ORIGINAL ARTICLE. Luis Monasterio, M.D., Alison Ford, M.D., Carolina Gutiérrez, D.D.S, María Eugenia Tastets, R.N., Jacqueline García, R.N.

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1 The Cleft Palate-Craniofacial Journal 50(5) pp September 2013 Ó Copyright 2013 American Cleft Palate-Craniofacial Association ORIGINAL ARTICLE Comparative Study of Nasoalveolar Molding Methods: Nasal Elevator Plus DynaCleftt Versus NAM-Grayson in Patients With Complete Unilateral Cleft Lip and Palate Luis Monasterio, M.D., Alison Ford, M.D., Carolina Gutiérrez, D.D.S, María Eugenia Tastets, R.N., Jacqueline García, R.N. Objective: To compare nasoalveolar molding (NAM) effect employing a nasal elevator plus DynaCleftt and NAM-Grayson system in patients with complete unilateral cleft lip and palate. Method: Prospective study in two groups. Group A included 20 consecutive patients treated with DynaCleftt and a nasal elevator before lip surgery. Group B included 20 patients treated with NAM-Grayson system. Maxillary casts and standard view photographs were done before and after treatment. Columella deviation angle, soft tissue distance of the cleft, intercommisural distance, and nostril height and width were traced and measured on the printed photos; a ratio was obtained and compared before and after treatment. Cleft width, anterior width, and anteroposterior distances were measured on the maxillary cast. Results: Group A began treatment at an average age of 14.3 days and group B at an average age of 16.9 days; no complications were observed. For group A, the initial average alveolar cleft within the cast was 10.7 mm, and after treatment it was 6.6 mm. For group B, pretreatment width was 11.2 mm, and after treatment it was 5.9 mm. No differences were found on the anterior and posterior width, and A-P distance of both groups. The initial mean columellar angle in group A was 38.18, and after treatment it was 61.58; for group B the initial mean columellar angle was 33.68, and after treatment it was Results of Mann-Whitney U and Student s t tests showed no differences (P..05). Width and height dimensions of the nostril showed minor differences. Conclusions: Both methods significantly reduced the cleft width and improved the nasal asymmetry. Our findings show that both methods produced similar results. KEY WORDS: columellar angle, nasoalveolar molding Nasoalveolar molding is a procedure that is commonly used in many centers for improving cosmetic and functional aspects of the nose and maxilla before surgery in patients with unilateral and bilateral cleft lip and palate (CLP). Modern presurgical procedures began with McNeil in He used buccal plates to mold the segments into the desired position. Matsuo et al. (1989) were the first to describe a nonsurgical method to correct the nasal deformity, using silicone tubes to mold the nostril. Later, Dogliotti et al. (1991) and Grayson et al. (1993), using the same principle of Dr. Monasterio is Plastic Surgeon, Director of Fundaci on Gantz, and staff, Cl ınica Alemana, Santiago, Chile. Dr. Ford is Plastic Surgeon, Fundaci on Gantz, and staff, Cl ınica Las Condes, Santiago, Chile. Dr. Guti errez is affiliated with Fundaci on Gantz, and staff, Hospital Roberto del R ıo,santiago,chile.ms.tastets and Garc ıa are affiliated with Fundaci on Gantz, Santiago, Chile. The manuscript was presented orally at the ACPA meeting, Puerto Rico, April 4 9, Submitted October 2011; Revised February 2012; Accepted June Address correspondence to: Dr. Luis Monasterio, El Lazo 8545, Pudahuel, Santiago, Chile. eleemedr@hotmail.com. DOI: / the high degree of plasticity of the nasal cartilage in the neonatal period, introduced an intraoral molding plate with nasal stents to align the alveolar ridges and to model the nasal cartilage (NAM). Berggren (2001) and Berggren et al. (2005) used a different approach adhesive paper tape and a nasal elevator to improve the morphology of the nose before the surgery. Inspired by this method, in 2002 we began to use a simple nasal elevator made with a paper clip lined with plastic, and an elastic band fixed to the forehead, combined with paper tape to approximate the cleft edges (Monasterio et al., 2008). In 2009, trying to avoid the intraoral plate and simplify the procedure, the paper tape was replaced by paper tape with an elastic band (DynaCleftt, Canica Design Inc., Almonte, Ontario, Canada). In our institution, we began preoperative orthopedics 20 years ago with the Latham appliance, which we used for several years. We then changed to the NAM-Grayson method for 10 years and have used the nasal elevator associated with DynaCleftt for the past 3 years. The purpose of the present study was to determine in a comparative analysis the effect of presurgical molding of 548

Monasterio et al., COMPARATIVE STUDY OF NASOALVEOLAR MOLDING 549 FIGURE 1 A 2-month-old patient with a complete left cleft lip and palate treated with nasal elevator and DynaCleftt from 7 days of age.

until lip and nose surgery. PATIENTS AND METHODS This study was approved by the Ethics Committee of Fundación Gantz, and the protocol of treatment was in accordance with the Declaration of Helsinki.

