Three-Dimensional Nasal Changes Following ... - SAGE Journals

Three-Dimensional Nasal Changes Following Nasoalveolar Molding in Patients With Unilateral Cleft Lip and Palate: Geometric Morphometrics G. DAVE SINGH, D.D.SC., PH.D., B.D.S. DANIEL LEVY-BERCOWSKI, D.D.S. PEDRO E. SANTIAGO, D.M.D. Objective: To evaluate three-dimensional changes in nasal morphology in patients with unilateral cleft lip and palate treated with presurgical nasoalveolar molding (NAM) to correct naso-labio-alveolar deformity. Design: This was a prospective, longitudinal study. Digital stereophotogrammetry was used to capture three-dimensional facial images, and x, y, and z coordinates of 28 nasal landmarks were digitized. Sample: Ten patients with unilateral cleft lip and palate. Main Outcome Measures: Nasal form changes between T1 (age: 28 6 2 days, pre-NAM) and T2 (age: 140 6 2 days, post-NAM), using conventional measurements and finite-element scaling analysis. Results: Overall nasal changes were statistically different (p , .01), but no linear or curvilinear changes were found. Specifically, relative size increases were found on the noncleft side, involving the upper nose (30%), alar depth (20%), alar dome (30%), columella height (30%), and lateral wall of the nostril (17%). On the cleft side, the following showed a size increase: upper nose (8%), alar dome (5%), columella height (30%), and lateral wall of the nostril (30%). The cleft-side alar curvature, however, showed a large decrease in size (80%), but no changes on the noncleft side were found. Corresponding shape changes and angular changes were also found. Conclusions: Using NAM, bilateral nasal symmetry in patients with unilateral cleft lip and palate was improved before surgical repair. Furthermore, slight overcorrection of the alar dome on the cleft side using pressure exerted by the nasal stent is indicated to maintain the NAM result. KEY WORDS: cleft lip/palate, geometric morphometrics, growth guidance, nasoalveolar molding

In patients with unilateral cleft lip/palate (UCLP), the nasolabial defect influences the physical appearance of the child and may impair psychosocial development. Therefore, correction of the nasal deformity associated with UCLP is an integral part of primary cleft lip repair (Salyer, 1992). Huffman and Lierle (1949) described nasal deformity associated with UCLP, which included dysmorphology of the columella, nasal tip, alar cartilage, and nasal sill. In addition, several internal nasal deformities may contribute to nasal obstruction, including imbalance of the facial musculature, as well as hypoplasia and

asymmetry of the skeletal nasal base (Bardach and Cutting, 1990). Although Wetmore (1992) emphasized the importance of maintaining normal nasal function in the cleft palate patient, residual deformities after surgery for UCLP include nostril floor asymmetry, columella length asymmetry, a flat nasal bridge, a wide soft-tissue nose, a flat nasal tip, and deficient nasal tip protrusion (Farkas et al., 1993). To reduce residual nasal deformities, Matsuo et al. (1989) described presurgical molding of the cleft nasal cartilage in the neonate. The high degree of plasticity of the nasal cartilage in the neonatal period is believed to be caused by high levels of hyaluronan, a component of the proteoglycan extracellular matrix (e.g., Singh et al., 1994) found circulating in the infant for several weeks after birth. In view of these properties, following the principles of presurgical orthopedics described by McNeil (1950), Dogliotti et al. (1991) and Grayson et al. (1993) both designed molding plates in combination with a nasal stent to help mold the nose as well as the cleft alveolar segments. The current nasoalveolar molding (NAM) protocol for cleft patients has been described by Grayson et al. (1993), Grayson and Santiago (1997), Cutting et al. (1998), Bennun et al. (1999), and Grayson and Cutting (2001). This treatment modality in-

Dr. Singh is an Associate Professor, Center for Craniofacial Disorders and School of Medicine, Dr. Levy-Bercowski is an Orthodontic Resident, School of Dentistry, and Dr. Santiago is a Professor and Director, Center for Craniofacial Disorders and School of Dentistry Research Center, University of Puerto Rico, San Juan, Puerto Rico. This study was funded in part by NIH Grant # G12 RR 03051 (GDS) and by the Rostro Foundation (Puerto Rico). Submitted May 2004; Accepted July 2004. Address correspondence to: G.D. Singh, D.D.Sc., Ph.D., B.D.S., Center for Craniofacial Disorders, Office A-570, School of Medicine, University of Puerto Rico, P.O. Box 365067, San Juan, Puerto Rico 00936-5067. E-mail [email protected]. 403

