PEDIATRIC/CRANIOFACIAL Nasoalveolar Molding Improves Appearance of Children with Bilateral Cleft Lip–Cleft Palate Catherine T. H. Lee, B.D.S. Judah S. Garfinkle, D.M.D., M.S. Stephen M. Warren, M.D. Lawrence E. Brecht, D.D.S. Court B. Cutting, M.D. Barry H. Grayson, D.D.S. New York, N.Y. Background: Bilateral cleft lip– cleft palate is associated with nasal deformities typified by a short columella. The authors compared nasal outcomes of cleft patients treated with banked fork flaps to those of patients who underwent nasoalveolar molding and primary retrograde nasal reconstruction. Methods: A retrospective review of 26 consecutive patients with bilateral cleft lip– cleft palate was performed. Group 1 patients (n ⫽ 13) had a cleft lip repair and nasal correction with banked fork flaps. Group 2 patients (n ⫽ 13) had nonsurgical columellar elongation with nasoalveolar molding followed by cleft lip closure and primary retrograde nasal correction. Group 3 patients (n ⫽ 13) were age-matched controls. Columellar length was measured at presentation and at 3 years of age. The number of nasal operations was recorded to 9 years. The Kruskal-Wallis and Tukey-Kramer tests were used for statistical analysis. Results: Initial columellar length was 0.49 ⫾ 0.37 mm in group 1 and 0.42 ⫾ 0.62 mm in group 2. Post–nasoalveolar molding columellar length was 4.5 ⫾ 0.76 mm in group 2. By 3 years of age, columellar length was 3.03 ⫾ 1.47 mm in group 1, 5.98 ⫾ 1.09 mm in group 2, and 6.35 ⫾ 0.99 mm in group 3. Group 2 columellar length was significantly greater (p ⬍ 0.001) than that of group 1 and not statistically different from that of group 3 (p ⬎ 0.05). All group 1 patients (13 of 13) needed secondary nasal surgery. No nasoalveolar molding patients (zero of 13, group 2) required secondary nasal surgery. Conclusion: Nonsurgical columellar elongation with nasoalveolar molding followed by primary retrograde nasal reconstruction restored columellar length to normal by 3 years and significantly reduced the need for secondary nasal surgery. (Plast. Reconstr. Surg. 122: 1131, 2008.) B roadbent and Woolf1 and Millard2 described the bilateral cleft lip– cleft palate deformity as a condition in which the prolabium and premaxilla are suspended from the tip of the nasal septum and the lateral alveolar segments and lip elements remain behind. The severe anterior projection of the premaxilla and footplates of the medial crura, combined with tethering of the lateral crura, pulls the nasal domes widely apart and down into the lip.3 The lateral displacement of the alar cartilage domes contributes to a widened alar base, flattened nose, and a short or absent columella. Finally, the muscle-free prolabium seems to draw the foreshortened columella down, widening and distorting the nostrils (Fig. 1, left). From the Institute of Reconstructive Plastic Surgery, New York University School of Medicine. Received for publication July 30, 2007; accepted February 15, 2008. Copyright ©2008 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0b013e318184590c Treatment strategies for bilateral cleft lip– cleft palate nasal deformity hinged on the observation that the columella was short or absent but the skin of the prolabium was excessively wide. Millard hypothesized that excess prolabial skin could be stored and then used later to construct a columella.4 In 1971, Millard tested this hypothesis and proved that prolabial skin could be banked in the nasal sill/floor and then elevated to increase columellar length in a second surgical procedure.4 Many surgeons modified this technique, but all modifications require at least two Disclosure: The authors hereby certify that, to the best of their knowledge, no financial support or benefits have been received by any coauthor, by any member of their immediate families, or by any individual or entity with whom or with which they have a significant relationship from any commercial source that is related directly or indirectly to the scientific work reported on in this article. www.PRSJournal.com 1131 Plastic and Reconstructive Surgery • October 2008 Fig. 1. (Left) Initial presentation of the nose/lip deformity in bilateral cleft lip– cleft palate. Note the hypoplastic columella, splayed nasal domes and alar wings, and an inferior location of the nostril apices. (Center) Typical appearance of the nose following treatment with nasoalveolar molding. Note the elongated columella, improved nasal tip projection, corrected alar wing position, and improved nostril aperture orientation. (Right) View of a patient after primary retrograde nasal reconstruction of correction of the lip and alveolar deformities. operations.5–7 For example, 3 to 5 years after primary lip repair, Koh and Ock created interdigitating triangular flaps to simultaneously increase columellar length and create a pyramidal columellar base.5 Other surgeons developed