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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 1  |  Page : 43-49

Evaluation of efficacy of a novel extraoral nasoalveolar molding technique with lip taping in cleft lip and palate patients


Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Mangalore, Karnataka, India

Date of Submission30-Jul-2019
Date of Acceptance08-Nov-2019
Date of Web Publication20-Jan-2020

Correspondence Address:
Dr. Sandeep Shetty
Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental College, Mangalore, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jclpca.jclpca_18_19

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  Abstract 


Objective: The purpose of the study was to evaluate the efficacy of an extraoral nasal molding device (EONMD) with lip taping in the treatment of patients with cleft lip and palate (CLP). The objectives of the study were to compare and evaluate the dimensions of cleft and alveolus, the morphology of the nostrils, and the width of the cleft lip between pre- and posttherapy. Materials and Methods: The study was conducted on seven patients with CLP which included four unilateral and three bilateral clefts. A novel EONMD along with lip taping was used for approximation of clefts. Extraoral and intraoral measurements were done pre- and post-nasoalveolar molding (NAM) therapy. Intraoral measurements included dimensions of cleft and alveolus, and extraoral measurements included the morphology of the nostrils and the width of cleft lip. Results: Intraorally, there was a reduction in intersegment distance. There was also an increase in the arch width along with the larger and smaller segment length which may be attributed to the growth in both unilateral and bilateral CLP. The measurements of the nose revealed a statistically significant increase in bialar width and increase in the columellar length and columellar width in both unilateral and bilateral CLP. The nostril attained its shape because of the nasal molding in all the cases. The lip measurement showed reductions in the cleft lip width. Conclusions: The study has quantitatively shown that the novel approach of presurgical NAM therapy with an EONMD with lip taping has significant advantages in the treatment of unilateral and bilateral CLP patients.

Keywords: Cleft lip and palate, extraoral nasal molding device, intraoral and extraoral measurements, lip taping, nasal stent, nasoalveolar molding, presurgical orthopedics


How to cite this article:
Shafeeq A K, Shetty S, Koya S, Husain A, Parveen K. Evaluation of efficacy of a novel extraoral nasoalveolar molding technique with lip taping in cleft lip and palate patients. J Cleft Lip Palate Craniofac Anomal 2020;7:43-9

How to cite this URL:
Shafeeq A K, Shetty S, Koya S, Husain A, Parveen K. Evaluation of efficacy of a novel extraoral nasoalveolar molding technique with lip taping in cleft lip and palate patients. J Cleft Lip Palate Craniofac Anomal [serial online] 2020 [cited 2020 Feb 22];7:43-9. Available from: http://www.jclpca.org/text.asp?2020/7/1/43/276195




  Introduction Top


Orofacial cleft (OFC) anomalies are the most common congenital and craniofacial anomalies. The overall prevalence of OFC is estimated to be approximately 1 in 700 live births, accounting for nearly one-half of all craniofacial anomalies.[1] The etiology of cleft lip and palate (CLP) is multifactorial and may be caused by genetic or environmental influences.[2] Management of the cleft involves a multidisciplinary approach, and an orthodontist plays an important role in its management from prenatal period to adulthood. Presurgical nasoalveolar molding (PNAM) is a technique which uses orthopedic appliances to shape the alveolus before surgical repair, and it is done during neonatal period. Presurgical neonatal nasal remodeling with an infant plate was first described by Dogliotti et al.[3] The first treatment protocol for nasoalveolar molding (NAM) was described and popularized by Grayson andMaull.[4]

The theory behind PNAM treatment is based on Matsuo's research that the nasal cartilage is still developing and is subject to repositioning within the first 6 weeks of life, and he described the first treatment protocol for PNAM.[5],[6] The purpose of these appliances is to actively mold and reposition the deformed nasal cartilage and alveolar process and also lengthen the deficient columella.[4] Conventionally, presurgical infant orthopedics is done using an intraoral appliance with stents along with lip taping. In this study design, the intraoral appliance was avoided. Rather, an extraoral nasal molding and lip taping technique was adopted to mold the lip, nose, and alveolus, and the efficacy of the novel extraoral nasal molding device (EONMD) technique was evaluated using various intraoral and extraoral measurements.