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Cleft Palate–Craniofacial Journal, July 2005, Vol. 42 No. 4

FIGURE 1 Definitions of the 28 soft tissue nasal landmarks employed in the study. Stn 5 soft tissue nasion; prn 5 pronasale; acr 5 right alar curvature; pacr 5 right posterior alar curvature; uacr 5 right upper alar curvature; rhinion (ro) 5 midpoint between stn and prn; uacl 5 left superior alar curvature; pacl 5 left posterior alar curvature; acl 5 left alar curvature; alr 5 right alar; adr 5 right alar (deep); almr 5 midpoint between alr and adr; admr 5 midpoint between adr and prn; adl 5 left alar (deep); adml 5 midpoint between adr and prn; all 5 left alar; alml 5 midpoint between all and adl; sball 5 left subalare; nll 5 left nostril (lateral); c9l 5 left columella; cml 5 middle left columella; sn9l 5 insertion of the columella base on the left side of the nose; sn9r 5 insertion of the columellar base on the right side of the nose; sn 5 subnasale; cmr 5 middle right columella; c9r 5 right columella; nlr 5 right nostril (lateral); sbalr 5 right subalare.

cludes in its objectives the active molding and repositioning of the deformed nasal cartilages and alveolar processes (Li et al., 2002), as well as the lengthening of the deficient columella. For the assessment of nasal form-change, several morphometric techniques are available, each having its individual advantages and disadvantages (Marcus and Corti, 1996). One advantage of finite-element scaling analysis (FESA) is that it is able to provide graphical representations of form change. Thus, to quantify soft-tissue nasal changes in patients treated with the NAM appliance for the correction of UCLP, new three-dimensional (3D) software (MorphoStudio, www.orthovisage.com) that is similar to that used in previous two-dimensional studies (Singh and Thind, 2003; Singh et al., 2004) was employed. The aim of this study was to test the null hypothesis that there are no changes in 3D nasal morphology in patients with unilateral cleft lip and palate treated with NAM before surgical correction. Rejection of the null hypothesis was based on the quantification and localization of form-changes, which may indicate whether NAM facial growth guidance simulates the vectors associated with normal nasal development. MATERIALS

AND

METHODS

Sample In this preliminary study, the sample consisted of 10 patients (six male and four female) with UCLP who attended the Cen-

ter for Craniofacial Disorders, Puerto Rico. The average age at the beginning of the treatment (T1) was 28 6 2 days. Before treatment, informed consent and institutional review board approval were obtained, and all identities were kept anonymous throughout. Exclusion criteria for the sample were a history of presurgical orthopedic treatment or oral surgery, facial trauma requiring hospital attendance, any other congenital maxillofacial deformity, age .5 weeks old, or unwillingness to cooperate in the study. Collection of 3D Landmark Data This study used 3D digital stereophotogrammetry. The 3D stereophotograms were captured using a DSP-400 image acquisition unit (3dMD LLC, Atlanta, GA). Subjects were positioned 90 cm in front of the unit for image acquisition in a room with adequate ambient lighting. The acquisition or capture time for the 3D image was 2 milliseconds. In this time, four geometric images and two texture images were captured with the patient at rest. The processing time to convert these data into a viewable 3D image was about 4 to 5 seconds, using a 733-mHz processor. We repeated the data collection procedure three times for each individual, as this only took a few minutes. A single operator digitized 28 landmarks in the soft tissue nasal area (Fig. 1), using appropriate software. The reproducibility of landmark identification, and reliability of the

Singh et al., 3D NASAL CHANGES FOLLOWING NASOALVEOLAR MOLDING

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TABLE 1 Linear Analysis of Mean Lengths (mm)* T1

stn-sn stn-prn sn-prn sbalr-sn9r sball-sn9l alr-all acr-acl sbalr-sball sn-c9r sn-c9l acr-prn acl-prn

20.97 14.47 7.86 4.27 10.33 25.17 26.70 18.94 5.32 7.28 19.65 21.78

6 6 6 6 6 6 6 6 6 6 6 6

T2

2.2 1.8 0.9 1.1 3.3 3.2 2.8 2.9 0.7 3.3 5.2 4.1

22.01 15.68 8.13 5.05 8.06 23.91 26.10 16.95 5.91 6.09 20.86 21.64

6 6 6 6 6 6 6 6 6 6 6 6

p

1.8 2.1 1.4 0.7 1.9 2.1 1.6 2.4 0.91 1.1 3.8 3.13

.26 .20 .64 .07 .07 .35 .63 .12 .13 .30 .56 .93

* T1 5 pretreatment; T2 5 posttreatment. See Figure 1 legend for key to landmarks

