|Year : 2014 | Volume
| Issue : 1 | Page : 36-47
Nasoalveolar molding treatment in presurgical infant orthopedics in cleft lip and cleft palate patients
N. Retnakumari1, S. Divya2, S. Meenakumari3, P. S. Ajith4
1 Professor and Head of Pedodontics, Government Dental College, Kozhikode, Kerala, India
2 Post Graduate Student of Pedodontics, Government Dental College, Kozhikode, Kerala, India
3 Assistant Surgeon (Pediatrician) Taluk Hospital, Ambalappuzha, Alleppey, Kerala, India
4 Consultant Surgeon (Plastic Surgery), General Hospital, Changanassery, Kottayam, India
|Date of Web Publication||4-Jun-2014|
Professor and Head of Pedodontics, Government Dental College, Kozhikode, Kerala-673008
Source of Support: None, Conflict of Interest: None
The nasoalveolar molding (NAM) technique is a new approach to presurgical infant orthopedics that reduces the severity of the initial cleft alveolar and nasal deformity. This technique facilitates the primary surgical repair of the nose and lip to heal under minimal tension, thereby reducing scar formation and improving the esthetic result. NAM technique is the nonsurgical, passive method of bringing the gum and lip together by redirecting the forces of natural growth. NAM has proved to be an effective adjunctive therapy for reducing hard and soft tissue cleft deformity before surgery. This paper reviews the basic principles of NAM therapy, various types of appliances used in this therapy, protocol followed, and a critical evaluation of the advantages and disadvantages of this technique. Universally authors have agreed the positive outcome of NAM for better esthetics after cleft lip and palate (CLP) repair, but the long-term effects of this therapy are yet to be substantiated. Despite a relative paucity of high-level evidence, NAM appears to be a promising technique that deserves further research.
Keywords: Cleft lip and cleft palate, nasoalveolar molding, NAM protocol, NAM appliances, presurgical infant orthopedics
|How to cite this article:|
Retnakumari N, Divya S, Meenakumari S, Ajith PS. Nasoalveolar molding treatment in presurgical infant orthopedics in cleft lip and cleft palate patients. Arch Med Health Sci 2014;2:36-47
|How to cite this URL:|
Retnakumari N, Divya S, Meenakumari S, Ajith PS. Nasoalveolar molding treatment in presurgical infant orthopedics in cleft lip and cleft palate patients. Arch Med Health Sci [serial online] 2014 [cited 2017 Oct 20];2:36-47. Available from: http://www.amhsjournal.org/text.asp?2014/2/1/36/133804
| Introduction|| |
Cleft lip and palate (CLP) are among the most common types of birth defects. Two-thirds of all cases of clefting involve the lip with or without involvement of the palate; whereas, one-third of all cases occur as an isolated deformity of the palate. Males predominate within the CLP group (60-80% of cases); whereas, females constitute the majority within the cleft palate (CP) group. CLP deformity is strongly associated with bilateral cleft lips (CLs) (86% of cases); the association decreases to 68% with unilateral CL. The left side is most commonly involved in unilateral CL cases. Interracial differences exist in the incidence of CLP versus CP. The mean incidence of CLP is 2.1 cases per 1,000 live births among Asians, one case per 1,000 live births among white people, and 0.41 cases per 1,000 live births among black people. A high incidence of the CLP is seen in North American populations of Asian descent, such as Indians of the southwestern United States and the west coast of Canada. 
CLP along with nasal deformity is one of the common anomalies occurring during the embryonic development of face. By the end of the 4 th week in gestational period of human embryo, bilateral swellings and nasal placodes develop on the lower part of the frontonasal prominence. The medial and lateral nasal prominences develop as peripheral thickenings of the mesenchymal tissue of the nasal placodes, producing two central depressions, and the nasal pits. Failure of the nose to develop completely is associated with failure of the nasal placodes to develop. Between the 4 th and 8 th weeks, the paired medial nasal prominences fuse with each other, with the paired lateral nasal prominences, and with cells in the maxillary prominences. Successful fusion of the medial nasal and maxillary prominences is essential for continuity of the upper lip and primary palate. Failure of fusion of one or both medial nasal and maxillary prominences results in unilateral or bilateral CL, respectively.