  Materials and Methods Top


The investigation was conducted on patients reporting to the Department of Orthodontics and the Craniofacial Unit associated with the Department of Orthodontics in the university between January 2016 and December 2017 after obtaining consent from the parents of the patient. The study proceeded after approval from the ethical committee.

PNAM therapy using novel EONMD technique was used on seven patients with CLP. The inclusion criteria of the study were patients below 1 year of age and patients with CLP either unilateral or bilateral. Patients with the isolated cleft lip were excluded from the study. All of the selected participants were belonging to the South Indian population. The initial evaluation is done by a multidisciplinary cleft craniofacial team. After the patient selection for the PNAM procedure, the detailed case history of the patient is taken. The dental cast for intraoral measurement, photographs, and extraoral anthropometric measurements were made. They were familiarized with the appliance and its use and care. The need for periodic follow-up was also emphasized to the benefit of the patient.

Impression (Aquasil Soft Putty/Regular Set, Dentsply) was made by holding the infant in an inverted position on the lap of the guardian, and the care was taken to prevent the tongue from falling back [Figure 1]. A special tray, followed by primary impression, was made using acrylic materials. A secondary impression [Figure 2] was made with heavy-bodied polyvinyl siloxane impression materials, and the study models were made. This procedure was done before and after NAM therapy, and these study models were used for the evaluation of intraoral changes before and after treatment.
Figure 1: Impression making

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Figure 2: Secondary impressions of unilateral and bilateral cleft lip–cleft palate

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An EONMD was fabricated which gains anchorage from the forehead of the patient [Figure 3]. The device consists of a forehead pad and a nasal stent. The forehead pad was made up of acrylic material. The nasal stent consists of an acrylic bulb and a connecting wire (0.8 mm stainless steel wire). The stent is connected to the forehead pad with the help of a retentive tag, and this retentive tag facilitates only up and down movement of the stent. The kidney-shaped acrylic bulb is covered with soft-tissue liner for patient comfort. A loop or a coil can be incorporated in the wire, which facilitates the activation of the appliance. In bilateral cleft lip cases, the appliance consists of an inverted Y-shaped wire component with two bulbs on each end for incorporating the bulbs in both the nostrils[7] [Figure 4].
Figure 3: Extraoral nasal molding device for unilateral cleft lip–cleft palate

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Figure 4: Extraoral nasal molding device for bilateral cleft lip–cleft palate

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The appliance was stabilized to the forehead with the help of adhesive tape (Dynaplast). The acrylic bulb was inserted into the nostril directing toward the collapsed columella of the patient, which gently lifts the alar dome cartilage [Figure 5]. Activation of the device was done on case-to-case basis, when the patient visited the clinic, and when it was seen that the nostrils needed more proper shape/position, activation of the loop was done by constricting the loop which in turn lifted the acrylic bulbs placed inside the nostrils.
Figure 5: Infants with the extraoral nasal molding device and lip taping

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Lip taping was done to approximate the cleft lips. The tape was applied to the noncleft side first, then pulled over and adhered to the cleft side, making an effort to bring the philtrum and columella to the midline [Figure 5]. Additional tapes were used wherever necessary to secure the horizontal tape to the cheeks. Patients' parents were explained regarding the initial discomfort with the appliance and the time required for the adjustment with the NAM appliance.[8] Importance of full-time wear of the appliance was emphasized.

After completion of the PNAM therapy, another set of intraoral casts was made, using the same technique. The photographs and extraoral anthropometric measurements were also taken. The extraoral and intraoral measurements were recorded using a digital caliper that is accurate up to 0.01 mm in the pre- and posttreatment visit.

