Cephalometric evaluations A cephalometric evaluation of the dental and facial-skeletal effects using the Bionator with stepwise protrusive activations Sandéep Kumar / SS, Sidhu** / OP. Kharbanda*** A study was conducted to ascertain dental effects of step-wise mandibular advancement with Bionator therapy. A sample of 24 girls in the age group of 9 10 12 years having Class Il, Division ] malocclusion was well matched for age, severity of malocclusion and craniofacial morphology. The sample was divided into three groups. Eight girls underwent step-wise ‘mandibular advancement in three stages, while eight were treated with single step advancement, Eight girls acted as control who did not undergo any treatment. The total treatmenvobservation period was 9 months. The cephalometric analysis revealed that the progressive mandibular advancement enhances favorable facio-skeletal changes, more so in the mandible. The sagittal correction was predominantly of skeletal type with step-wise advancement, while with single step advancement it was due to both skeletal and dental changes. J Clin Pediatr Dent 20(2):101-108, 1996 INTRODUCTION lorrection of distocclusion with the use of func- tional appliances has become a popular method ‘of treatment among orthodontists. Functional appliances help to achieve a normal sagittal relation- ship by favorably altering the aberrant growth pattern of the mandible, ‘The most critical step in the construction of a fune- tional appliance is the recording of the construction bite. The sagittal displacement of the mandible achieved with a functional appliance invariably is asso- ciated with concomitant vertical displacement: howev- er, the predominance of either sagittal or vertical acti- vation builtin to appliance can influence the treatment response. Although several investigations have been reported on the effects of increasing amounts of vertical open- "Sandeep Kumar MDS. Former Postgraduate Student, Department Of Denial Surgery, All India Insitute of Medici Sciences, New Delhi, Inia. “+ SS, Sidhu BDS. MDS. DFR, FICD, FAMS. Former Professor of Orthodontics and Mead. Department of Dental Surgery. All ‘aka Insitute OF Medical Seiences New Delhi 110029 india "OF. Kharbanda BOS. MDS. Associate Professor of Orthodontics Department of Dental Surgery Al Init Instate ‘of Medical Sceness. New Delhi 110029 Ina Address all correspondence to: Dr. O.P. Kharbnds, Associate Professor. Division of Onthodonties Depurtment of Dental Surgery All India Institute of Medieal Selenees. New Delft 110029 laa, ‘Telephone » Office 6 123-323-2755, O864851-3231-2785, Fax: Vi -685-2665, Telephone Residence 6556, ing in the orofacial region, litle attention has been given to systematic evaluation of the effects of vatied amounts of sagittal activation, Investigations by Witt and Kamposch’ have shown that in patients with mandibular retrusion when the mandible is displaced anteriorly by a millimeter. the forces of stretched retractors are approximately 100 grams. ‘Therefore, when initial construction bite is taken ‘with mandible displaced forward by 6 to 7 mm. consid- erable forces are transmitted to the dentition. This inevitably results in largely tooth-moving effects. The protractor muscles are incapable of holding the mandible in such an extremely advanced position. AS a result the mandible drops inferiorly and slides back- ward. Other investigators have expressed concern that potential temporomandibular joint disturbances. may be caused by functional appliances with single mandibular advancement. The results of experimental studies by Stockli and Willert.’ Petrovic and Stutamann and others have suggested that a favorable and continuing response of condylar tissue may result from gradual mandibular advancement. DeVincenzo and Winn’ studied the effect of differing amounts of protrusive activation built into a functional appliance that was worn full time. ‘They evaluated 50 patients with Class Il, Division | malocclusion, treated with I mm and 3 mm progressive activation and single large activation. Tae results showed that in the 3 mm progressive-activation group, the increase in the SNB angie was maximum, and alsoVepnaiumeuic evaiuations: the potential to limit anterior vertical development was better. ‘Op Heij and co-workers evaluated