As the face nears the completion of the "developmental critical period", from approximately the end of the 6 th -8 th intrauterine week, the lateral palatine processes grow out from the walls of the still common oronasal cavity. Growth of these paired processes is initially medial, but continues inferolaterally to lie on either side of the developing tongue. Nearing the 8 th week, palatal shelf elevation begins while the tongue is depressed downward and forward. Once in contact, epithelial cells of the palatal shelves degenerate by programmed cell death uniting the paired processes in a process known as fusion. Once fusion of the shelves of the secondary palate occurs, the mesenchymal cells differentiate, and become osteogenic cells contributing to the bony development of the premaxillary, maxillary, and palatine portions of the palate. CP results from the failure of fusion of these paired lateral palatine processes as a result of a defect in any of the three major stages of palatal formation - palatal shelf outgrowth, elevation, or fusion.
Unilateral complete clefts are characterized by disruption of the lip, nostril sill, and alveolus (complete primary palate). The deformities seen in relation to CL in these cases are cupids bow more or less clearly defined, philtral ridge is ill-defined if not absent, abnormal shortness of the lip compared with its height on the normal side, fernum of the vermilion is often hypertrophied, depth of vestibular sulcus can be outlined only on noncleft side, the cutaneous portion of the lip is often convex in both vertical and horizontal directions as the underlying muscles which have lost their medial insertion tend to draw up into ball of fibers. Nasal deformities associated are flattening and widening of the nostril aperture on cleft side, the columella is slanted towards the affected side, the alar base is slightly everted, the anterior nasal spine deviated towards normal side, and tip of the nose is slightly asymmetrical.
In bilateral CLP cases, the cupid's bow is generally absent and the cutaneous portion often appears as a convex surface shaped like a lens. There is no trace of philtral ridge and the prolabium is usually devoid of properly developed muscle fibers. The nasal deformities seen are nasal tip flattened and widened, the columella seems too short, and septal cartilage is often underdeveloped.  The most obvious aspect of a complete bilateral cleft is the protruding premaxilla. Because of the lack of connection of the premaxilla with the lateral palatal shelves, the premaxilla has not been "reined back" into alignment with the lateral arch segments during fetal development. At the time of birth, the premaxilla protrudes on a vomerine stem. Uncontrolled growth at the premaxillary suture results in overprojection of the premaxilla, with or without rotation, and angulation of the segment. Just as the premaxilla is not reined back by the lateral palatal shelves, the lateral palatal shelves are not pulled forward by their attachment to the premaxilla. Without the intervening premaxilla to maintain arch width, the lateral palatal shelves collapse toward the midline. The severity of this disruption of arch morphology varies and will dictate the tension on the repair, the degree of dissection required, and ultimately, the final esthetic result unless it is corrected with presurgical orthopedics. 
The traditional treatment of CLP involves multiple surgeries.  The surgical treatment of CLP has been documented since AD 317, when Chinese general Wei Yang-Chi had his CL corrected by cutting and stitching the edges together. As surgical techniques advanced from the 1800s to 1900s, the focus shifted to achieving precise muscle closure, delicate technique, and a better esthetic result.
The concept of presurgical orthopedic cleft molding was developed to further improve the esthetic result of lip repair. Use of presurgical orthopedics is recorded as early as the 18 th century. The auricular cartilage could be molded with permanent results if treatment was started within 6 weeks of life. During this period there are high levels of maternal estrogen in the fetal circulation which triggers an increase in the hyaluronic acid. Hyaluronic acid alters the cartilage, ligament, and connective tissue elasticity by breaking down intercellular matrix. Levels of estrogen start dropping at 6 weeks of age. Matsuo applied this concept for the correction of nasal deformities in CL patients. It is on this principle that the concept of nasoalveolar molding (NAM) works. It is also suggested that NAM stimulated immature nasal chondroblasts, producing an interstitial expansion that is associated with improvement in the nasal morphology (Chondral Modeling Hypothesis, Hamrick 1999).  Grayson and Shetye developed the concept of NAM, which combined a nasal molding stent with a passive, presurgical molding appliance in treating CLP infants. 