You may observe the oral plate and the nasal antenna. patients parents.

Group A received presurgical treatment with the nasal elevator device and DynaCleftt for 3 months before lip surgery (2009 to 2010).

2 Monasterio et al., COMPARATIVE STUDY OF NASOALVEOLAR MOLDING 549 FIGURE 1 A 2-month-old patient with a complete left cleft lip and palate treated with nasal elevator and DynaCleftt from 7 days of age. two different methods of treatment NAM-Grayson and nasal elevator plus an elastic band (DynaCleftt) in a series of 40 nonsyndromic patients with complete unilateral CLP, from the neonatal period until lip and nose surgery. PATIENTS AND METHODS This study was approved by the Ethics Committee of Fundación Gantz, and the protocol of treatment was in accordance with the Declaration of Helsinki. Photographs and participation in the study were authorized by the FIGURE 3 A 3-month-old patient with a complete left cleft lip and palate treated with NAM-Grayson method from 2 weeks of age. You may observe the oral plate and the nasal antenna. patients parents. A prospective study was designed to compare two methods of presurgical orthopedics in two groups of 20 unilateral CLP patients who were treated at Fundación Gantz (Santiago, Chile). Group A received presurgical treatment with the nasal elevator device and DynaCleftt for 3 months before lip surgery (2009 to 2010). Group B received the presurgical NAM-Grayson technique for 3 months before primary lip and nasal surgery (2007 to 2009). The average age of the patients was comparable in both groups. All patients were seen in the newborn period. After the clinical examination, an impression with silicone elastomer was taken with the patients awake, in prone FIGURE 2 Nasal elevator is made from a plastic-coated paper clip that is bended in the desired shape; the tip is covered with Teflon tape. The device is connected with an orthodontic elastic band (Dentaurum, 7.94 mm, 5/16 inch diameter) and fixed to the frontal area with tape. FIGURE 4 Measurements in millimeters on maxillary cast model. a: Cleft width. b: Transversal width. c: Antero-posterior length.

550 Cleft Palate-Craniofacial Journal, September 2013, Vol. 50 No. 5 FIGURE 5 Photograph measurements of the columellar angle in a patient with complete left cleft lip and palate.

3 550 Cleft Palate-Craniofacial Journal, September 2013, Vol. 50 No. 5 FIGURE 5 Photograph measurements of the columellar angle in a patient with complete left cleft lip and palate. The columellar angle was 278 before treatment and changed with the nasal elevator to 538. FIGURE 6 Measurement of nostril width in the same patient. You may observe the improvement before and after treatment. FIGURE 7 Changes of the nostril width before and after treatment. position. Maxillary models were obtained at the beginning of the treatment and before lip surgery. Group A patients at the time of the first consultation used nasal elevator and DynaCleftt (Fig.1).Thisnasaldeviceismadefroma plastic-coated paper clip, which is bent into the required shape. Its tip is covered with Teflon tape for adequate cushioning and volume. In Figure 2, you may observe details of the nasal elevator. There is an orthodontic elastic band (Dentaurum, 7.94 mm, 5/16 inch diameter; Munich Germany)fortractionfixedwithtapetotheforeheadinthe adequate vector. Tension was measured with a dynamometer; one ounce of tension was enough, and slight blanching of the skin was observed. The parents were instructed on how to use and replace the DynaCleftt (every 3 to 4 days) and how to clean or change the Teflon cover of the nasal elevator every day and regulate the degree of tension required, observing any skin irritation of the nostril. The alveolar plate in group B was obtained from the plaster

