|Year : 2015 | Volume
| Issue : 2 | Page : 98-104
Presurgical nasoalveolar molding in patients with unilateral and bilateral clefts-changing concepts and current approach
Taruna Puri1, Dolly Patel2
1 Department of Orthodontics and Dentofacial Orthopaedics, Bhojia Dental College and Hospital, Baddi, Himachal Padesh, India
2 Department of Orthodontics and Dentofacial Orthopaedics, AMC Dental College and Hospital, Ahmedabad, Gujarat, India
|Date of Web Publication||17-Aug-2015|
Dr. Taruna Puri
E-33, GHS-94, PGI Enclave Sector-20, Panchkula, Haryana
Source of Support: None, Conflict of Interest: None
Nasoalveolar reconstruction for patients with cleft lip and palate is a challenging job for the surgeon. Many procedures to obtain esthetic results and decrease the cleft gap have been suggested. Presurgical nasoalveolar molding is used as an adjunct for reshaping the alveolar and nasal segments prior to surgical repair. Rehabilitation of cleft lip and palate usually requires a team approach which includes a plastic surgeon, orthodontist, speech therapist, pediatrician and a prosthodontist. In the recent times there have been many controversies regarding the same concept. This paper describes the changing concepts in the treatment of patients with cleft lip and palate, discusses the various views given by different individuals, focuses on the current concepts and also on the long-term benefits of the same. With time, the concept of treatment of cleft lip and palate has changed. Nowadays more emphasis is laid on the nasal and alveolar molding prior to the primary surgical lip repair. This molding reduces the number of revision surgeries to be performed later.
Keywords: Cleft lip and palate, gingivoperiosteoplasty, nasal molding, presurgical nasoalveolar molding
|How to cite this article:|
Puri T, Patel D. Presurgical nasoalveolar molding in patients with unilateral and bilateral clefts-changing concepts and current approach. J Cleft Lip Palate Craniofac Anomal 2015;2:98-104
|How to cite this URL:|
Puri T, Patel D. Presurgical nasoalveolar molding in patients with unilateral and bilateral clefts-changing concepts and current approach. J Cleft Lip Palate Craniofac Anomal [serial online] 2015 [cited 2021 May 15];2:98-104. Available from: https://www.jclpca.org/text.asp?2015/2/2/98/162962
| Introduction|| |
Cleft lip and palate, which is said to be the most common congenital craniofacial anomaly has a great negative social impact on the patient and his/her family.  Classical cleft nasal deformity arises in the fetal period secondary to the primary cleft lip and palate malformation. It presents itself as a typical abnormal form or position of the nasal structures. Although the nasal deformity follows a pattern, severity of the deformity depends upon the underlying soft and hard tissue defect.  Although treatable, the kind of treatment of cleft lip and palate depends on the cleft type and its severity.  In the cleft literature, nasoalveolar molding (NAM) has garnered attention over the last decade as a new option for improving nasal form and symmetry before primary surgical repair, but the systematic review of the evidence is currently lacking. The aim of this review article is to assess the changing concepts and views regarding NAM.
| Clinical Features in Patients with Unilateral Cleft Lip and Palate|| |
Patients with unilateral cleft lip and palate (UCLP) present with a multitude of problems on the cleft side. Problems on the cleft side include facial asymmetry due to deviation of nasal tip, deformed nasal dome with significant flattening, outwardly rotated premaxilla, posteriorly displaced lateral segment, inferior septum dislocated out of the vomerine groove, unilateral shortness of columellar and philtral height and disrupted orbicularis oris ending at the cleft margins.
The lower lateral alar cartilage on the cleft side is often concave where it ought to be convex. The nostril apex is low on the cleft side, and the alar rim is stretched in the horizontal plane.
| Clinical Features in Patients with Bilateral Cleft Lip and Palate|| |
- The mucocutaneous ridge or white roll is deprived of angular peaks and dips of a typical cupid's bow are absent.
- The prolabium is continuous with base of columella with absence of philtral depression.
- Columella is abnormally short and widened in its lower part.
- Columella is elevated by the premaxilla, which tends to project outwards. This causes the appearance of a transverse crease at the labio-columellar junction. 
- The mucosal zone is often underdeveloped and coated by layer of desquamative scabs.
- The vestibule is either absent or there is a presence of a furrow, which is very frequently ulcerated.
- The lateral elements of the lip may seem to dangle well behind the premaxilla.
- In symmetrical forms of bilateral cleft lip the nose is not deviated. Its tip is flattened and widened.
- The septal cartilage is often underdeveloped.
Nasal deformity increases with the time if left untreated. Unrepaired nasal deformity also leaves the stigmata of cleft till the adolescence. Furthermore, secondary correction of the nasal deformity would lead to more surgical scarring and less than ideal results. Therefore correction of the cleft nasal deformity has been the greatest challenge to the cleft surgeons and hence any form of the nonsurgical treatment to reduce the nasal deformity early in the life is highly desirable. Matsuo et al. , were the first to attempt the presurgical nasal correction.