| Terminology|| |
In presurgical orthopedic therapy, orthodontic techniques are used to mold the maxillary, alveolar, and nasal tissues of an infant with a unilateral or bilateral CLP. Other terms used for these techniques are neonatal infant orthopedics, presurgical infant orthopedics, and nasal-alveolar molding. Because the infant does not yet have teeth, the term orthodontics would be inaccurate; thus, orthopedics is the preferred term. Presurgical orthopedic devices are a controversial topic in cleft treatment. With increasing clinical experience, the long-term outcome and the specific role of presurgical orthopedics are becoming better defined. ,
| What is NAM?|| |
NAM is the nonsurgical, passive method of bringing the gum and lip together by redirecting the forces of natural growth. It is nonpainful and easy to use. It also allows for correction of the flattened nose prior to surgery and facilitates nose repair at the time of lip repair. 
Presurgical NAM works on the principle of 'negative sculpturing' and 'passive molding' of the alveolus and adjacent soft tissues. In passive molding, a custom-made molding plate of acrylic is used to gently direct the growth of the alveolus to get the desired result later on. While in negative sculpturing serial modifications are made to the internal surfaces of the molding appliance with addition or deletion of material in certain areas to get desired shape of the alveolus and nose. 
Objectives of NAM technique
- Principal objective of presurgical NAM is to reduce the severity of the initial cleft deformity which is achieved by active molding and repositioning of the deformed nasal cartilages and alveolar processes. ,,
- Nonsurgical lengthening of the columella. ,,
- Approximation of lip segments to reduce tension in the tissues after lip repair and thus reduce scarring. ,
- Presurgical NAM is recommended to produce more favorable bone formation by reducing the size of the cleft and improving nasal esthetics. ,
- Reduces the need for secondary alveolar bone grafts. ,
The critical factors for evaluating unilateral complete clefts are the position of the lesser and greater alveolar segments, the vertical height of the lateral lip element, and the degree of associated nasal deformity. The alveolar (maxillary) segments assume one of four positions:
- Narrow-no collapse;
- Wide-no collapse; and
"Wide" is determined by an alveolus position lateral to the desired alar base position (i.e., with lip closure the alar base is sitting in the cleft). "Collapse" refers to a palatal displacement of the lateral maxillary segment as predicated by the arch configuration of the medial, noncleft dental ridge. Clefts characterized as "narrow-no collapse" with minimal nasal deformity are treated with presurgical taping to prevent widening of the cleft with growth and feeding, prior to a primary CL repair with primary tip rhinoplasty. If a gingivoperiosteoplasty is to be performed at the same time, a molding plate can be used to optimize contact of the opposing alveolar ridges. Clefts characterized as "narrow-collapse" or "wide-collapse" benefit from presurgical molding to create the desired arch form, alveolar contact, and nasal anatomy at the time of surgery. Clefts characterized as "wide-collapse" or "wide-no collapse" must be assessed closely by the dental members of the cleft team. If they feel that these cases are deficient in arch mesenchyme, presurgical orthopedics is used to align the arch segments by correcting the collapse, but not to close the alveolar cleft since this will result in a constricted arch. External taping can be used to correct the alar base position over the maintained arch form. The use of presurgical orthopedics or aggressive presurgical taping has eliminated the need for preliminary lip adhesion surgery at most centers. 
In infants with bilateral clefts of the lip alveolus and palate, the objective of presurgical NAM includes the nonsurgical elongation of the columella, centering of the premaxilla along the midsagittal plane, and retraction of the premaxilla in a slow and gentle process to achieve continuity with the posterior alveolar cleft segments. Additional objectives include a reduction in the width of the nasal tip, improved nasal tip projection, and a decrease in the nasal alar base width.  The key point of nasal molding in bilateral clefts is to push the alar domes forward in a sagittal direction for columella lengthening instead of pushing the domes upward in a cephalic direction into a turned-up nasal tip. 
| Protocol for NAM Therapy|| |
The treatment outcome of presurgical NAM therapy depends on proper case selection, appropriate appliance design and proper motivation of the caretakers. Once the above criteria are met, then the commonly followed steps in NAM are:
- Impression technique
- Fabrication of appliance
- Insertion of appliance
- Adjustment of appliance
- Incorporation of nasal stent
- Final impression.