4 Monasterio et al., COMPARATIVE STUDY OF NASOALVEOLAR MOLDING 551 FIGURE 8 Measurement of the relationship between the width of the soft tissue cleft and the intercommisural distance of the mouth, before and after treatment. You may observe a clear improvement in the relationship between the two distances. This patient was treated with DynaCleftt and nasal elevator. models using acrylic resin and was retained with surgical adhesive paper tape attached to both cheeks. One month later, a nasal stent was added (Fig. 3). Children were seen on a weekly basis to check the nasal elevator and replace the DynaCleftt in group A and to modify the plate in group B. Landmarks were marked on the maxillary cast models; cleft width, anterior arch width, andarchlengthweredone(fig.4).standardanteriorposterior and worms-eye view photographs were taken and printed in cm size, before and after treatment. The following measurements were taken (Figs. 5 through 8): columellar deviation angle, nostril width and height, intercommisural distance, and soft tissue cleft width. Linear measurements were done with a ruler and registered in millimeters; a goniometer was used to measure columellar angles. A ratio was obtained for the cleft and noncleft nostril. To evaluate the improvement in the size of the soft tissue cleft, a ratio was calculated between the size of the mouth (intercommisural distance) and the soft tissue cleft. We consider that the cleft width in the maxillary cast and the columellar angle are the most objective measurements. A statistical comparative analysis with the Mann-Whitney U test for independent sample wasusedtocompareresults between both groups. To show the difference in columellar angle and cleft width, the Student s t test was used for independent samples of the variables in both groups. RESULTS Figures 9 and 10 show a demonstrative case of each group and the changes in the nose and the maxillary cast over the course of treatment. Table 1 summarizes the demographic data of all cases. FIGURE 9 Patient with a complete left cleft lip and palate treated with nasal elevator and DynaCleftt. The treatment began at 7 days of age. a: Face and the maxillary cast before treatment. b: Nasal elevator and DynaCleftt. c: Result of treatment at 3 months of age, before the surgery.

552 Cleft Palate-Craniofacial Journal, September 2013, Vol. 50 No. 5 FIGURE 10 Patient with a complete right cleft lip and palate treated with NAM-Grayson. The treatment began at 10 days of age.

5 552 Cleft Palate-Craniofacial Journal, September 2013, Vol. 50 No. 5 FIGURE 10 Patient with a complete right cleft lip and palate treated with NAM-Grayson. The treatment began at 10 days of age. a: Face and the maxillary cast before treatment. b: NAM-Grayson appliance. c: Result after 4 months of treatment, before the surgery. Both groups have the same number of patients and similar gender distribution. Presurgical average treatment started 2.5 days later in group B because a few more days were required to fabricate the buccal plate. In group A, the TABLE 1 Demography Nasal Elevator and DynaCleftt (Group A) NAM-Grayson (Group B) Number of patients Male Female 5 6 Initial age, days Age posttreatment, days nasal elevator and DynaCleftt were installed during the first consultation. Both groups were treated for more than 3 months. Group B patients were treated for 2 additional weeks. Table 2 summarizes the three measurements made on the maxillary cast in both groups. Table 3 shows the results of the measurements made on photographs. Both groups showed an important improvement in all parameters studied. The most objective measurements were cleft width and columellar angle. The results are in Table 4. TABLE 2 Maxillary Cast Measurements Nasal Elevator and DynaCleftt (Group A) NAM-Grayson (Group B ) Cleft width average, mm Initial 10.7 (63.8) 11.2 (63) Post 6.6 (63.4) 5.9 (62.6) Anterior arch width average, mm Initial Post Arch length (A-P) average, mm Initial Post TABLE 3 Photograph Measurements Nasal Elevator and DynaCleftt (Group A) NAM-Grayson (Group B) Columellar angle, degrees Initial (37.5 median) (34 median) Post (61.5 median) (60 median) Nostril width ratio Initial Post Nostril height ratio Initial Post Soft cleft ratio Initial Post 6.6 6