the treatment effects of a variable degree of forward posturing of mandible with the Bionator. They also concluded that the nature and magnitude of treatment effects brought about by the Bionator differed significantly when the amount of protrusion built into the Bionator was changed, Remmelink and Tan’ used a headgear-activator combination capable of providing progressive forward posturing of mandible. Their results also showed bet- ter correction of sagittal jaw relationship and control of the vertical dimension with this appliance. The find- ings of clinical investigation by Falck and Franke? sug- gested that a tooth-moving effect was observed in both jaws when the mandible was advanced at one time by 5 to 6 mm, whereas the sagittal discrepancy between the maxilla and mandible remained unchanged. In contrast, a step-by-step mandibular advancement resulted in a significant improvement in sagittal jaw relationship with only slight tooth movements. In view of the limited literature available on the subject, this controversy still exists. ‘A study was undertaken to find out whether single- step advancement or step-by-step advancement under- taken in Bionator therapy will produce more favorable response. The aims and objectives of the study werg: 1, To evaluate cephalometrically dental and facio- skeletal changes resulting from the use of the Bionator with step-wise protrusive activation. 2. To compare these effects with those produced by the Bionator with a single large activation. MATERIALS AND METHODS The study was conducted on a sample of 24 girls, having Class IT, Division 1 malocclusion, in the age group of 9 to 12 years, taken among the patients attending the Orthodontics Clinic (Table 1). Each subject conformed to the following criteria for ‘with inclusion in the study: Angle’s Class Il, Division 1 malocclusion with normal maxilla and retruded mandible, an overjet of more than 6 mm, a complete set of teeth for that particular age, well aligned upper and lower dental arches with minimal crowding or rotations, an absence of severe labial tipping of the lower incisors and no history of any previous orthodontic treatment ‘The sample was divided into three groups of eight patients each. Group I was comprised of patients ireated with a Bionator using step-wise protrusive acti- vation: Group If was comprised of patients treated with a Bionator using single large protrusive activation to an edge-to-edge bite, Group III acted as control. i.e., patients in this group did not undergo any orthodontic treatment dur- ing observation period of nine months. They subse- ‘quently were treated with suitable fixed appliances. The treatment period for the study was nine months. The present study enlarges an earlier work done in the department on the Bionator (Fig. |) using. single-step mandibular advancement. It was observed that after a period of approximately six months, there was sufficient improvement in facial and dental devel- opment, with the establishment of normal overjet and overbite relationships. Further. stabilization of the results was achieved in another three or four months. Hence, a period of nine months was taken as the observation period for the purpose of this study. Further follow-up of these cases is in progress. ‘The subjects of Group 1 underwent an initial pro- trusive activation of 3 mm. This activation was fol- lowed by second and third progressive reactivation of the mandible at the third and sixth month of the study. The construction bite of subjects in Group [I was, recorded in an edge-to-edge incisal position at the start of the treatment, and no further advancement was made during the subsequent nine months. ‘The subjects under treatment were constructed to wear the appliances at all times except during meals, ‘The patients were called for follow-up every two to three weeks and were examined clinically for adapt- ability and chewing difficulties. To allow eruption of lower posterior teeth, acrylic relief was provided in a sequential manner over the desired teeth. Diagnostic casts, lateral cephalograms, and intra and extra oral photographs were taken at the start and. at termination of active treatment, ic., at the end of nine months. Lateral cephalograms were taken using a standardized method before the start of