Research reports revealed that various impression techniques were followed by the clinicians in presurgical NAM therapy. Grayson and Shetye  held the infant upside down while taking the impression. The impression tray is inserted into the oral cavity. The infant is held in an inverted position to prevent the tongue from falling back and to allow fluids to drain out of the oral cavity. The tray is seated until the impression material adequately covers the anatomy of the upper gum pads. He used a heavy body silicone impression material as it has good tear strength. Prasanth et al.,  and Retnakumari et al.,  used heavy body silicone impression material for taking impression, and the infant was kept in supine position during the procedure [Figure 1]. Dubey et al.,  kept the baby in mother's lap with head facing downward and her hands supporting baby's chest and lap region while making the impression. Yang et al.,  took alginate impressions using a pretrimmed customized pediatric tray. Utility wax was employed to avoid any sharp edges on the tray and to better adapt to the newborn's mouth. The impression was taken with the baby in the most upright position, being held by one of the parents. Alginate impression when used in thin sections has the disadvantage of breaking away from the tray when the tray is removed from the mouth. Such broken pieces may remain in deeper section of the cleft and may even enter the nasal cavity making their removal difficult. Karimi et al.,  used red impression compound to take the preliminary impression. Splengler et al.,  took intraoral and extraoral alginate impression with the patient under general anesthesia. This method is generally not recommended as the patient is subjected to hospitalization for an impression procedure.
Fabrication of NAM appliance
The NAM plate described by Grayson and Shetye  is made up of hard, clear self-cure acrylic and is trimmed with a denture soft material. A retention button is fabricated and positioned anteriorly at an angle of 40 degree to the plate. The vertical position of the retention arm should be at the junction of the upper and lower lip. The retention button adequately secures the molding plate in the mouth with the help of orthodontic elastics and tapes. A small opening measuring 6-8 mm in diameter is made on the palatal surface of the molding plate to provide an airway in the event that the plate drops down posteriorly. This is the most commonly used NAM appliance. ,,,, Various materials have been substituted for autopolymerizing resin in fabrication of the appliance by various researchers. They are light-cure polymerizing material (Yang et al.  ), heat-cure polymerizing material (Ma et al.,  and Karimi et al.  ) and thermoplastic base plate wax (Upadhyay et al.  ).
Insertion of appliance
The NAM appliance is secured extraorally to the cheeks and bilaterally by surgical tapes with orthodontic elastic bands at one end [Figure 2]. The elastic on the surgical tape is looped on the retention arm [Figure 3] of the molding plate and the tape is secured to the cheeks [Figure 4]. The elastics (inner diameter 0.25 inch, wall thickness heavy) should be stretched approximately two times their resting diameter for proper activation force of about 100 g. The amount of force could vary depending on clinical objective and the mucosal tolerance to ulceration. Additional tapes may be necessary to secure the horizontal tape to the cheeks. , Some authors advice the application of liquid adhesive on cheeks to secure the Steri tapes for better retention of the appliance.  Denture adhesive and tape-elastic system has been used by Shetty et al.,  for the same purpose.
Adjustment of the appliance
The baby is seen weekly to make adjustments to the molding plate to bring the alveolar segments together. These adjustments are made by selectively removing the hard acrylic and adding the soft denture base material to the molding plate [Figure 5]. At one visit not more than 1 mm of modification of the molding plate should be made. The alveolar segments should be directed to its final and optimal position. Care must be taken to prevent the soft denture material from building up on the height of the alveolar crest as this will prevent complete seating of the molding plate. ,,
Incorporation of nasal stent
A silicone nasal conformer suggested by Matsuo and Hirose  can be used as a tool for presurgical nasal molding when the patient has an incomplete CL. The height of the conformer can be adjusted by gradually adding some soft resin or flat silicone sheets on the domes. This is a method to increase the columella height gradually by adding silicone sheets to the domes of the nasal stent. It can be used for presurgical elongation of the columella in incomplete clefts or postoperative maintenance of the nostril configuration. There are some limitations in this method. These include the need for an intact nasal floor (Simonart's band or lip adhesion) and the inability to direct the force because the stent expands circumferentially.
