Active or passive self-ligating brackets? A randomized controlled trial of comparative efficiency in resolving maxillary anterior crowding in adolescents



Active or passive self-ligating brackets? A randomized controlled trial of comparative efficiency in resolving maxillary anterior crowding in adolescents




American Journal of Orthodontics and Dentofacial Orthopedics, 2010-01-01, Volume 137, Issue 1, Pages 12.e1-12.e6, Copyright © 2010 American Association of Orthodontists


Introduction

Our aim was to compare the time required to complete the alignment of crowded maxillary anterior teeth (canine to canine) between Damon MX (Ormco, Glendora, Calif) and In-Ovation R (GAC, Central Islip, NY) self-ligating brackets.

Methods

Seventy patients from the first author's office were included in this randomized controlled trial by using the following inclusion criteria: nonextraction treatment on both arches, eruption of all maxillary teeth, no spaces in the maxillary arch, no high canines, maxillary irregularity index greater than 4 mm, and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgear. The patients were randomized into 2 groups: the first received a Damon MX bracket; the second was bonded with an In-Ovation R appliance, both with a 0.022-in slot. The amount of crowding of the maxillary anterior dentition was assessed by using the irregularity index. The number of days required to completely alleviate the maxillary anterior crowding in the 2 groups was investigated with statistical methods for survival analysis, and alignment rate ratios for appliance type and crowding level were calculated with the Cox proportional hazard regression. An analysis of each protocol was performed.

Results

No difference in crowding alleviation was found between the 2 bracket systems. Higher irregularity index values were associated with the increased probability of delayed resolving of crowding.

Conclusions

The use of passive or active self-ligating brackets does not seem to affect treatment duration for alleviating initial crowding.

The last decade has witnessed unprecedented progress in the development of new appliances with alternative ligating features. Passive and active self-ligating appliances with many ligating mechanisms were introduced to presumably allow for efficient sliding mechanics. This feature was linked with several presumed effects including lower forces and moments and higher rates of tooth movement, because of the reduced friction and absence of binding of ligatures on wire. Nonetheless, for most of these appliances, there is little evidence about the characteristics and capabilities claimed by the manufacturers, and, in some cases, it seems that marketing-derived principles rather than scientific evidence is used to substantiate their well-advertised clinical performance. Thus, the resultant turmoil in this specialty has no support in the literature, since most published trials do not show superior efficiency of self-ligating brackets regardless of type or ligating mechanism.

The available evidence on the efficiency of self-ligating brackets derives from a few prospective and randomized clinical trials, with most prospective and randomized controlled trials (RCTs) demonstrating no difference in treatment duration between conventional and self-ligating brackets.

Recently, the relatively low validity and reliability of retrospective studies as opposed to prospective and especially RCTs have switched investigators' interests to the latter type of studies. RCTs are preferred because of the elimination of selection and outcome biases of retrospective studies. Currently, there is little evidence from this type of study on the potential differences between passive and active self-ligating brackets in tooth movement rates.

The purpose of this study was to compare the time required to complete the alignment of crowded maxillary anterior teeth (canine to canine) between passive and active self-ligating brackets.


Material and methods

Seventy patients were included in this RCT, selected from a large pool of patients from the first author's office. The following inclusion criteria were used: nonextraction treatment in both arches, eruption of all maxillary teeth, no spaces in the maxillary arch, no high canines, maxillary irregularity index greater than 4 mm, and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgear. The patients were selected and treated between March 2007 and May 2009. Their demographics are shown in Table I .

Table I
Demographic and clinical characteristics of sample
Total (n = 70) mean or % SD Damon MX (n = 35) mean or % SD In-Ovation R (n = 35) mean or % SD P value
Demographic characteristics
Age (y) 13.8 1.8 13.8 1.8 13.8 1.7 NS
Sex (%)
Girls 58.6 60.0 57.0 NS
Boys 41.4 40.0 43.0
Clinical characteristics
Crowding (irregularity index, mm) 7.5 2.1 8.0 2.1 7.0 2.0 NS
Angle class (%)
I 48.6 51.4 45.7 NS
II 47.1 42.9 51.4
III 4.3 5.7 2.9
NS, Not significant.