The following measurements were performed on the intraoral casts [Table 1]: arch width, premaxillary protrusion, larger and smaller segment length, intersegment distance, and right and left cleft segment width (bilateral) [Figure 6]. Extraoral measurements [Table 2] made were the bialar width, columellar width, columellar length, and cleft lip width.
Table 1: Description of the parameters used for intraoral cast measurements

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Figure 6: Intraoral and extraoral measurements with vernier caliper. (a) Arch width, (b) premaxillary protrusion, (c) larger segment length, (d) smaller segment length, (e) intersegment distance, (f) right cleft segment width (bilateral), (g) left cleft segment width, (h) bialar width, (i) columellar width, (j) columellar length, and (k) cleft lip width

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Table 2: Description of the parameters used for extraoral measurements

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  Results Top


The PNAM technique used in this study with a novel extraoral NAM device showed changes intraorally and extraorally both statistically and clinically. The intraoral and extraoral measurements done before and after PNAM are shown in [Table 3], [Table 4], [Table 5]. The intraoral measurements [Table 3] revealed a statistically significant reduction of the intersegment distance. There was a reduction in premaxillary protrusion and cleft width on both right and left sides, but was not statistically significant. In addition, there was also an increase in the arch width along with the larger and smaller segment length in both the unilateral and bilateral cases, and these values were not statistically significant. Deviation of the premaxilla gets corrected with its retraction in bilateral cases. Hence, the right and the left cleft width can increase or decrease according to the movement of the direction of the premaxilla.
Table 3: Paired Samples Statistics - Intra oral measurements

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Table 4: Paired Samples Statistics - Extra oral measurements – Nose

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Table 5: Paired Samples Statistics - Extra oral measurements – Lip

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The measurements of the nose [Table 4] revealed a statistically significant increase in bialar width, columellar length, and columellar width in both unilateral and bilateral CLP cases. The nostril attained its shape because of the nasal molding in all the cases. [Figure 7], [Figure 8], [Figure 9] show case reports of unilateral and bilateral CLP patients treated with this novel extraoral NAM technique.{Table 4}
Figure 7: Comparison of the results before and after nasoalveolar molding photographs – frontal and submental view

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Figure 8: Comparison of the results before and after nasoalveolar molding photographs in bilateral cleft lip and palate patient – frontal and submental view

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Figure 9: Photographic evaluation of pre- and post-nasoalveolar molding comparison of lips in a unilateral cleft lip and palate case

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The measurements of lips [Table 5] revealed a statistically significant decrease in the cleft lip width in both unilateral and bilateral CLP cases. The lip segments get proximate with the use of lip tape in all the cases [Figure 7], [Figure 8], [Figure 9], [Figure 10].{Table 5}
Figure 10: PowerPoint slides for photographic evaluation of pre- and post-nasoalveolar molding comparison of lips in a bilateral cleft lip and palate case

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  Discussion Top


The PNAM technique is a controversial subject in regarding to the evidence supporting the benefits of this technique.[7] The modified EONMD used in this study consisting of an acrylic forehead pad and nasal stents without an intraoral appliance improved the dimension of the cleft and alveolus along with morphology of the nose and lips. The results evaluated on the intraoral casts revealed that PNAM therapy significantly reduced the intersegment distance in both the unilateral and bilateral cases. Protrusion of premaxilla also reduced in bilateral cases. In addition, there was also an increase in the arch width along with the larger and smaller segment length, which may be attributed to the growth. The study shows that in a bilateral case, alveolar molding is due to a combination of retraction and redirection of premaxilla along with the growth of the larger and smaller segment, and in a unilateral case, it is due to the redirection of growth of the larger and the smaller segment decreasing the intersegment distance.

Evaluation of the extraoral features revealed that PNAM therapy significantly improved nasal symmetry, columellar length, width, and the bialar width. The combination of columellar lengthening along with the correction of columellar deviation and the nostril height of the cleft side helped improve the nasal symmetry. Nostril height of the cleft side was not a parameter for evaluation, but on clinical observation found improving in all the cases. These improvements enabled the surgeon to attain a better nose morphology after the primary lip repair in the cleft child. Along with above-explained clinical benefits, we also found other advantages such as reduced appointment frequency, better compliance, reduced chairside time, better oral hygiene, ease of adjustment of appliance, and reduced rate of patient attrition.