Grayson and Shetye  adapted nasal stent to extend from the anterior flange of an intraoral molding plate. The greatest advantage of NAM is that it enables the practitioner to apply force skillfully to shape the nasal cartilage. Because the stent is extended from a molding plate, an intact nasal floor is not required. According to the authors, when the alveolar gap is approximated and the arch is aligned, a nasal molding device is added to the orthopedic appliance to increase the columella length as well as to reshape the alar dome. The stent is made up of 0.36 inch, round stainless steel wire, and takes the shape of a 'Swan Neck'. The hard acrylic component is shaped into a bilobed form that resembles a kidney. A layer of soft denture liner is added to the hard acrylic for comfort. The upper lobe enters the nose and gently lifts forward the dome until a moderate amount of tissue blanching is evident. The lower lobe of the stent lifts the nostril apex and defines the top of the columella. The nasal stent component of the NAM appliance is incorporated when the width of the alveolar gap is reduced to about 5 mm. The rationale for delaying the addition of the nasal stent is that as the alveolar gap is reduced, the base of the nose and the lip segment alignment is also improved. The alar rim, which at birth was stretched over a wide alveolar cleft deformity, will show some laxity; and with the nasal stent, this can be elevated into a symmetrical and convex form.
In Figueroa's technique, alveolar and nasal molding are performed simultaneously using an acrylic plate with rigid acrylic nasal extension. Rubber bands are connected to the acrylic plate for gentle retraction of the premaxilla backward. A soft resin ball attaching to the acrylic plate across the prolabium is sometimes used to maintain the nasolabial angle.
The nasal components are made up of 0.028 inch stainless steel wire projecting forward and upward bilaterally from the anterior part of the dental plate in Liou's method. The top portion contains a soft resin molding bulb that fits underneath the nasal cartilages for nasal molding. In this method also, nasal and alveolar molding was done simultaneously. 
Liao et al.,  conducted a blinded, retrospective study of 58 patients with complete bilateral CLP, 27 patients received Grayson NAM and 31 patients received Figueroa NAM. Outcomes were compared by analyzing pre- and posttreatment facial photographs and clinical charts for efficacy (columella length ratio, alar width ratio, alar base width ratio, nostril shape, nasal tip angle, nasolabial angle, and nasal base angle), efficiency (molding frequency), and incidence of complications (facial irritation and oral mucosal ulceration). The results showed that Grayson and Figueroa NAM similarly improve nasal deformities and reduce alveolar gaps; however, the Figueroa technique is associated with less oral mucosal complication and more efficiency.
In bilateral cases, there is a need for two retention arms as well as two nasal stents [Figure 6] which are similar in shape to the unilateral stent. After adding the nasal stents in the bilateral cleft, the attention is focused on nonsurgical lengthening of the columella. To achieve this objective, a horizontal band of the denture material is added to join the left and right lower lobes of the nasal stent, spanning the base of the columella. This band sits at the nasolabial junction and defines this angle as the nasal tip continues to be lifted and projected forward. The tape is adhered to the prolabium underneath the horizontal lip tape and stretches downward to engage the retention arm with elastics. This vertical pull provides a counter stretch to the upward force applied to the nasal tip of the nasal stent. Taping downwards on the prolabium helps to lengthen the columella and vertically lengthens the often small prolabium. The horizontal lip tape is added after the prolabium tape is in place. 
|Figure 6: Nasoalveolar molding (NAM) appliance with two retention stops and two nasal stents for bilateral cleft lip and palate cases|
Click here to view
Splengler et al., in 2006  gave the flow chart which shows the protocol followed by them [Figure 7].
Shetty et al., used the following protocol for presurgical NAM therapy: 
Parent education and counseling:
- Use of audiovisual aids and live demonstrations
- Interaction with parents of older NAM patients
- Diet counseling
- Photographs - standard 1:1 ratio frontal and basilar view
- Dentofacial impressions
- Medical evaluation of patients
Fabrication of NAM appliance:
- >8-10 mm intersegment distance - alveolar molding
- <8-10 mm intersegment distance - NAM
Demonstration of home care instructions:
- Daily appliance care
- Awareness about possible complications and their management
Telephonic correspondence after 2 days to ascertain parent and patient compliance
Second visit (1 week subsequent to first visit):
Evaluation of patient and parent compliance.
- Photographs - standard 1:1 ratio frontal and basilar view
- Dentofacial impressions
Treatment outcome and assessment:
- Compatibility of appliance and required modifications
- <8-10 mm intersegment distance - initiate NAM
- >8-10 mm intersegment distance - aggressive alveolar molding
Recall visits every 3 weeks:
Evaluation of patient and parent compliance.