P value for comparison of group means by t test or differences in proportions by chi-square test and Fisher exact test.

The active self-ligating group was bonded with the Roth prescription In-Ovation R bracket (GAC, Central Islip, NY), and the passive self-ligating group received the high-torque version of the Damon MX (Ormco, Glendora, Calif), both with a 0.022-in slot. All first and second (when present) molars were bonded with Speed bondable tubes (Speed System Orthodontics, Cambridge, Ontario, Canada). Bracket bonding, archwire placement, and treatment were performed by the first author.

The amount of crowding of the maxillary anterior dentition was assessed by using the irregularity index described by Little. Measurements were made twice on the initial casts by the first author with a digital caliper (Digimatic NTD12-6”C, Mitutoyo, Tokyo, Japan).

Archwire sequence was the same for both treatment groups: 0.014-in Damon arch form copper-nickel-titanium 35°C (Ormco), followed by a 0.016 × 0.025-in Damon arch form copper-nickel-titanium 35°C (Ormco).

Seventy patients (mean age, 13.8 years) were randomized to either an active or a passive self-ligating appliance. Randomization was accomplished by generating random permuted blocks of variable size; this ensured equal patient distribution between the 2 trial arms. Numbered, opaque, sealed envelopes were prepared before the trial containing the treatment allocation card. After patient selection, the secretary of the practice was responsible for opening the next envelope in sequence.

Based on previous research, it was assumed that a hazard ratio larger than 2 between the bracket groups would be an important clinical finding. Sample size was calculated. Based on this assumption, the required sample size was calculated at 66 (a = 0.05, power = 80%), and it was decided to include 70 subjects in case of any losses.

The date (T1) that each patient was bonded was recorded. All patients were followed monthly. Complete alleviation of crowding was judged clinically by the first author. On visual inspection of correction of proximal contacts, the patient was considered complete, and the alignment date (T2) was determined and recorded on the spreadsheet. Only the alignment of the 6 maxillary anterior teeth was evaluated. In other words, we considered that a patient had reached the T2 stage if the 6 maxillary anterior teeth were aligned, regardless of possible irregularities in posterior segments. The time to alignment (T2 – T1) for each patient was calculated in days. Blinding of outcome assessment was not feasible for this study. To assess the reliability of the method, the irregularity index was remeasured a month later in 20 models, selected randomly, and good agreement was found between the first and the second measurement (ICC >0.95).


Statistical analysis

Demographic and clinical characteristics were investigated with conventional descriptive statistics. Comparisons of these between the 2 appliance groups were conducted with t tests or chi-square tests, depending on the characteristic (parametric or nonparametric). Treatment duration—the time required to resolve crowding in both appliance groups—was investigated with statistical methods for survival analysis; alignment rate ratios for appliance type and crowding level were calculated with the Cox proportional-hazards regression. A 2-tailed P value of 0.05 was considered statistically significant with a 95% confidence interval.