treatment in Table 1: Age and treatment/observation time of three groups. “Stepwise Blonator Single Step Blonator Gonivel Group S.No. Variable ‘Therapy (Group I) ‘Thorapy (Group I) Group Significance Mean 30. Mean 30. Mean EY 7 Age taveary) 73 178 oa 2 oat 128 WS (atthe stat) 2 Treatment’ 958 war ea 1.08 9.26 2a Ns ‘observation tine (rents) NS - Not signileant| 102 ‘Te Journal of Cincal Pediatrie Dentistry Volume 20, Number 2/1998Cephalometric evaluations Fig 1 The Bionator used in the study. both open and closed mouth position, ‘The condylar head was clearly visible in the open mouth position; hence tracing of the open mouth cephalogram was used to superimpose the head of condyle over the tracing of lateral cephalogram in cen- tric occlusion. ‘All the cephalograms were traced manually on ‘matte acetate tracing paper by single investigator and checked twice. All the landmarks then were identified and marked with a single dot (Fig. 2). A Hi-pad Digitizer interfaced with a PCC. was used for recording reference points determining linear and angular me surements and translated into an X-Y coordinate s tem, A customized computer program analyzed angu- lar and linear measurements for each radiograph. A modified FH plane that was constructed 7° to SN as used by Talass et al and Rains and Nanda." All the vertical measurements were recorded vertical to modi- fied Frankfort horizontal plane. The horizontal mei\- surements were recorded as vertical to FH through point $ (designated as FHp). The correction for magnification differences between successive cophalograms was deemed unnec~ essary because all paired radiographs were taken on 7 | | Fig. 2 Cephalometric landmarks used in the sty. same cephalostat. The intra- investigator digitizatior terror was assessed by retracing and digitizing 10 ran domly selected cephalograms on two separate occa sions. Dahlberg’s formula” was used to calculate th error: - sie Vs an d= difference between first and second reading: ‘number of models in the sample. ‘The mean standard error for linear measuremen’ was 0.37 mm and that for angular measurements Wi 026°. ‘One way ANOVA model was constructed to te the pretreatment values of all the variables in tt three groups. "To compare the pre- and post-treatment chang within each group, paired ‘t’ tests were employe Finally, one way ANOVA model again was used compare the mean treatment changes in three grouy {fa level of significance less than 0105 was observed multiple range test was used to determine the inte group significance. Wilcoxon Sign Runk Test (a 00 parametric test) was performed for some of the va ables showing large standard deviations, ime 9 Number B/90R 1-t Comparison of pretreatment variables Se Varable ‘Stepwise Bionator Therapy — Single Stop Bionator Th ‘Control No. ‘Group =I Group I! Group - I Mean so. Mean 80, Mean EY Cranat 1, SNA angle) 7a88 420 8.230 373 soar 3.05 2. SN angie) 81 377 76.45 ar 74.35 2.08 3, ANB (angle) 635, 425 524 18. 581 133 4 AO-B0 (rm) 587 115 3.90, 18 437 158 5. Ba-NtoPLGN angle 9050 334 39.28 430 90.82 272 Skeletal 8. Pa-FHplmm) 528 495 5033 129 55.0 588 7. AcFHptrm) 5.08 248, 58.25 3.48 87.03 4st 8 5-FHpmm) 52.59 436, 5887 522 55.88 562 8, Neem) 105.76, ozs 10077 Sas" 109.58 430 10, NeAnstnm) 51.38 247 4018 295 52.40 3.38 1. AnsMaim) 5437 00 58.58 5.05 57.18 332 12, S.Go(TPFH) 87387 452 046 826 7130 426 13. FMA(angle) 2695 335, 24.40 651 26.03 351 14 AnssicPm angie) a18t 482 2220 455 257 287 Mandibular 38, Cas-FHplmm) 13.86 339 nue 248 13.00 288 38. Cop-FHplmm) 1818 345, 1558 243, ta38 250 17. Cos-FH (ne) 1473 258 1822 22 2101 wrt 18. Cop-FHimm) 12.86 258 21.38 286 28.45 218 18. Go-Gofmm) S187 374 5198 802 48.04 283 20. go-Pgirm) 85.85 325 70.83 567 m1 582 21. XePgim) 64.05 478 85.40 435 8732 456 22, AnGo-Me angle) 12158 630 321.86 620 12328 745; Dental 23. Overitimm) 950 180 738 1.86 323 198 24. Overbiteimer) 702 337 474 12r 551 oss, 28. -FHpimm) 72.18 333, 7552 456 73.80 687 26. i-FHp(mm) 52.86 2a e797 3.40, 85.08 621 27. 1t0S-N (angle) n1341 ane saa q27 saat 62 28, 1 toMP langle) 10845 bis 103.21 480 101.33 519 28. ms-FHpimm) 381 228, 42.16 3.36 33.81 531 30, mkFHp(mm). 35.88 2a2 38.85 3.58 9842 530 31. 