longforked, short-forked, and three-quarter-length forked flaps. Cronin and Upton described early banked fork flap columellar reconstruction—the second stage was only 3 to 7 months after primary lip repair.8 Collectively, banked fork flap outcomes were characterized by large nostrils, a scarred columella, a columellar kink under the nasal tip, poor nasal tip projection, and widely separated dome cartilages (Fig. 2). Moreover, scars at the lip-columella junction produced an abnormally acute lip-columella angle that was difficult to revise. In recent years, new techniques were developed to correct bilateral cleft lip– cleft palate and nasal deformities. McComb was the first to address the nasal tip cartilage deformity during the primary repair of the lip, but his technique required two stages.9 The development of a primary nasal correction for bilateral cleft lip– cleft palate patients was based on contributions from a number of surgeons, including Mulliken, Trott and Mohan, Cutting et al., and Talmant et al.10 –22 In 1998, Cutting and Grayson developed a bilateral cleft lip– cleft palate nasal repair based on nonsurgical lower lateral cartilage molding and columellar elongation.23 The authors combined the ear/nasal cartilage molding technique of Matsuo et al. and the unilateral cleft lip nasoalveolar molding technique developed at New York University Medical Center to create a one-stage surgical treatment for bilateral cleft lip– cleft palate nasal deformity.23–25 Fig. 2. Typical appearance of patients following a banked fork flap procedure. Note the large nostrils, scarring of the columella, columellar kink under the nasal tip, poor nasal tip projection, and widely separated dome cartilages. Secondary nasal revision was recommended with these types of outcomes. 1132 Volume 122, Number 4 • Nasoalveolar Molding The purpose of the retrospective study presented here is to compare the long-term stability of columellar length and shape of bilateral cleft lip– cleft palate patients treated with a banked fork flap technique or nasoalveolar molding and primary nasal correction to normal age-matched controls. Because the columella is profoundly deficient in bilateral cleft lip–cleft palate patients, we use columellar length and shape as a central measure of successful treatment. We also compared the number of secondary nasal operations necessary to achieve a satisfactory nasal shape up to 9 years of age. PATIENTS AND METHODS Demographics and Treatment Protocols All patients were treated between 1992 and 1997 at the Institute of Reconstructive Plastic Surgery, New York University Medical Center, by the same orthodontist (B.H.G.) and surgeon (C.B.C.). All treated patients had complete bilateral cleft lip with or without cleft palate and were at least 9 years of age at the time of analysis (2006). All children were followed to at least 9 years of age to record or make a clinical decision on the need for secondary nasal correction. Although bilateral cleft lip– cleft palate patients are followed for a lifetime at our institute, 9 years of age represents the upper age limit for alveolar bone grafting and therefore the last essential point of contact for some of our patients. To reduce the follow-up or surveillance bias, we chose to evaluate our nasal outcomes during this essential clinic visit for assessment of the alveolar bone. Patients were divided into three groups. Group 1 consisted of 13 consecutive bilateral cleft lip– cleft palate (eight boys and five girls) treated with the two-stage Millard-type banked fork flap method. Primary lip and nose repair was performed on average at 3.9 months (range, 3 to 8 months). Forked flaps were elevated and inset on average at 2.1 years (range, 1 to 3.4 years). Group 2 consisted of 13 consecutive bilateral cleft lip– cleft palate patients (eight boys and five girls) treated with presurgical nasoalveolar molding and columellar elongation for an average of 4 months (range, 2 to 6 months), followed by lip repair and primary retrograde nasal reconstruction. Nasoalveolar molding therapy has been described previously by Grayson et al.26 Briefly, serial adjustments of an acrylic maxillary molding plate gradually approximated the premaxilla and alveolar segments. The nasal stents were added when the alveolar gaps were reduced to 5 mm. Sequen- tial adjustment of the nasal stents approximated the nasal domes, improved tip projection, defined the nostril apertures, and lengthened the columella (Figs. 3 and 4). Nasoalveolar molding therapy was complete when patients achieved a 3- to 6-mm long columella with satisfactory nasal symmetry, tip projection, and lip/alveolar segment alignment (Fig. 1, center). After nasoalveolar molding therapy, all patients underwent Cutting-type bilateral cleft lip closure, Millard-type gingivoperiosteoplasty, and Cutting-type primary retrograde nasal reconstruction