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Active or passive self-ligating brackets? A randomized controlled trial of comparative efficiency in resolving maxillary anterior crowding in adolescents Nikolaos Pandis , Argy Polychronopoulou and Theodore Eliades American Journal of Orthodontics and Dentofacial Orthopedics, 2010-01-01, Volume 137, Issue 1, Pages 12.e1-12.e6, Copyright © 2010 American Association of Orthodontists Introduction Our aim was to compare the time required to complete the alignment of crowded maxillary anterior teeth (canine to canine) between Damon MX (Ormco, Glendora, Calif) and In-Ovation R (GAC, Central Islip, NY) self-ligating brackets. Methods Seventy patients from the first author's office were included in this randomized controlled trial by using the following inclusion criteria: nonextraction treatment on both arches, eruption of all maxillary teeth, no spaces in the maxillary arch, no high canines, maxillary irregularity index greater than 4 mm, and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgear. The patients were randomized into 2 groups: the first received a Damon MX bracket; the second was bonded with an In-Ovation R appliance, both with a 0.022-in slot. The amount of crowding of the maxillary anterior dentition was assessed by using the irregularity index. The number of days required to completely alleviate the maxillary anterior crowding in the 2 groups was investigated with statistical methods for survival analysis, and alignment rate ratios for appliance type and crowding level were calculated with the Cox proportional hazard regression. An analysis of each protocol was performed. Results No difference in crowding alleviation was found between the 2 bracket systems. Higher irregularity index values were associated with the increased probability of delayed resolving of crowding. Conclusions The use of passive or active self-ligating brackets does not seem to affect treatment duration for alleviating initial crowding. The last decade has witnessed unprecedented progress in the development of new appliances with alternative ligating features. Passive and active self-ligating appliances with many ligating mechanisms were introduced to presumably allow for efficient sliding mechanics. This feature was linked with several presumed effects including lower forces and moments and higher rates of tooth movement, because of the reduced friction and absence of binding of ligatures on wire. Nonetheless, for most of these appliances, there is little evidence about the characteristics and capabilities claimed by the manufacturers, and, in some cases, it seems that marketing-derived principles rather than scientific evidence is used to substantiate their well-advertised clinical performance. Thus, the resultant turmoil in this specialty has no support in the literature, since most published trials do not show superior efficiency of self-ligating brackets regardless of type or ligating mechanism. The available evidence on the efficiency of self-ligating brackets derives from a few prospective and randomized clinical trials, with most prospective and randomized controlled trials (RCTs) demonstrating no difference in treatment duration between conventional and self-ligating brackets. Recently, the relatively low validity and reliability of retrospective studies as opposed to prospective and especially RCTs have switched investigators' interests to the latter type of studies. RCTs are preferred because of the elimination of selection and outcome biases of retrospective studies. Currently, there is little evidence from this type of study on the potential differences between passive and active self-ligating brackets in tooth movement rates. The purpose of this study was to compare the time required to complete the alignment of crowded maxillary anterior teeth (canine to canine) between passive and active self-ligating brackets. Material and methods Seventy patients were included in this RCT, selected from a large pool of patients from the first author's office. The following inclusion criteria were used: nonextraction treatment in both arches, eruption of all maxillary teeth, no spaces in the maxillary arch, no high canines, maxillary irregularity index greater than 4 mm, and no therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, maxillary expansion appliances, or headgear. The patients were selected and treated between March 2007 and May 2009. Their demographics are shown in Table I . Table I Demographic and clinical characteristics of sample Total (n = 70) mean or % SD Damon MX (n = 35) mean or % SD In-Ovation R (n = 35) mean or % SD P value ∗ Demographic characteristics Age (y) 13.8 1.8 13.8 1.8 13.8 1.7 NS Sex (%) Girls 58.6 60.0 57.0 NS Boys 41.4 40.0 43.0 Clinical characteristics Crowding (irregularity index, mm) 7.5 2.1 8.0 2.1 7.0 2.0 NS Angle class (%) I 48.6 51.4 45.7 NS II 47.1 42.9 51.4 III 4.3 5.7 2.9 NS, Not significant. ∗ P value for comparison of group means by t test or differences in proportions by chi-square