6-S-N angio) 8576 1224 7240 543 8397 537 32._6-MP (engl) 92.28 951 88.34 5.08, 08.78 350 “One way analysis of valance model reveals tht all the pretreatment RESULTS Pretreatment comparisons ‘Table Il shows the means and standard deviation of the pretreatment cephalometric values of the three groups. One way ANOVA revealed that the p value for all the variables was at the level of non-sigoif. cance, These finding indicated that the three groups were well matched in craniofacial morphology prior to treatment. Post-treatment comparisons ‘The treatment changes produced in the step-wise Bionator group and the single-step Bionator group were compared with the changes observed in control group after the same observation period of nine months. This comparison was made to take into account the growth changes that occurred during this Period and to determine the net changes produced by the individual treatment method, A comparison of net oe ‘The Journal of Cinical Pediatric Dentistry variables in these three groups are wall matched. treatment changes produced by step-wise Bionator therapy (Group 1) and single step Bionator therapy (Group 11) showed the following results (Table III). During treatment, the ANB angle was reduced more in the Group { (239°) than the Group IT, (1.84°) Group III showed increased ANB by 0.18°, There are clear differences in the means by which ANB is reduced in both the treatment groups. In Group I, a reduction of the ANB angle was brought about more by an increase in SNB (1.43°) than a decrease in SNA (0.95*), whereas, in Group Il the reduction was mainly due to'a decrease in SNA (1.07*). The Wits analysis corroborated the above findings, The sagittal position of the maxilla (A-FHp) was almost unchanged in both the treatment groups. However, the sagittal position of the mandible (B-FHp) showed greater improve- ment in Group I ie. by 2.50 mm.than Group II (1.89 mm), Similarly, Pogonion was positioned more for- ward in both the treatment groups, ie., by 2.25 mm in Group [ and by 2.01 mm in Group Hl, while in Group Volume 20, Number 21886oR a ace AU TIL it was almost unchanged. All of these changes were more in Group I, but were not significantly different than those of Group IL ‘There was no significant change in sagittal position of the condyles in both groups. ‘There was no significant difference in the increase in total anterior facial height (N-Me) in two groups. It ‘was 4.23 mm in Group I and 3.31 mm in Group Il. The increase in upper anterior facial height (UAFH) was identical in both the treated groups. The lower anteri- or facial height (LAFH) showed greater increase in Group I (3:20 mm) than Group Il (2.14 mm). The total posterior facial height also showed increases in both the treated groups, On inter-group comparison, no significant difference was seen in the two groups. The direction of mandibular growth remained unchanged in both the treated groups as no significant difference was found in the changes produced in facial Cephalometric evaluations axis angle (Ba-N to Pt-Gn), Y axis angle, (N-S-Gn) and FMA. The angle Ans-Xi-Pm increased more in Group I than Group I. This increase was attributed primarily to increase in lower anterior facial height, ‘These changes were not significant between the two sroups. ‘The overjet decreased in Step-wise group by 3.90 mm and in Single step group by 3.82 mm. Overbite reduced by 2.88 mm in Step-wise group and by 1.98 rnvin Single step group, however, there was no signif- icant difference in the two groups Changes produced in sagittal position of upper incisor (is-FHp) and lower incisor (ji-FEIp) also were not statistically significant on inter-group comparison, There was a statistically significant (P<0.05) increase in IMPA in Group II (2.03°) compared to Group I (0.28°). The changes in interincisal angle were not sta- Uistically different in two treated groups. ‘The net molar correction (ms/FHp-ms/FHp) was ‘Table &: Comparison of treatment changes with step-wise & single stop bionator therapy. 