at an average of 5 months of age (range, 3.5 to 7 months of age).27 Primary retrograde nasal reconstruction included the removal of interdomal fibroadipose tissue, interdomal sutures, nasal base cerclage, and columellar-tip complex anterior advancement along the membranous septum (Fig. 1, right).23 Fig. 3. A bilateral cleft lip nasoalveolar molding appliance. Note the bilateral nasal stents and horizontal columella band. In addition, there are two retention buttons that engage a pair of surgical adhesive tapes and orthodontic elastics. Fig. 4. Nasoalveolar molding appliance in situ. 1133 Plastic and Reconstructive Surgery • October 2008 Group 3 consisted of 13 age-matched patients (seven boys and six girls) without lip or nose abnormalities who presented to our clinic with other problems (e.g., spina bifida, extremity burns). The average age was 2.9 years (range, 1.7 to 4.1 years). Photometric Measurements The photometric technique used to evaluate columellar length in all three groups has been described previously.28 Black-and-white photographs in frontal, lateral, and basilar views were used to identify the subnasale, highest point of the columella, and the medial canthus (Fig. 5).29 The basilar view photographs were then used to determine the columellar length. To eliminate magnification error, the basilar view photographs of all the subjects were first size-adjusted to the same intercanthal distance. A ratio of columellar length to the standardized intercanthal distance was then established. The actual columellar length (in millimeters) was then obtained by multiplying this ratio by the actual intercanthal distance for a child of any given age as defined by Farkas29: Actual columellar length 冉 ⫽ Photometric columellar length Photometric intercanthal distance 冊 ⫻ Farkas intercanthal distance In some children, in whom one of the medial canthi was obstructed by the nasal tip in the basilar view photograph, intercanthal distances were obtained by using an indirect method. For the frontal view photographs, the ratio of intercanthal width and alar base width was obtained for each patient. For the basilar view, this ratio was applied to alar base width to obtain the intercanthal distance. All measurements were performed independently by two of the authors (B.H.G. and L.E.B.). Interobserver and intraobserver variance was measured to determine measurement reliability of randomly selected cases. The measurements were analyzed with regression analysis (Pearson’s correlation) for interobserver and intraobserver variance and photograph reliability. It is important for the reader to note that the photogrammetry used in this study has certain limitations.14 Clinical Assessment In addition to photometric measurements, postsurgical nasal results were evaluated by a board-certified plastic surgeon (C.B.C.), a craniofacial orthodontist (B.H.G.), and a prosthodontist (L.E.B.). Because validated standardized instruments to measure nasal aesthetics do not exist, outcomes were subjective. Descriptive terms used to characterize the tip of the nose included wellformed, flat on one side, bilaterally flat, and bifid. The shape of the ala was described as normally curved and symmetrical on both sides, flat, angled on one side or both sides, or flat on one side and angled on the other. The nostrils were defined as symmetrical in size or with one nostril larger or smaller. Collectively, these subjective measures were used to determine the need for secondary nasal surgery. Statistical Analysis All results are reported as mean ⫾ SD. A t test was used to compare control columellar length at 3 years of age in our study to columellar length of 3-year-olds reported by Farkas et al.30 Next, a nonparametric Kruskal-Wallis test was performed to determine whether a difference existed among the three groups. Finally, a Tukey-Kramer multiple comparisons test was used to compare columellar length between all three groups at 3 years of age. A value of p ⬍ 0.05 was considered statistically significant. RESULTS Fig. 5. Photometric technique with basilar view used to identify the following soft-tissue points: subnasale (sn), highest point of the columella (c’), and medial canthus (en). 