FIGURE 2 The NAM appliance employed in the study, consisting of a molding plate used to approximate the minor and major palatal segments, a stent for nasal molding, and a button for tape attachment.

x, y, and z data collection procedure was tested by triplicate digitization. Nasoalveolar Molding Before treatment, intraoral impressions were taken using polyvinylsiloxane for the construction of the NAM molding plate. Once fabricated (Fig. 2), the molding plate was inserted and used to approximate the minor and major palatal segments. The NAM appliance was adjusted on a weekly basis by trimming or adding acrylic to specific areas on the fitting surface to allow the controlled repositioning of the palatal segments. Once the segments were approximated, the nasal stent wire was added to the plate (Fig. 2) to start the nasal molding, following the protocol that we have been employing since the late 1990s. The nasal stent was activated by adding hard and soft acrylic or by bending the nasal stent wire. For analysis, linear and curvilinear distances as well as an-

gular measures were undertaken, using t tests for statistical significance. In addition, FESA of Procrustes means (Singh and Thind, 2003; Singh et al., 2004) of the nasal configurations was performed, using the MorphoStudio software. RESULTS Patient acceptance and compliance with NAM was found to be excellent (Fig. 3a through 3c). Posttreatment (T2), the average age of the sample was 140 6 2 days. The reproducibility of landmark identification and the reliability of the x, y, and z data collection procedure tested by triplicate digitization was found to be consistent (p . .05). Linear Measurements Despite the clinical changes observed (Figs. 3a through 3c), linear caliper lengths did not show any statistically significant changes when T1 and T2 parameters were compared. However, curvilinear analysis showed that nostril width was greater on the cleft side before treatment and, despite its reduction during treatment, remained wider posttreatment than that on the noncleft side (Tables 1 and 2). In contrast, columellar and alar lengths did not appear to differ before or after treatment with NAM.

FIGURE 3 Observed clinical results. a: Pretreatment nasal deformity and asymmetry affecting the nostril and columella; b: Posttreatment appearance after using the NAM appliance, showing reduced nasal deformity with decreased nasal width and increased nasal symmetry affecting the nostril and columella; c: Posttreatment views to show improved nasal projection, associated with columellar lengthening after using the NAM appliance.

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TABLE 2 Curvilinear Lengths (mm)* T2

T1

Nostril width Columella Alar length

Noncleft

Cleft

p

Noncleft

Cleft

p

4.65 6 1.0 5.05 6 0.6 24.12 6 3.1

9.81 6 4.2 7.87 6 4.2 25.12 6 3.1

.01 N.S. N.S.

4.88 6 0.7 5.52 6 0.9 26.61 6 3.2

7.35 6 1.9 5.53 6 0.9 24.68 6 2.3

.02 N.S. N.S.

* T1 5 pretreament; T2 5 posttreatment.

Angular Measurements

cml) increased in height by 30%, but the noncleft side (snsn9r-cmr) increased by only 10%.

Comparison at T1 and T2 showed a reduction in angles, representing a narrowing of the nostril on the cleft side (Table 3 and Fig. 1). Specifically, a reduction of 148 (p , .05) in angle sn-prn-all on the cleft side was revealed, consistent with decreased nasal width. Concomitantly, an increased anteroposterior nasal projection by 7 to 148 (p , .01) was found at angles prn-stn-sn and sn-prn-stn, which showed significant decreases when T1 and T2 configurations were compared (Table 3). There also was a diminution in alar concavity on the cleft side by T2, as indicated by angle sn-prn-adl. Similarly, angles that represented the lateral aspect of both nostrils (sn-prn-sball and sn-prn-sbalr) were significantly decreased on the cleft and noncleft sides (Table 3). Finite-Element Scaling Analysis Size Change The upper nose (stn-prn-uacl) showed a relative increase in size (8%) on the cleft side and a 30% increase on the noncleft side (stn-prn-uacr; Fig. 4). The alar curvature (acl-all-pacl) on the cleft side showed a decrease in size of 15%, whereas on the non-cleft side (acr-alr-pacr) there were no changes. Alar concavity on the noncleft side (prn-c9r-cmr) increased in size by 20%, but on the cleft side there were no changes. For the lateral wall of the nostril, the cleft side (sball-nll) increased in size by 40% and the noncleft side (sbalr-nlr) increased by 17%. The alar dome on the noncleft side (prn-adr-c9r-cmr) increased in size by 30%, but the cleft side (prn-c9l-adl-cml) showed only a 5% increase. The columella on the cleft side (sn-sn9lTABLE 3 Angular Measurements* Angle

acr-sn-prn acl-sn-prn sn-prn-acl sn-prn-acr sn-prn-alr sn-prn-all sn-prn-adr sn-prn-adl sn-prn-sbalr sn-prn-sball pm-stn-sn sn-prn-stn