5 Varable Stopwise Bionator Therapy Single Stop Bionator Therapy Significance No @roup-I ‘roupI Mean so Maan so so vata tat Graniat 1. SNAIenge) 298 tors 07 ace 195 NS_NS NS 2. SNB angie) 1s soar 209 135 NS ONS NS 3. ANB (agi) 238 oss “188 10 ts 0 TONS 4 AQ-BO (mm) 3.82 ose “285 172 ONS 5. BeNIPLON angle “O15 ors oar 278 123° NSNS NS Skat 8. Pa-FHet) 225 208 201 180 os 258 NS NS NS 1. AeFopime) os 182 ons 133 08 093 NS ONS NS 8. B-FHfn) 250 131 139 153 2133 220° NSS 8. Net az 182 ast 098 205 22000 + NSN 40, Near) 103 ast a7 133, im 52500 ONS ONS 11, Anse) 320 110 216 098 028 tas = NS NS 12 S-Ga(TPrH 250 14 3.08, 108 un 223° NS NS NS 13, FMA angle) oss 133 a0 iz on 108 NS ONS ONS 14 AnsscPm lange) 073 125 a6 196 az a9 NS Manatuar 18, CosFHpimm) 0.18 179 oss 208 177 NS NS. NS. 18. Cop-FHoimm) 0.8 074 153 13 15é NS NS ONS 17. Gos-ehnm) O18 183 156 275 171 NSONS NS 18 CopFiinm) 0.50 183 aa 239 197 NS NSS 18 Co-Gofnm) 078 277 318 ize 130 NS 20. go-Ppimm) 202 436 an an 175 NS ONS NS 21. Fam) Sat 285 29 4.30 +00 NS_NS 22. AeGo-Me angi) 1.70 +86 199 «05 219 NS ONS NS Dental 23. Ovejstinm) 3.80 382 225 Ped Ns 24. Ovebisinm) 2.88 "198 185 405 Ns 25. s-FHolrin) 1.23 “182 103 222 NS NS NS 26. eEHp(mim) 250 228 486 10S 2 LtwSNtencl) §— 4.22 784 as 522 NS ONS NS 28. 1toMP angi) 028 200 03 21a NS 28. ms-FHipimm)——— 028 0s 2a 250 NS NS NS 230. meFRp(nm) 303 aur 208 2a ONS SN 6SNeenge) 18 308 473 560 NSS NS BeMParge) 086 2a7 a7 809 __NS_NS_NS INS No significance peas ~ peor W Peo<++ Pretreatment Post-reatment Pretreatment Fig. 9 Superimpostion ofa case treated with stepwise protusive activations, 2.85 mm in group I. The skeletal change (Pg-FHp) contributed 2.25 mm i. 78.94 % and pure dental was 0.60 mm i.e, 21.06%. In group II with single step Bionator therapy, the total net molar correction was 3.42. mm of this skeletal contribution was 2.01 mm (58.77%) and dental was 1.41 mm (41.23%). The changes in the inclination of upper molar (6-SN) as well as lower molar (6-MP) were not statistically sig- nificant between these two groups. The changes in the vertical position of upper molar (ms-SN) and lower molar (mi-MP) were not significantly different in the ‘wo treated groups, DISCUSSION Extensive studies on primates" and in human beings have demonstrated positively that appropri- ate functional or orthopedic appliances may stimulate and modulate the direction and quantity of jaw growth. Although several studies have been done in the past on the effects of increasing amount of vertical ‘opening of mandible by the functional appliances, yet only a few studies have evaluated systematically the effects of various amounts of activation. ‘These studies™* indicate that a single sagittal activa- tion of 5 mm or more results in more dentoalveolar changes: however, with progressive sagittal activation, skeletal changes predominate, To test this pre-supposi- tion, the present study was undertaken, In this study a significant improvement in dentofa- cial relationship was seen following treatment with Fig. 4. Superimpostion of a case treated with single step protu- sive activation Bionator in both the treatment groups. A number of orthopedic and orthodontic effects were similar in nature and the variations in the magnitude of these changes were small when the amount of protrusive functions varied. However, it was interesting to note that many of the dentoskeletal changes with step-wise protrusive activation were significantly different from those with single large protrusive activation (Table mm). ‘The Bionator was found to have a restraining and retracting effect (headgear effect) on the maxilla as, represented by a significant decrease in angle SNA in both the treatment groups. Op Heij and co-workers* also showed similar results with the use of the Bionator. The sagittal position of point A with respect to FH perpendicular also reconfirmed such an effect. However, the difference in the magnitude of such a change in the position of maxilla was not significant between step-wise and single step groups. This finding is in contrast to the findings of Falck and Frankel who in their study showed a restraining effect with step- wise protrusive activation and a retracting effect with single large activation A forward repositioning of point B and pogonion was seen in both the treatment groups. The magnitude of forward repositioning of mandible was greater in group I than in the group II. This difference can be explained on the basis of tissue response that probably is due to an initial neuromuscular adaptation to altered protrusion occlusion. which later is replaced by 106 “The Journal of GSnial Pacatie Dentistry Volume 20, Number 2/1986Cephalometric evaluations ‘Overt —Overbite.