6 Monasterio et al., COMPARATIVE STUDY OF NASOALVEOLAR MOLDING 553 TABLE 4 Results of Cleft Width and Columellar Angle Nasal Elevator and DynaCleftt (Group A) NAM-Grayson (Group B) Minimum Maximum X 6 SD Median Minimum Maximum X 6 DS Median Initial columellar angle, degrees Post columellar angle, degrees Initial cleft width, mm Post cleft width, mm Statistical analyses were done comparing both groups. Mann-Whitney U test for independent samples was used to demonstrate the nullity of differences of the studied variables. Table 5 shows a summary of this. The analysis showed no statistical differences (P..05) in both groups for columellar angle and alveolar cleft width. Table 5 shows statistical analysis (Student s t test) of the differences of the variables between both groups. DISCUSSION Presurgical nasoalveolar molding treatment has been adopted by a great number of multidisciplinary cleft teams around the world convinced of the benefits for cleft lip and nose primary surgery (Bennun et al., 1999; Liou et al., 2004; Barillas et al., 2009; Grayson and Shetye, 2009; Suri, 2009); all of these cleft teams use minor variations of the NAM- Grayson procedure. We have used presurgical orthopedics with NAM for many years with limitations imposed by the small number of orthodontists trained in the procedure and the cost. Looking for alternative treatment protocols, we designed the nasal traction device, which we complemented with the DynaCleftt band in search of a new and simpler way of providing presurgical molding. We have had good compliance from the parents with this treatment and no complications derived from the dislodgement of the nasal device in more than 600 patients with the device. The results of this study show that both nasoalveolar molding methods are effective. They improve the altered nasal anatomy and reduce the size of the maxillary cleft in patients with complete unilateral CLP. The NAM-Grayson system guides maxillary alveolar changes acting directly on the maxillary flange. DynaCleftt acts indirectly on the maxillary segments by the force vectors generated by the gentle traction of the lip muscles. We recommend the use of TABLE 5 Statistical Analysis (Student s t Test and Mann- Whitney U test) of Variable Differences Between Both Groups Difference Between Nasal Elevator and DynaCleftt and NAM-Grayson Z Value Bilateral Probability Value* Cleft width, mm Initial Post Total difference Columellar angle, degrees Initial Post Total difference * P..05. the nasal traction device with the DynaCleftt band as a comparable alternative for presurgical treatment in complete unilateral CLP. The advantages of nasal appliance and the DynaCleftt method in our experience are: 1. It is less invasive because it does not require an oral plate and generates less nostril airway reduction. 2. It is less expensive. In our institution, the cost of treatment with NAM is approximately $500. The Dyna- Cleftt with a nasal elevator device costs $ A dental specialist is not required. The follow-up is done by nurses once a week and by the surgeon every 2 weeks. 4. It is easier for the parents to understand and manage. 5. We have had no remarkable complications. There is a potential risk of swallowing the nasal elevator, though we have not observed this accident in more than 600 patients. An adverse skin reaction to the tape is observed sometimes, but this can be resolved by stopping the treatment for a few days. We have also used the nasal elevator during the postoperative period of lip and nose surgery but have not observed any complications. The senior author has dedicated 40 years to the treatment of patients with CLP. Over this period, he and his team have had extensive experience using several methods of presurgical orthopedics. Considering his years of expertise, the lead author has stated that, If I was an infant with a complete unilateral CLP, and soon after my birth someone would place an appliance inside my mouth, a nasal antenna which would obstruct my nasal passage, and cover around my mouth with paper tape, I would certainly not be a happy baby. Acknowledgment. The authors had no financial interest in any of the products or devices mentioned in this article. The DynaCleftt used was donated for the purpose of the study by Canica Design Inc. REFERENCES Barillas I, Warren S, Cutting C, Grayson B. Nasoalveolar molding improves long-term nasal symmetry in complete unilateral cleft lipcleft palate patients. Plast Reconstr Surg. 2009;123:1002. Bennun R, Perandones C, Sepliarsky V, Chantiri S, Ulfe I, Dogliotti P. Non-surgical correction of nasal deformity in unilateral complete cleft lip: a 6-year follow-up. Plast Reconstr Surg. 1999;104:616. Berggren A. Surgical tape and the nasal alar elevator two simple and useful tools in the early preoperative treatment of cleft lip patients. Presented at the International Congress of Cleft Lip-Palate and Craniofacial Anomalies; June 25 29, 2001; Goteborg, Sweden.

7 554 Cleft Palate-Craniofacial Journal, September 2013, Vol. 50 No. 5 Berggren A, Abdiu A, Marcusson A, Paulin G. The nasal alar elevator: an effective tool in the presurgical treatment of infants born with cleft lip. Plast Reconstr Surg. 2005;115: Dogliotti P, Bennun R, Losovic E. Tratamiento no quirúrgico de la deformidad nasal en el fisurado. Rev Ateneo Argen Odontol. 1991;27:31. Grayson B, Cutting C, Wood R. Preoperative columella lengthening in bilateral cleft lip and palate. Plast Reconstr Surg. 1993;92: Grayson B, Shetye P. Presurgical nasoalveolar moulding treatment in CLP patients. Indian J Plast Surg Supplement. 2009;42(suppl):S56 S61. Liou E, Subramanian M, Chen P, Huang S. The progressive changes of nasal symmetry and grow after nasoalveolar molding: a threeyear follow-up study. Plast Reconstr Surg. 2004;114:858. Matsuo K, Hirose T, Otagi T, Norose N. Repair of cleft lip with no surgical correction of nasal deformity in the early neonatal period. Plast Reconstr Surg. 1989;83:25. Monasterio L, Munoz M, Bennun R. Tratamiento Interdisciplinario de las Fisuras Labio-Palatinas. Santiago: Luis Monasterio Aljaro; 2008: Suri S. Design features and simple methods of incorporating nasal stents in presurgical nasoalveolar molding appliances. J Craniofac Surg. 2009;20(suppl 2):

Dynamic Presurgical Nasal Remodeling in Patients With Unilateral and Bilateral Cleft Lip and Palate: Modification to the Original Technique

IDEAS AND INNOVATIONS Dynamic Presurgical Nasal Remodeling in Patients With Unilateral and Bilateral Cleft Lip and Palate: Modification to the Original Technique Ricardo D. Bennun, M.D., M.S., Ph.D., Alvaro