- Photographs - standard 1:1 ratio frontal and basilar view
- Alveolar surface impressions
- Dentofacial impressions recorded prior to primary lip repair
Treatment outcome and assessment:
- Compatibility of appliance and required modifications
- Nasal molding started at the earliest and continued till completion
- Active alveolar molding continued till completion
- Passive alveolar molding started once complete approximation of alveolar segment achieved
- Fabrication of new appliance every 2 months
- Parents participation in periodic NAM workshops.
Active and passive appliances
In literature there is no clear definition of active and passive appliances used in NAM therapy. The NAM appliances are classified as into pre- or postsurgical, active or passive, and intraoral or extraoral. Active maxillary appliances move alveolar cleft segments in a predetermined manner with controlled forces; whereas passive appliances deliver no force, but act as a fulcrum upon which the forces created by surgical lip closure contour and mold the alveolar segments in a predictable fashion. 
Donalb  states that active appliances are fixed intraorally and apply traction through mechanical means such as elastic chains, screws, and plates. Passive appliances maintain the distance between the two maxillary segments, while external force is applied to the primarily to reposition it posteriorly.
Neligan and Buck  mentioned that there are two dentofacial orthopedics passive and active. According to them, passive strategies include presurgical NAM and active strategies include latham appliance which is an intraoral active appliance custom-made on the infant's plaster cast of the palate. It is fixed on the palate by four 0.70 mm stainless steel pins on each side; a screw activated by the parent pulls the cleft segments into alignment over 3-6 weeks. Latham appliance facilitates only alveolar molding without nasal molding. In this article certain appliances described have an active component. They are modified muscle-activated maxillary orthopedic appliance used by Suri and Tompson  in NAM therapy; alveolar molding appliance with expansion screw described by Retnakumari et al.,  in their research report; dynamic presurgical nasal remodeling intraoral appliance designed by Bennun and Figueroa;  and self-retentive appliance with orthodontic wire used by Kamlesh Singh et al.,  in presurgical infant orthopedics.
Modified muscle-activated maxillary orthopedic appliance
Suri and Tompson  used a plate held in with outriggers, which prevents the cleft-widening effect of the tongue, helps with tongue tip placement, and utilizes the functional movements of the facial musculature to guide and relocate the major segment medially to its normal position in unilateral CLP cases. Nasal molding is undertaken after most of the lateromedial correction of the alveolar position. Stainless steel wire outriggers are bent in situ, which emerge from the cleft between the lip margins, and are gently contoured at an angle upward to end in oblong terminal loops lying beyond the modiolus region. The loops are bent in such a fashion that their long axes are roughly at right angles to an imaginary line extending from the lateral lip commissures to the superior surface of the helix of the external ear. This modified technique, which amalgamates nasal molding with a muscle-activated alveolar molding infant orthopedic plate, helps to improve alveolar position, nasal septum alignment, nasal symmetry, and nasal tip projection prior to the primary lip and nasal surgical repair.
Dynamic presurgical nasal remodeling
The newly designed intraoral appliance by Bennun and Figueroa  consists of two elements: A perfectly adapted conventional acrylic intraoral plate, which is left loose in the mouth of the neonate, and a dynamic nasal bumper attached to the vestibular flange of the intraoral plate. It is placed lateral to the plate midline, in line with the lip and alveolar cleft. In bilateral cases, two stents are used. The nasal stent has a directional component which is made of a U-shaped wire that can easily be bent. The two free ends are secured to the plate, and the base of the 'U' of the directional wire holds a soldered, vertical stainless steel bar or stent 2 mm in diameter. A dynamic component, a stainless steel open coil spring (2.2 mm diameter), is inserted over the stent. It is used to regulate the impact force and to reduce rebound of the nasal extension or bumper. The coil exerts a force of 70 g/m for each millimeter of compression. The coil is approximately 3 mm longer than the stent. Full compression of the stent can generate a force up to 210 g/m. A remodeling silicone component (bumper) is mechanically attached to the cranial aspect of the open coil spring. It is in direct contact with the intranasal soft tissues. It was designed to avoid soft tissue lesions in the delicate nasal mucosa and to obtain a superior remodeling effect of the nasal structures.