Similar to this study, the following studies were also done, which has found to reduce the cleft severity with PNAM technique when used within 6 months of age of a child. Doruk and Kiliç[8] introduced a novel extraoral nasal molding appliance in which they included a circumferential headband supporting an actual NAM device, which consisted of a nasal stent made from a 0.8-mm stainless steel helical spring. After PNAM therapy, they found the shape of the cartilaginous septum, alar cartilage tip, medial and lateral crus, and alveolar segments to be molded to resemble the normal shape of these structures. Ashith et al.[9] did a case series to describe another novel and ingenious device, the MU hook used in lieu of the conventional PNAM technique. The MU hook was designed with the 0.7mm stainless steel wire in form of T with the loop and end of the T has an acrylic bulb extention and the entire assembly is covered with the protective sleeve. The hook is attached to the forehead using dynaplast for the upward pull. They presented five cases which used the MU hook for nasoalveolar molding. The reported that this device resulted in multiple benefits over the conventional PNAM. As it obviates the need of a plate, so it can be used in CVS infants or patients with neonatal teeth. Appointments are reduced, thus ensuring better compliance, comfort, and well-being of the parents and the patient. Monasterio et al.[10] conducted a comparative study using nasal elevator plus DynaCleft and NAM technique of Grayson in patients with complete unilateral cleft. The results showed both methods significantly reduced the cleft width and improved the nasal asymmetry.

Recently, the role of PNAM in the correction of cleft lip nasal deformity was evaluated in 23 patients with unilateral and bilateral clefts of the lip, belonging to the North Indian population, and these patients were given presurgical nasoalveolar splints at an early age, and lip repair was done after 2 months of molding.[11] The positive results of the above study considered NAM as a useful adjunct for the treatment of cleft lip nasal deformity. Thus, there are a number of studies that have been published in which the PNAM technique was used in the treatment of the patients with unilateral and bilateral CLP.

The studies by Bongaarts et al.,[12] Liou et al.,[13] Berkowitz et al.,[14] Singh et al.,[15] Garfinkle et al.,[16] Barillas et al.,[17] Pai et al.,[18] Kozelj,[19] and Singh et al.[20] on nasal symmetry found stability in the nasal changes post-NAM treatment even though slight relapse occurred in columella length because of the differential growth in the initial year, but remained stable and well afterward. NAM-treated infants attained nearly normal nasal morphology and had definite stable changes than untreated cases.

The study done by Liou et al.[13] in bilateral complete cleft lip–cleft palate infants revealed that columellar length was significantly lengthened after NAM and was further improved after primary cheiloplasty. The columella decreased in length slightly in the 1st and 2nd years postoperatively and started to increase in length slightly in the 3rd year postoperatively, whereas the rest of the nose grew significantly in height year by year. They concluded that both PNAM and primary cheiloplasty lengthened the columella in bilateral cleft lip–cleft palate patients. However, there was a relative relapse in columella length because of the differential growth between the columella and the rest of the nose in the 1st and 2nd years postoperatively.


  Conclusions Top


The PNAM therapy using this novel approach has significant advantages in the treatment of bilateral/unilateral CLP patients. As a result, the changes associated with PNAM therapy help decrease the complexity of subsequent surgeries. It also reduces the amount of scar tissue formation postsurgery due to the approximation of the lip and alveolus by NAM therapy.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Ahmed MK, Bui AH, Taioli E. Epidemiology of cleft lip and palate. InDesigning Strategies for Cleft Lip and Palate Care 2017.  Back to cited text no. 1
    
2.
Sandberg DJ, Magee WP Jr., Denk MJ. Neonatal cleft lip and cleft palate repair. AORN J 2002;75:490-8.  Back to cited text no. 2
    
3.
Dogliotti PL, Bennun RD, Losoviz E, Ganiewich E. Non-surgical treatment of nasal deformity in a patient with a fractured/Non-surgical treatment of nasal deformity in the cleft patient. Rev Ateneo Arg Odontol 1991;27:31-5.  Back to cited text no. 3
    
4.
Grayson BH, Maull D. Nasoalveolar molding for infants born with clefts of the lip, alveolus, and palate. Clin Plast Surg 2004;31:149-58, vii.  Back to cited text no. 4
    
5.
Matsuo K, Hirose T. Preoperative non-surgical over-correction of cleft lip nasal deformity. Br J Plast Surg 1991;44:5-11.  Back to cited text no. 5
    