Objectives of presurgical nasoalveolar molding
- Reduction of cleft size by guiding growth and functional rehabilitation.
- Restore physiologic continuity of the dental arch to maintain oral and dental health.
- To achieve an optimal alignment of the cleft segments within the first few months of infancy prior to cheiloplasty.
- To allow a surgical repair with minimal tension.
- To reduce the protrusive position of the alveolar processes.
- To prevent tongue from seating into cleft palatal region thus facilitating transverse growth of palatal shelves.
- To actively mold and reposition the deformed nasal cartilages.
- To lengthen the columella.
- To straighten the columella and correction of alar cartilage displacement.
Pritchard (1946) has suggested that bone healing was inversely proportional to the size of cleft that is, larger the cleft slower is the bone healing. Hence, presurgical NAM (PNAM) is recommended to produce more favorable bone formation by reducing the size of the cleft. 
- To reduce the need for secondary alveolar bone grafting.
| Controversies Regarding Presurgical Nasoalveolar Molding|| |
Presurgical nasoalveolar molding in cleft patients has been a subject of great debate and controversy in the recent times. Some are in favor of it and are of the view that it has got many benefits for the patient, but others are of the view that it is an unnecessary burden to the patient and his/her family, with no added advantage.
| Studies Done on Presurgical Nasoalveolar Molding|| |
Grayson and Cutting , stated in their article that the long-term aesthetics in both bilateral and unilateral cleft patients are improved with PNAM. They concluded that PNAM:
- Improved long-term nasal aesthetics.
- Reduced the number of nasal surgical procedures.
- Reduced the need for secondary alveolar bone grafts in the majority of patients if gingivoperiosteoplasty is included in the protocol.
- No greater growth disturbance than is found in cleft patients undergoing good traditional treatments.
- Savings in the cost to the patient and society through the reduction in the number of surgical hospital admissions.
Lee et al.  stated that PNAM had advantages from both a soft tissue perspective as well as from the usual osseous perspective. The presurgical reduction in soft tissue and cartilaginous deformity facilitates achievement of surgical soft tissue repair under minimal tension and optimal conditions for scar formation. Furthermore, the need for minor soft tissue revision surgeries required to maintain acceptable nasolabial esthetics also decreased.
Ross  carried out a major multicenter study and stated that there was no difference in facial growth between cleft patients who were treated with or without presurgical orthopedics. Wood et al. , and Lee et al.  also showed that maxillary growth was not hampered in patients who underwent presurgical orthopedic closure of the cleft alveolar gap, followed by the primary gingivoperiosteoplasty as suggested by Millard and Latham (1990).
| Concept of Nasal Molding|| |
Maull et al.  reported on the long-term stability of nasal symmetry and stated that PNAM was shown to significantly increase symmetry of the nose which was maintained into early childhood. As the nasolabial defect influences the physical appearance of the child, it is recommended to perform nasal molding prior to primary lip repair. As suggested by Millard (1984) clefting is due to disturbance of embryogenesis and therefore proper closure of all involved structures should be achieved as soon as possible to favor normal growth of the face. Several approaches have been used in order to reduce the nasal asymmetry early in life using surgery alone or in conjunction with other approaches. Matsuo et al., designed a nasal stent for the correction of the nasal deformity but its drawback was that it required an intact nostril floor. Therefore in the cases without nasal floor, a primary lip adhesion has to be done in order to make stenting possible. Grayson et al. , added a nasal stent to presurgical alveolar molding plate, which did not require the presence of intact nasal floor and could exert a controlled force. Doruk and Kiliç modified the extraoral nasal molding appliance and its advantage was that there was no need for nasal impressions and the same appliance could be used for different patients after sterilization. 
Studies conducted to assess the nasal changes after PNAM by evaluating the casts after nasoalveolar molding (NAM) revealed that this therapy significantly improved the nasal symmetry. Columella deviation, length and width were also significantly improved as suggested by Spengler et al.  Similar results were reported by Pai et al. who performed the evaluation based on the photographic analysis. However, some amount of relapse of the nostril width, height and angle of columella were observed at 1-year of age.  However, early primary rhinoplasty procedures initially yielded good results, but due to the inherent dysmorphology of the nasal cartilages and due to the contractures after surgical repair, there was a return of original deformity. Cobley et al.  have modified the stent so that it can be removed and cleaned to maintain hygiene and also maintain the airway patent.
Cenzi and Guarda suggested dynamic nasal splint, which acts by applying gradual orthopedic force. It consists of an expansion screw, which is to be worn for 40-60 days for 15-18 h/day and later the appliance is kept inactive for a period of 3-4 months. This is generally recommended after 4-5 years of age when the patient is cooperative and accepts the nasal splint. 
