the relationship between force levels and pain remains unclear.17 From T1 to T2, this study compared Nitinol (non-superelastic NiTi) with two superelastic, heat activated NiTi archwires. This study demonstrated that Nitinol did not induce more pain than superelastic NiTi. This disagrees with the ndings of Fernandes et al.19 who compared 0.014 inch Sentalloy with 0.014 inch Nitinol and found Nitinol induced signicantly higher levels of pain than Sentalloy at 4 h. In agreement with previous studies11,19,28,29, there were no statistically signicant differences in discomfort scores between males and females. The evidence regarding a relationship with age remains equivocal. Two previous studies suggested that patients younger than 16 years,30 or 13 years31 experience less pain. Conversely, the results of this study concur with Scott et al.32 who did not nd an association between age and discomfort. Theoretically, increased crowding can induce higher force levels and therefore increase pain. However, several investigations including this one have not been able to demonstrate an association between crowding and discomfort.17,30 One of the major strengths of this study was the randomization process to offset potential confounding factors. Variation in clinical factors such as reduced inter-appointment intervals, or various ligation techniques was unlikely to have introduced bias because randomization allowed these factors to be equally distributed across the archwire groups. There are a number of limitations to this study. Firstly the clinician who adjusted the appliance is a solo practitioner and was not masked to the archwire group. Secondly, missing data decreased the power of the irregularity index and discomfort analysis. The primary outcome was the time to aligning the teeth and therefore the sample size was based on this rather than the other outcomes. Therefore, there may not have been sufcient power to detect a signicant difference between the other outcomes. However, the results of this study

suggest that the power of this sample is acceptable because the differences between the means of the nonsignicant results were not clinically meaningful. For example, the greatest magnitude of difference in irregularity index was 0.9 mm at T2, and 0.5 in discomfort when considered overall and when comparing male versus female groups. Thirdly, this study only evaluated archwire sequences in 0.018 inch slot brackets. However, both 0.018 inch and 0.022 inch slot sizes are commonly used in modern orthodontics. Keim et al.33 reported that 40.5% of orthodontists used 0.018 inch slot size. Future research for 0.022 inch slot brackets may be benecial.

Conclusions

N N

No differences were found between the archwire sequences in the time taken to reach the working wire or reduction in irregularity index. No differences were found between the archwire sequences in overall discomfort. Progression in archwire dimension and archform may contribute to discomfort levels. There was no evidence that the level of discomfort induced was associated with initial crowding, gender or age.

Contributors
Emily Ong was responsible for gaining ethical approval, data collection, data analysis, writing and revising the report. Christopher Ho was responsible for gaining ethical approval, data analysis, data interpretation, as well as critical revisions and nal approval of the report. Peter Miles was responsible for study design, gaining ethical approval, recruitment of patients, data collection, data analysis, writing and revising the report. Peter Miles is the guarantor.

Acknowledgements
This study was supported by a grant from the Australian Society of Orthodontists Foundation for Research and Education.

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