T1

106.6 80.26 75.9 42.8 57.9 80.9 68.4 81.7 45.9 73.3 15.3 134.1

6 6 6 6 6 6 6 6 6 6 6 6

T2

18.2 19.8 20.44 10.9 12.8 17.1 12.6 16.8 11.3 20.5 4.8 12.6

* T1 5 pretreatment; T2 5 posttreatment.

98.2 84.0 63.2 45.6 53.6 67.2 62.2 69.6 41.6 55.9 22.1 119.5

6 6 6 6 6 6 6 6 6 6 6 6

p

11.3 6.1 5.1 10.3 5.3 3.5 5.1 6.7 6.6 5.9 3.0 6.6

N.S. N.S. N.S. N.S. N.S. .02 N.S. .05 .0002 .02 .001 .01

Shape Change For shape change (Fig. 5), the upper nose showed no change on the noncleft side (green coloration), whereas the cleft side (stn-prn-uacl) showed increased shape change (orange coloration). The alar curvature (acl-all-pacl) on the cleft side showed a marked shape change (magenta coloration) compared with the noncleft side (acr-alr-pacr) (yellow coloration). Alar concavity on the cleft side showed less shape change compared with the noncleft side (prn-snr-cr-almr-adr) (orangered coloration). For the lateral wall of the nostril, the cleft side (sball-nll) showed marked shape change (red coloration) compared with the noncleft side. In contrast, the alar dome on the noncleft side (prn-c9l-adl-cml) showed less shape change compared with the cleft side (magenta coloration). The columella (sn-sn9l-cml) on the cleft side showed increased shape change (red coloration) when compared with the noncleft side. Overall, these results indicate that bilateral nasal symmetry is improved by using NAM in patients with UCLP before surgical repair. DISCUSSION As part of our treatment protocol, NAM is used to approximate the alveolar segments to perform a gingivoperioplasty procedure during the primary surgery. Similarly, NAM permits the lip segments to be placed in a more anatomically correct position to facilitate lip repair under minimal tension, so that healing and scarring can be minimized. In addition, NAM is used to correct the nasal deformity so that a one-stage primary lip, nose, and alveolar repair can be performed. Although it is thought that the provision of NAM results in better treatment outcomes (Maull et al., 1999), it remains necessary to localize and quantify the nasal changes using a noninvasive 3D analysis. However, relatively small numbers of babies are born with orofacial clefts, and even fewer infants participate in clinical studies, so insufficient numbers of children may be available for traditional analyses. In this study a power calculation for sample size was undertaken. At level .05 of probability and a desired power of 80%, a sample size of 56 was indicated. Clearly this sample size is currently untenable given the constraints outlined above. However, Rohlf (1999) has developed software (tpsPower) that relates k landmarks in d dimensions to provide an


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FIGURE 4 Finite-element scaling analysis to show size change. The figure on the left shows the size changes mapped into the mean pretreatment nasal configuration, whereas the figure on the right shows the same changes mapped into the mean posttreatment nasal configuration.

appropriate n sample size. Using the landmark data, tpsPower indicated that with n 5 10 in each sample and with standard deviations derived from the mean procrustean forms, the null hypothesis of no difference in the means would almost always be rejected. This result was computed using Goodall’s F test, which makes very strict assumptions (e.g., independent isotropic error at all landmarks). Therefore, a minimum sample size of n 5 10 was deemed sufficient for statistical analysis using geometric morphometrics in this study. The field of facial soft tissue analysis has not established reliable, valid 3D imaging methods for very young patients (Farkas et al., 1992), as it is impossible for a very young subject to remain in the same position for even a few seconds. Thus, a 3D imaging system must have a very fast speed of capture and the ability to image a patient from multiple view points in one simultaneous capture, as accuracy is compromised when ‘‘stitching’’ 3D images together. In this regard, the surface stereophotogrammetry employed in this study

FIGURE 5 Finite-element scaling analysis to show shape change.