Active alveolar molding appliance [Figure 8]
A new approach in presurgical infant orthopedics using an alveolar molding plate with an expansion screw (Jack screw) fully opened, incorporated into the appliance. This formed the active component of the appliance for retraction of the protruded premaxilla. The anterior component of the appliance was fabricated with two retention stops. These retention stops facilitated the attachment of elastic traps on both sides. The appliance was activated by closing the expansion screw and by selective grinding and relining with denture base material. The premaxilla was retracted and the cleft gap was reduced with the use of this active alveolar molding appliance within 3 months. This enabled better esthetic results after surgery by reducing tissue tension and scar formation. 
NAM with self retentive plate
Ijaz  in his study on unilateral CLP cases used a custom-made orthopedic plate incorporating nasal stent, made from self-cure acrylic on the labial vestibular flange of the orthopedic plate. The nasoalveolar orthopedic plate was made self-retentive by adding soft acrylic on its palatal surface in the defect part. There was no need of any extra oral attachment As suggested by Grayson and Shetye  for retention of the appliance. The palatal surface of this orthopedic plate was adjusted fortnightly by adding over 1 mm of hard acrylic along the entire palatal surface, around the soft acrylic, followed by insertion and adaptation of the palate. Adhesive Steri strip 1/4΄ 4 inches was applied extraorally to facilitate approximation of the CL and alveolar segments.
Karimi et al.,  used a prosthesis made with a heat-cure acryl with a 3-4 mm extension into the nasal chamber. Most retention was assumed to be provided form palatal shelves of maxilla and nose chamber. Pronounced extension into the nasal chamber was avoided to reduce the risk of airway obstruction. As the details of inner nasal alar anatomy would not be recorded satisfactory; this part of prosthesis was molded again using tissue conditioner to ensure the maximal fitness. Five adjustment sessions were performed in every other day. A week after the prosthesis was delivered to the parents, two crossed straps which were secured to a head cap at the sides were added to augment the posterior protraction of the displaced premaxillary segment and corresponding soft tissue.
Ijaz  designed a custom made orthopedic plate incorporating a self-cure acrylic ring around the protruding premaxilla. The plate was made self-retentive by addition of soft acrylic on its palatal surface, filling the cleft area. This innovative self retentive plate was made up of acrylic which comprised of two parts; the palatal plate covered the palatal defect and served as a passive obturator and the anterior part of the plate extended as a ring around the protruded and deviated premaxilla. This ring acted as an active part to align and retract the malposed premaxillary segment.
The modified appliance used by Kamlesh Singh et al.,  is nearly the same as described by Grayson and Cutting except that they used an orthodontic wire covered the nasal tip cartilage, proximity of the lip segments, and convexity in the alar base with an acrylic bulb to give pressure for active molding. This appliance does not need any further addition of acrylic every week, only wire angle is increased a bit to increase the pressure exerted.
| Discussion|| |
NAM is used effectively to reshape the nasal cartilage and mold the maxillary arch before CL repair and primary rhinoplasty. Nasal deformity in infants with nasolabial clefts persists if it is not actively corrected. The principle objective of presurgical NAM is to reduce initial cleft deformity. This enables the surgeon and the patient to enjoy the benefits associated with repair of a cleft deformity. The goals of PNAM are to align the intraoral alveolar segments and correct the nasal tip, the alar base, the philtrum, and the columella.
Advantages of NAM technique
NAM device approximates the alveolar segments as close as possible before surgery and brings the premaxilla back into the position of the alveolar arch in bilateral cleft patients. , When combined with primary gingivoperiosteoplasty (GPP), this potentially results in a reduced need for alveolar bone grafting during the mixed dentition period. In addition, there are several other advantages to using a prosthetic device to place a premaxilla in a more anatomically correct position before surgical closure of the lip. First, soft tissue will be carried with the segment, leading to a decrease in the width of the defect. , Second, a centrally positioned premaxillary segment provides a more ideal base for lip closure. , It decreases tissue tension during the surgical procedure, and finally, it allows healed soft tissues to rest against a more normal bony anatomy. If the premaxilla is not repositioned in these extreme cases, excessive tension may develop at the surgical site, which compromises the surgical result. By using orthopedic therapy, a second operative session may be eliminated, thereby decreasing total hospitalization time and cost. Besides the intraoral advantages of NAM, there are also significant benefits in helping to correct the external nasolabial deformities. In unilateral cleft patients, the nasal stent is positioned so that the columella and septum are molded to a more vertical and upright position.  This will help correct the deviation of the columella base to the noncleft side. With careful adjustments, the alar cartilage can be molded into a more normal convexity and bilateral symmetry can be achieved without additional soft tissue surgery or scarring. 