test and Fisher exact test. The active self-ligating group was bonded with the Roth prescription In-Ovation R bracket (GAC, Central Islip, NY), and the passive self-ligating group received the high-torque version of the Damon MX (Ormco, Glendora, Calif), both with a 0.022-in slot. All first and second (when present) molars were bonded with Speed bondable tubes (Speed System Orthodontics, Cambridge, Ontario, Canada). Bracket bonding, archwire placement, and treatment were performed by the first author. The amount of crowding of the maxillary anterior dentition was assessed by using the irregularity index described by Little. Measurements were made twice on the initial casts by the first author with a digital caliper (Digimatic NTD12-6”C, Mitutoyo, Tokyo, Japan). Archwire sequence was the same for both treatment groups: 0.014-in Damon arch form copper-nickel-titanium 35°C (Ormco), followed by a 0.016 × 0.025-in Damon arch form copper-nickel-titanium 35°C (Ormco). Seventy patients (mean age, 13.8 years) were randomized to either an active or a passive self-ligating appliance. Randomization was accomplished by generating random permuted blocks of variable size; this ensured equal patient distribution between the 2 trial arms. Numbered, opaque, sealed envelopes were prepared before the trial containing the treatment allocation card. After patient selection, the secretary of the practice was responsible for opening the next envelope in sequence. Based on previous research, it was assumed that a hazard ratio larger than 2 between the bracket groups would be an important clinical finding. Sample size was calculated. Based on this assumption, the required sample size was calculated at 66 (a = 0.05, power = 80%), and it was decided to include 70 subjects in case of any losses. The date (T1) that each patient was bonded was recorded. All patients were followed monthly. Complete alleviation of crowding was judged clinically by the first author. On visual inspection of correction of proximal contacts, the patient was considered complete, and the alignment date (T2) was determined and recorded on the spreadsheet. Only the alignment of the 6 maxillary anterior teeth was evaluated. In other words, we considered that a patient had reached the T2 stage if the 6 maxillary anterior teeth were aligned, regardless of possible irregularities in posterior segments. The time to alignment (T2 – T1) for each patient was calculated in days. Blinding of outcome assessment was not feasible for this study. To assess the reliability of the method, the irregularity index was remeasured a month later in 20 models, selected randomly, and good agreement was found between the first and the second measurement (ICC >0.95). Statistical analysis Demographic and clinical characteristics were investigated with conventional descriptive statistics. Comparisons of these between the 2 appliance groups were conducted with t tests or chi-square tests, depending on the characteristic (parametric or nonparametric). Treatment duration—the time required to resolve crowding in both appliance groups—was investigated with statistical methods for survival analysis; alignment rate ratios for appliance type and crowding level were calculated with the Cox proportional-hazards regression. A 2-tailed P value of 0.05 was considered statistically significant with a 95% confidence interval. Results Figure 1 is the CONSORT flowchart. Table I shows the distribution of demographic variables of the groups including age, sex, irregularity index, and Angle classification. There was no discrimination with respect to these factors between the 2 groups, validating the random assignment of appliances to each group. Four patients were excluded from the statistical analysis because of poor compliance, and the statistical analysis was conducted per protocol, since loss to follow-up was not associated with type of treatment. Fig 1 CONSORT flowchart of the study. In Table II , the results of the treatment time to alignment are shown for the 2 bracket groups; no statistical significance was found. Table II Treatment time to alignment by wire system and crowding severity Total Mean time to alignment (d) Minimum (d) Median (d) Maximum (d) P value ∗ Wire system Damon MX 33 107.1 56 99 175 NS In-Ovation R 33 95.0 54 92 161 Total 66 101.0 54 95.5 175 NS, Not significant. ∗ P value based on the log-rank test for equality of survivor functions. The results of the Cox proportional-hazards model are given in Table III . The In-Ovation R appliance had a 1.4 hazard ratio over the Damon MX bracket; this implied that the former had a 1.4 times higher probability of alleviating crowding earlier than the latter, but this effect did not reach statistical significance. On the contrary, higher irregularity index values were associated with increased probability of delayed resolving of crowding ( P <0.05). Table III Alignment rate ratios derived from the Cox proportional-hazards regression Predictor Adjusted hazard ratio ∗ 95% CI P value Bracket system Damon MX