6.
Grayson BH, Santiago PE, Brecht LE, Cutting CB. Presurgical nasoalveolar molding in infants with cleft lip and palate. Cleft Palate Craniofac J 1999;36:486-98.  Back to cited text no. 6
    
7.
Grayson BH, Shetye PR. Presurgical nasoalveolar moulding treatment in cleft lip and palate patients. Indian journal of plastic surgery: Official publication of the Association of Plastic Surgeons of India. 2009;42(Suppl):S56.  Back to cited text no. 7
    
8.
Doruk C, Kiliç B. Extraoral nasal molding in a newborn with unilateral cleft lip and palate: A case report. Cleft Palate Craniofac J 2005;42:699-702.  Back to cited text no. 8
    
9.
Ashith MV, Roy P, Mangal U, Mithwik, Philip N. MU hook simplifying PNAM. J Contemp Orthod 2017;1:52-5.  Back to cited text no. 9
    
10.
Monasterio L, Ford A, Gutiérrez C, Tastets ME, García J. Comparative study of nasoalveolar molding methods: Nasal elevator plus DynaCleft® versus NAM-Grayson in patients with complete unilateral cleft lip and palate. Cleft Palate Craniofac J 2013;50:548-54.  Back to cited text no. 10
    
11.
Mishra B, Singh AK, Zaidi J, Singh GK, Agrawal R, Kumar V. Presurgical nasoalveolar molding for correction of cleft lip nasal deformity: Experience from Northern India. Eplasty 2010;10. pii: e55.  Back to cited text no. 11
    
12.
Bongaarts CA, Kuijpers-Jagtman AM, van 't Hof MA, Prahl-Andersen B. The effect of infant orthopedics on the occlusion of the deciduous dentition in children with complete unilateral cleft lip and palate (Dutchcleft). Cleft Palate Craniofac J 2004;41:633-41.  Back to cited text no. 12
    
13.
Liou EJ, Subramanian M, Chen PK, Huang CS. The progressive changes of nasal symmetry and growth after nasoalveolar molding: A three-year follow-up study. Plast Reconstr Surg 2004;114:858-64.  Back to cited text no. 13
    
14.
Berkowitz S, Mejia M, Bystrik A. A comparison of the effects of the Latham-Millard procedure with those of a conservative treatment approach for dental occlusion and facial aesthetics in unilateral and bilateral complete cleft lip and palate: Part I. Dental occlusion. Plast Reconstr Surg 2004;113:1-8.  Back to cited text no. 14
    
15.
Singh GD, Levy-Bercowski D, Santiago PE. Three-dimensional nasal changes following nasoalveolar molding in patients with unilateral cleft lip and palate: Geometric morphometrics. Cleft Palate Craniofac J 2005;42:403-9.  Back to cited text no. 15
    
16.
Garfinkle JS, King TW, Grayson BH, Brecht LE, Cutting CB. A 12-year anthropometric evaluation of the nose in bilateral cleft lip-cleft palate patients following nasoalveolar molding and cutting bilateral cleft lip and nose reconstruction. Plast Reconstr Surg 2011;127:1659-67.  Back to cited text no. 16
    
17.
Barillas I, Dec W, Warren SM, Cutting CB, Grayson BH. Nasoalveolar molding improves long-term nasal symmetry in complete unilateral cleft lip-cleft palate patients. Plast Reconstr Surg 2009;123:1002-6.  Back to cited text no. 17
    
18.
Pai BC, Ko EW, Huang CS, Liou EJ. Symmetry of the nose after presurgical nasoalveolar molding in infants with unilateral cleft lip and palate: A preliminary study. Cleft Palate Craniofac J 2005;42:658-63.  Back to cited text no. 18
    
19.
Kozelj V. Experience with presurgical nasal molding in infants with cleft lip and nose deformity. Plast Reconstr Surg 2007;120:738-45.  Back to cited text no. 19
    
20.
Singh GD, Levy-Bercowski D, Yáñez MA, Santiago PE. Three-dimensional facial morphology following surgical repair of unilateral cleft lip and palate in patients after nasoalveolar molding. Orthod Craniofac Res 2007;10:161-6.  Back to cited text no. 20
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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