«110SN1toMP. Wl step-wise Gr. EBB single step Gr. contrat Fig. 5 Changes in angle B, KSN and 1 to MP, overt and overbite long-term skeletal adaptations” The orthopedic effects of stepwise mandibular advancement has been shown by using the Frankel appliance, the Herbst appliance? and the Bass" orthopedic corrector. Animal experi- ment by McNamara® has demonstrated that tonic dis- charge in the lateral pterygoid muscle, which increases dramatically with eppliance placement returns to nor- mal level after about 8 weeks. Thus. periodic forward repositioning of mandible was considered to be essen- tial for muscle reactivation. ‘The length of body of mandible (Go-Pg) showed 2 increase in Group 1 (2.02 mm) than in Group TI (0.71 mm). The present finding is in line with those found by (Op Heij and co-workers* and Awtade” in their studies using Bionator. Dahan et al.» also found significant increase in the body length of mandible with Bio-acti- vator treatment. The present study also showed a sig- nificant increase in Xi-Pg distance in Group I (3.8 mm) which was greater than that in Group II (2.49 mm). ‘The skeletal growth could be attributed to progressive sagittal activation, ‘There was a mild inferior movement of condyles in both the treatment groups which was more in group 11, though statistically not significant, Mamandras and Allen,” Awtade® and Op Heij and co-workers also reported inferior condylar displacement with Bionator therapy. In a recent study Falck and Frankel.‘ found no significant condylar positional change in the patients treated by progressively activated Frankel applian but in the patients with single large activation a signi cant condylar displacement was noted. These findings are in league with the present findings ‘A significant increase in lower facial height (ANS- xi-Pm, ANS-Me) was observed in both the treatment _0Ups compared to controls, On intra group compari- son between groups (j.e., I & Il) differences were not significant. These findings are supported by an earlier study” on functional appliances. ‘The Journal of Cea Pediatric Dentistry Volume 20, Number 2/1996 ANE Hl Step-wise Ge [3] Single Step Ge xAPg Goo (Coontret Fig 6. Overall skeletal changes in angle ANB, N-P9, GoPe. The direction of mandibular growth remained almost unchanged as shown by very small changes in facial axis angle (Ba-N to Pt-Gn), ¥ axis angle (S: Gn) and angle FMA. Studies by Awtade." Op Heij and co-workers? Falck and Frankel have shown a mild posterior growth rotation of mandible when the sagit- tal activation was large. We also observed least cha in the sagittal position of condyle measured Cop- Fp in stepwise protrusion cases, whereas in single step, these measurements were larger. therapy con firming the postural rotation of condylar head. Landt™ suggested that gradual training of s: ing musculature by step-wise protrusive activations eliminates the growth restraining signals in ab way than a sudden change in the postural behavie: © the muscles. Thus itis evident from the preser: that the mandibular basal bone development wise group was significantly stimulated sag which resulted in an improvement of the initia lationship between maxilla and mandible, ‘The original postural relationship position o condyles was maintained. Therefore, it can be a: that a functional harmony between the conds': tion and jaw relationship was not disturbed ¢: treatment with Bionator more so in Step-wise gro ‘There was a marked but similar amount of = tion of overjet in both the treatment groups. mechanism of such a change differed. In gro: skeletal (79%) correction was predominant o dental (21 %) correction, (Fig. 7) while in Gro: was (59 %) and (41 %) respectively (Fig. 8) ‘These observations call for a long term fo: study to further evaluate the stability of the produced by various modes of sagittal as well v activations by functional appliances.‘Skeletal 2.25 73 Dental 0.8 Skeletal 2.01 Ey Dental Fig. 7 Sagittal molar corection in step-wise bionator therapy CONCLUSIONS ‘The following conclusions were drawn from the findings of this study: 1, Bionator therapy is an effective mode of treat- ‘ment for the correction of Class II Division 1 maloc- clusion in growing children. 2. 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