Disadvantages of NAM
The disadvantages mentioned by various researchers are locked out segment, nostril overexpansion, irritation to skin and mucosa, exposure of primary tooth bud, obstruction of airway due to dislodgement of NAM appliance, and relapse of the molded cartilages though not entirely to some extent back to the original position.
Locked out segment
The most common hard tissue complication associated with the presurgical NAM device is misdirected molding of the alveolar segments. This only results if there is poor management of the molding process. It may be remedied through corrective molding if recognized early. If the greater segment is directed posteriorly more quickly than the lesser segment advances outward, the cleft may close with the lesser segment locked behind the greater segment. ,,
A potential soft tissue complication would be overexpansion of the alar rim as a result of premature stenting before sufficient closure of the cleft gap (5 mm). Again, direction of tissue expansion and progress must be monitored on a weekly basis to avoid this occurrence. ,,
Soft tissue irritation
The most common problems observed during NAM therapy are irritation to the oral mucosa, gingival tissue or nasal mucosa. Intraoral tissues may ulcerate from excessive pressure applied by the appliance. These are commonly found in the oral vestibule and on the labial side of the premaxilla. The oral and the nasal cavities of the infant should be carefully examined on each visit for ulceration and appropriate adjustments should be made to the molding plate to relieve sore spots. The intranasal lining of the nasal tip can become inflamed if too much force is applied by the upper lobe of the nasal stent. The area under the horizontal prolabium band can become ulcerated if the band is too tight. ,
Another area of tissue irritation is the cheeks. Extreme care should be taken while removing the cheek tape to avoid any irritation to the skin. Skin barrier tapes like Tegaderm TM are recommended. Slight relocation of the position of the tape during treatment is also recommended to provide rest to the tissues in case they become irritated. It is also recommended that an aloe vera gel be applied to the cheeks when changing tapes.
Exposure of primary tooth bud
Sometimes exposure of primary tooth bud may occur due to the pressure applied during active molding. 
Obstruction of airway
If there is no proper retention, the appliance may dislodge posteriorly and obstruct airway, for this always a hole should be incorporated in the appliance in center of palatal region of the molding plate. 
Pai et al.,  has reported that patients who have received NAM therapy has relapse of nostril shape in width (10%), height (20%), and angle of columella (4.7%) at 1 year of age.
It is imperative that parents become active members of the treatment team. If the appliance is lost or not worn, a cleft gap that had been closed early during molding therapy may widen again as the infant places his or her tongue into the cleft. Compliance is an essential factor with this method of treatment.
Many studies [Table 1] and [Table 2] have been performed to assess the outcome of NAM. Universally authors have agreed the positive outcome of NAM for better esthetics after CLP are repaired. But the long-term effects of this therapy are yet to be substantiated.
|Table 1: Studies in relation to nasoalveolar molding (NAM) in unilateral cleft lip and palate |
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|Table 2: Studies in relation to nasoalveolar molding (NAM) in bilateral cleft lip and palate |
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| Conclusion|| |
The NAM technique has been significantly shown to improve the surgical outcome of CLP patients compared with other techniques of presurgical orthopedics. NAM has proved to be an effective adjunctive therapy for reducing hard and soft tissue cleft deformity before surgery. However, it is important that parents or caregivers become active members of the treatment team. Similarly, it is crucial that members of the cleft team provide the parents and caregivers adequate training, education, active support, and encouragement during NAM treatment. Lack of parent or caregivers' compliance and commitment results in less than ideal clinical outcomes. Despite a relative paucity of high-level evidence, NAM appears to be a promising technique that deserves further study. The long-term effectiveness of NAM is still to be evaluated as very few studies with long-term follow-up are available.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
[Table 1], [Table 2]