Baseline In-Ovation R 1.46 0.85-2.51 NS Crowding Irregularity index (mm) 0.73 0.64-0.84 <0.05 NS, Not significant. ∗ Hazard ratios adjusted for demographic characteristics and Angle class. Figure 2 depicts the Kaplan-Meier survival curves for the 2 bracket groups; lack of separation implies no statistically significant difference. Fig 2 Kaplan-Meier survival curves for the 2 appliances used in the study, indicating lack of separation; this implies no significant effect on treatment duration. Discussion The results of this study emphasize the clinical irrelevance of the typical in-vitro assessment of friction protocols in many studies during the past decade. A number of factors related to the oversimplicity of experimental configurations and the overwhelming number of assumptions in the experimental design have deprived ex-vivo friction assessment of clinical relevance and scientific soundness. These briefly include the rate of wire sliding onto slot walls, application of forces on wire, lack of intraoral aging of materials, and study of variables with little or no relevance to the actual clinical situation. A recent critical review of this topic clarified several misconceptions of the study of static and kinetic friction and their clinical applicability, suggesting that the importance of this parameter has been overestimated in relevant research. Small differences in the torque prescriptions between the 2 brackets were not expected to influence the outcome because these were outweighed by the large free play that was more than 2 times higher than the torque differences in a conventional bracket. Registration of the irregularity index changes in this study was performed at the end of treatment because the rate of correction was unknown; therefore, changes registered at a certain time during therapy might not hold for the entire treatment. The use of monthly monitoring intervals was not a bias because this method was applied to both bracket groups. The results of this RCT with the body of evidence on this issue suggest that the bracket-archwire free play might not be the most critical factor in altering the tooth movement rate. The large clearance in self-ligating over conventional brackets and the presumed lower binding of Damon MX relative to the In-Ovation R appliance might be eliminated as archwires of larger cross sections are gradually placed in the bracket slot. The clinician might empirically appreciate the free play with self-ligating brackets, especially in patients with extreme tooth malalignment, when complete engagement of certain diameters of nickel-titanium wire might not be feasible with conventional brackets. This situation, however, changes drastically as treatment progresses and wires of higher stiffness are engaged in the bracket. Correction of rotations and achievement of proper buccolingual crown inclination (torque), which are frequently required in mandibular and maxillary anterior teeth, respectively, necessitate a couple of forces. This assumes the formation of contacts of wire inside the bracket slot walls, and thus the major advantage of self-ligating brackets—free play—is eliminated as the crowns gradually attain their proper spatial orientation. Especially for torque application, self-ligating brackets lose more torque compared with conventional brackets, whereas a clinical trial showed that these brackets can achieve comparable torque transmission only with reverse curve of Spee archwires. Alternatively, torquing auxiliaries, higher torque prescription brackets, or pretorqued wires can be used to counteract the greater torque loss from greater free play. These results agree with several studies that found no difference in treatment duration in canine retraction and crowding alleviation between conventional and various self-ligating brackets. Regardless of the type of movement and ligation mechanism of self-ligating brackets, the results of these trials are consistent with a lack of treatment duration differences. For the active self-ligating bracket, the clip should theoretically prevent this by applying a force on the wire; however, the relaxation of clip for the In-Ovation R bracket reported previously contributes to the lack of consistent engagement of the wire throughout treatment. Conclusions The results of this RCT suggest that active and passive self-ligating brackets have no difference in treatment duration in the correction of maxillary anterior crowding, in contrast to the extent of crowding, which had an effect on the duration of treatment. The authors report no commercial, financial, or proprietary interest in the products or companies described in this article. References 1. Harradine N.W.: Self-ligating brackets and treatment efficiency. Clin Orthod Res 2001; 4: pp. 220-227 2. Harradine N.W.: Self-ligating brackets: where are we now? J Orthod 2003; 30: pp. 262-273 3. Shivapuja P.K., and Berger J.: A comparative study of conventional ligation and self-ligation bracket systems. 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