1134 Validating Columellar Measurement The method used to measure and normalize the columellar length in our study was validated by comparing the mean columellar length of the control group (6.35 ⫾ 0.99 mm) with the mean columellar length of 3-year-old children reported by Farkas et al. (6.40 ⫾ 1.2 mm).30 A t test demon- Volume 122, Number 4 • Nasoalveolar Molding strated that the columellar length of the children in our control group was not statistically different from the columellar length reported by Farkas et al. (p ⫽ 0.48).30 Pre–Nasoalveolar Molding and Preoperative Columellar Length Columellar length at presentation (average, 3.2 weeks of life) was 0.49 ⫾ 0.37 mm in group 1 and 0.42 ⫾ 0.62 mm in group 2. The initial columellar lengths of group 1 and group 2 patients were not statistically different (p ⫽ 0.73). Post– nasoalveolar molding (average, 5.5 months) columellar length was 4.5 ⫾ 0.76 mm in group 2. Postoperative Columellar Length The columellar length of all three cohorts at 3 years of age was as follows: the banked fork flap– treated patients (group 1) measured 3.03 ⫾ 1.47 mm; the nasoalveolar molding–treated patients (group 2) measured 5.98 ⫾ 1.09 mm; and the agematched controls (group 3) measured 6.35 ⫾ 0.99 mm. The Kruskal-Wallis test demonstrated that a significant difference existed among the three groups (p ⬍ 0.0001). The Tukey-Kramer multiple comparisons test demonstrated a significant increase (p ⬍ 0.001) in the columellar length of patients treated with nasoalveolar molding and primary nasal surgery (group 2) compared with patients treated with banked fork flaps alone (group 1). Statistical analysis also demonstrated that patients treated with banked fork flaps alone (group 1) had significantly shorter columellar length (p ⬍ 0.001) compared with age-matched controls (group 3). Finally, no statistically significant difference (p ⬎ 0.05) was found between patients treated with nasoalveolar molding (group 2) and the agematched controls (group 3) (Table 1). Table 1. Columellar Length at 3 Years of Age Patient 1 2 3 4 5 6 7 8 9 10 11 12 13 Mean ⫾ SD Group 1 (mm) Group 2 (mm) Group 3 (mm) 1.66 1.62 3.52 3.67 4.82 1.21 4.91 4.78 4.11 2.17 2.62 0.62 3.66 3.03 ⫾ 1.47 6.78 6.61 5.75 5.61 7.00 6.15 7.46 7.48 4.75 4.35 6.28 4.35 5.14 5.98 ⫾ 1.09 7.34 7.92 7.55 4.89 6.58 6.35 6.48 6.40 6.37 4.52 5.80 6.22 6.16 6.35 ⫾ 0.99 Secondary Columellar Surgery Secondary rhinoplasty was recommended for all of the children (100 percent) in group 1. A typical forked flap–treated patient is presented in Figure 2. Eight of the group 1 patients (61.5 percent) actually had a nasal reconstruction performed between the ages of 7 and 9 years. In group 2, secondary surgical columellar elongation was not recommended for any of the children (Fig. 6). DISCUSSION Bilateral cleft lip– cleft palate nasoalveolar molding is designed to align alveolar segments, restore lower lateral cartilage position, and increase columellar length. To achieve optimum results, nasal molding and columellar elongation should follow alveolar segment correction. By orderly restoration of nasoalveolar anatomy, the craniofacial orthodontist/surgeon can avoid alar rim overexpansion. Nasoalveolar molding should be combined with primary retrograde nasal reconstruction to prevent lower lateral cartilage relapse and to improve tip shape by removing the fibrofatty tissue that is interposed between the widely separated dome cartilages. We removed the fibrofatty tissue and approximated the dome cartilages in the midline using a retrograde approach.12 Although we routinely perform the retrograde approach without directly visualizing the lower lateral cartilages, other surgeons need to use a semiopen technique to avoid injuring the cartilage.31 Approximation of the domes in the midline produces additional columellar elongation by recruitment of nasal apex skin. It is interesting to note that Talmant et al. developed a nearly identical technique, but all molding was performed postsurgically.13 Liou et al. have also used presurgical nasoalveolar molding to treat children with bilateral cleft lip–cleft palate.32 Although Liou et al. use a different molding technique and device than that used in our group, their recent study confirms that presurgical columellar lengthening is an effective adjunctive therapy for improving nasal deformities preoperatively. Importantly, the reader should note that Liou et al. found a relative relapse in columellar length because the columella did not grow proportionately with the nasal tip.32 The reader should be cautioned when making comparisons between the findings of Liou et al. and ours because the Liou et al. study population was composed entirely of Taiwanese patients. Initial, before nasoalveolar molding, presurgical columellar measurements in our study groups 1 and 2 were compared with the mean columellar length of 3-year-old children reported 1135 Plastic and Reconstructive Surgery • October 2008 Fig. 6. Typical appearance of patients treated with nasoalveolar molding followed by primary retrograde nasal reconstruction. Secondary nasal revisions were not recommended when patients had these types of outcomes. by Farkas et al. (6.40 ⫾ 1.2 mm).30 It is important to note that the study by Farkas et al. included four different ethnic origins (Anglo-Saxon, Latin, Slavic, and Germanic); however, of the 155 facial proportions measured, only 14 showed statistically significant differences among the four groups. These included nasal tip protrusion and columellar length–to–nasal tip protrusion