(DSP400, 3dMD, LLC) projects a random light pattern on to the subject and captures an entire facial area in 0.002 seconds, using synchronized digital cameras set at various angles in an optimum configuration. The 3D surface geometry and texture of the patient are acquired simultaneously, and sophisticated algorithms are used to generate an accurate 3D image. Thus, the main advantage of using 3D digital stereophotogrammetry is that data capture is a noninvasive, nonionizing, ‘‘no touch’’ technique. The other benefits are its validated accuracy, with a mean distance error of 0.04 mm and a RMS of 0.36 mm (Smith, 1999), and its submillimeter accuracy (Otto, 2000). Grayson et al. (1999) described the nasal deformity associated with UCLP. At a muscular level, interruption of the orbicularis oris affects nasal morphology by displacing the insertion of the columella toward the noncleft side and the nasal tip to the opposite side. Other factors associated with UCLP nasal deformity include hypoplasia of the lesser segment as

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well as a deficiency of maxillary bone (Bardach and Cutting, 1990). McCarthy (1990) suggested that these factors accentuate the nasal deformity because the alar base insertion on the cleft side does not have any support, increasing the asymmetry of the cartilages and the tip of the nose. While lateral extension of the alar base produces flattening and elongation of the ala, NAM of the alveolar segments compensates for the lack of bone at the alar base insertion once the segments are united (Grayson et al., 1999). Furthermore, gingivoperioplasty results in the formation of a bony bridge in 60% of cases (Santiago et al., 1998). Ferrario et al. (1997) studied the morphometry of normal nasal growth using a 3D analysis, while Grayson and Santiago (1997) and Grayson et al. (1999) described the NAM technique and reported the changes that take place in the cleft nasal region based on observations of treated cases. Maull et al. (1999) employed plaster models of the nasal region to determine the effects of the nasoalveolar molding and the indices of symmetry. Similarly, Russell et al. (2001) used plaster models of the nasal region and employed video images to study the nasal morphology. In this study, 28 landmarks (Burke, 1989; Farkas et al., 1992) were employed to provide detailed information on morphologic nasal changes. To date, there are no known reports in the literature that describe the quantitative, therapeutic effects of NAM in the correction of the nasal deformity using 3D stereophotogrammetry. Growth disturbance has not been reported until now; most authors report the primary nasal correction and recommend its simultaneous repair with the lip. Using NAM, forces are exerted on the nasal structures, when approximating the alveolar segments, that permit straightening of the columella and correction of alar cartilage displacement. The nasal stent produces pressure on the alar domes. Recently, Grayson and Cutting (2001) comprehensively reviewed the use of NAM in primary correction of the unilateral cleft nose. Earlier, Grayson et al. (1999) noted that the NAM technique is associated with a decreased need for surgical columella reconstruction. Similarly, Maull et al. (1999) used a retrospective design on nasal casts of cleft subjects to obtain a numerical asymmetry score. Both studies concluded that NAM significantly increases the symmetry of the nose. In this investigation, traditional and geometric morphometrics of nasal landmark data obtained from 3D images were employed without taking potentially distorting impressions. The results indicate that there was a reduction in the deviation of columella (sn-prn) in relation to its insertion by 148 after treatment with NAM (Fig. 3c). Although the columella became more medially positioned after NAM, the bilateral symmetry of the alar cartilages also improved by about 108 when both sides are compared at T1 and T2 (Fig. 3a and 3c). These changes also improve nasal projection (Fig. 3b). Grayson and Cutting (2001) suggested that NAM in infants has aims that go beyond the traditional goals of presurgical orthopedics. These aims include improvement of long-term nasal esthetics, reduction in number of nasal surgical procedures, reduced need for secondary bone grafts in the majority of pa-

tients if gingivoperiosteoplasty is included in the protocol, no greater growth disturbance than is found in cleft patients undergoing good traditional treatments, and savings in cost to the patient and society through the reduction in number of surgical hospital admissions. In accord with the chondral-modeling hypothesis (Hamrick, 1999), this study indicates that NAM may be acting as an inductive mechanism that stimulates the activity of immature nasal chondroblasts, producing an interstitial expansion that is associated with improvements in nasal morphology. However, further investigations are needed to determine the final nasal morphology after the cessation of growth (Farmand, 2002) and to establish whether NAM before any surgical corrections provides improved clinical outcomes in the long term that simulate a noncleft nasal morphology. Acknowledgments. We thank Miguel A. Yan˜ez, M.D., and Enrique Pasarell, M.D., for providing the patients who participated in this investigation.

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