ratio. When differences between the Anglo-Saxon and the Latin groups were considered, only nasal tip protrusion–to–nasal height ratio was significantly different. Based on these results, we believe that the ethnic differences between our two study groups and the population studied by Farkas et al. are minor; therefore, we believe that valid conclusions can be drawn from this study. Photogrammetry was chosen to obtain the data in this study. It was proven to be reliable in studies including facial landmarks by Ferrario et al.33 and Nechala et al.,34 which compared photogrammetry with direct measurements, and showed that sharp facial profile contours could eliminate the differences between the direct and indirect measurements of the nose. The strengths and limitations of photogrammetry must be appreciated, and it is bet- 1136 ter suited to the evaluation of proportions, as the magnification factor is eliminated. The benefits of nasoalveolar molding are nonsurgical columellar elongation, definition of the nostril apertures, stretching of the intranasal lining to permit tension-free approximation of the dome cartilage in the midline, and provision of convexity to the lateral crura of the lower lateral cartilages (Fig. 6). By approximating the nostril apices, nasoalveolar molding produces additional columellar elongation by recruitment of nasal apex skin inside the nasal tip, forming a soft triangle. When Farkas studied columellar length in bilateral cleft lip– cleft palate patients treated with a variety of cleft techniques, he found that only 41.7 percent of the patients (10 of 24) had an optimal columellar length.29 In marked contrast, we demonstrate that 100 percent (13 of 13) of nasoalveolar molding–treated bilateral cleft lip– cleft palate patients had postsurgical columellar lengths that were not statistically different from agematched controls: 5.98 ⫾ 1.09 mm versus 6.35 ⫾ 0.99 mm, respectively (p ⬎ 0.05). This study demonstrates that presurgical columellar elongation with nasoalveolar molding and primary retrograde reconstruction results in a stable, consistent, Volume 122, Number 4 • Nasoalveolar Molding scarless nasal complex with near-normal columellar length (similar to McComb’s report) in one stage.35 Although Mulliken et al. have reported revision-free bilateral cleft nasal surgery without nasoalveolar molding up to 5.4 years of age, the need for secondary nasal revisions was eliminated in our nasoalveolar molding–treated group up to the age of 9 years.22 Presurgical nasoalveolar molding with primary retrograde nasal reconstruction improves the quality of the reconstructive outcome and decreases the number of surgical procedures. This reduction in the number of surgical procedures has the potential to lower the total cost of treatment over the lifetime of the patient.36 Barry H. Grayson, D.D.S. New York University Medical Center Institute of Reconstructive Plastic Surgery 560 First Avenue, TCH-169 New York, N.Y. 10022 barry.grayson@nyumc.org REFERENCES 1. Broadbent, T. R., and Woolf, R. M. Cleft lip nasal deformity. Ann. Plast. Surg. 12: 216, 1984. 2. Millard, D. R., Jr. Embryonic rationale for the primary correction of classical congenital clefts of the lip and palate. Ann. R. Coll. Surg. Engl. 76: 150, 1994. 3. Stenstrom, S. J., and Oberg, T. R. The nasal deformity in unilateral cleft lip: Some notes on its anatomic bases and secondary operative treatment. Plast. Reconstr. Surg. 28: 295, 1961. 4. Millard, D. R., Jr. Closure of bilateral cleft lip and elongation of columella by two operations in infancy. Plast. Reconstr. Surg. 47: 324, 1971. 5. Koh, K. S., and Ock, J. J. Columellar lengthening using the interdigitation of triangular flaps. Aesthetic Plast. Surg. 26: 78, 2002. 6. Noordhoff, M. S. Bilateral cleft lip reconstruction. Plast. Reconstr. 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Reconstr. Surg. 116: 1620, 2005. 32. Liou, E. J., Subramanian, M., and Chen, P. K. Progressive changes of columella length and nasal growth after nasoalveolar molding in bilateral cleft patients: A 3-year follow-up study. Plast. Reconstr. Surg. 119: 642, 2007. 33. Ferrario, V. F., Sforza, C., Serrao, G., Ciusa, V., and Dellavia, C. Growth and aging of facial soft tissues: A computerized three-dimensional mesh diagram analysis. Clin. Anat. 16: 420, 2003. 34. Nechala, P., Mahoney, J., and Farkas, L. G. Digital two-dimensional photogrammetry: A comparison of three techniques of obtaining digital photographs. Plast. Reconstr. Surg. 103: 1819, 1999. 35. McComb, H. Primary repair of the bilateral cleft lip nose: A 4-year review. Plast. Reconstr. Surg. 94: 37, 1994. 36. Pfeifer, T. M., Grayson, B. H., and Cutting, C. B. Nasoalveolar molding and gingivoperiosteoplasty versus alveolar bone graft: An outcome analysis of costs in the treatment of unilateral cleft alveolus. Cleft Palate Craniofac. J. 39: 26, 2002. 1137