Punga and Sharma carried out a comparative evaluation of PNAM cases done with and without nasal stents. The results showed that the increase in the columella length and increase of the nasal tip projection was statistically significant in cases with nasal stents as compared to the control group. 
Nagraj et al. introduced a double-loop technique for fabrication of nasal stents in NAM therapy for cleft lip and palate patients. NAM appliance is modified by using 0.032-inch titanium-molybdenum alloy wire for nasal stents incorporating a double-loop. The nasal stents are included in the acrylic molding plate at the time the appliance is inserted. The acrylic retention button used in a conventional appliance is replaced by a simple retention hook fabricated using titanium-molybdenum alloy wire. This technique is an effective alternative to a conventional appliance, and it simplifies the appliance modification process during follow-up visits. Chang et al. conducted a study to evaluate progressive changes in surgical techniques and results, aiming for improved nasal shape in primary bilateral cleft rhinoplasty. They divided their ninety-one patients into five groups as follows: Group I, primary rhinoplasty alone; group II, NAM alone; group III, NAM plus primary rhinoplasty; group IV, NAM plus primary rhinoplasty with overcorrection; and group V, patients without cleft lip. The results revealed that group IV that is, PNAM followed by primary rhinoplasty with overcorrection resulted in a nasal appearance that was closer to the patients without cleft lip. 
Liao et al. compared outcomes of two NAM techniques (Grayson and Figueroa techniques) for bilateral cleft nose deformity. With the Grayson technique, nasal molding is started when the alveolar gap is reduced to 5 mm, whereas with the Figueroa technique, nasal molding and alveolar molding are performed at the same time. The results showed that both Grayson and Figueroa NAM similarly improve nasal deformities and reduce alveolar gaps; however, the Figueroa technique is associated with fewer oral mucosal complications and more efficiency. Also Grayson NAM was less efficient (i.e., required more adjustments) and had a higher incidence of oral mucosal ulceration. 
Liao et al. carried out a similar study by comparing outcomes of two nasoalveolar molding techniques for unilateral cleft nose deformity. The results showed that Grayson and Figueroa techniques did not differ in treatment efficacy for nostril height ratio and columellar angle. Although the Grayson technique was more effective for reducing nostril width ratio, it was less efficient (i.e., required more adjustments) and had a higher incidence of mucosal ulceration. 
Alajmi et al. gave a simple formula based on the Pythagorean theorem to estimate the corrected height of the nose as an objective guide for the endpoint of NAM therapy. This formula is a useful guide for clinicians who begin to use NAM, with an objective measure to guide NAM treatment.  The NAM techniques differed in efficacy, efficiency, and incidence of complications in patients with complete UCLP. Understanding these differences may help surgeons and orthodontists improve outcome expectations and consultations with patients' families.
| Concept of Gingivoperiosteoplasty|| |
Santiago et al.,  stated that gingivoperiosteoplasty eliminates the need for secondary alveolar bone grafting in 60% of cases treated with presurgical orthopedics. The combined benefits of PNAM and gingivoperiosteoplasty have been shown to reduce the overall cost of therapy.  Skoog (1965) initially described surgical bridging of the cleft alveolar process with periosteal flap as a means of stabilizing the separated segments of the maxilla. He suggested that repair of the cleft lip is incomplete without the simultaneous reconstruction of bone defect of the maxilla by gingivoperiosteoplasty, as there is a risk of collapse of the lateral segments of the maxilla due to the pressure exerted by the repaired lip. Furthermore it is suggested that it coordinates the growth at the growth centers as the maxillary discontinuity is restored. , However, controversies exist regarding the conduct of gingivoperiosteoplasty in cleft patients because of its potential to impair maxillary growth. The concept of gingivoperioplasty has changed since the time of its introduction by Skoog in 1967. Skoog necessitated wide mucoperiosteal dissection to mobilize the flaps enough to allow for approximation of cleft alveolus as he did not perform PNAM. Current technique introduced by Millard and Latham (1990) is performed after the presurgical orthopedic closure of the cleft alveolar gap. Strict association of PNAM and alveolar gap closure allow gingivoperiosteoplasty to be performed. Studies have indicated that there is no need for alveolar bone graft if gingivoperioplasty is performed in infancy and also there is greater cost savings in patients undergoing NAM combined with gingivoperiosteoplasty as there is no need for further bone grafting and nasal revision surgeries.  Several studies have demonstrated the high osteogenic potential of the periosteum which leads to deposition of bone without subsequent resorption in the patients undergoing gingivoperiosteoplasty. , However, some other studies have shown higher frequency of anterior crossbite in patients treated with gingivoperiosteoplasty. ,, Therefore more long-term studies might be required to assess the effect of gingivoperiosteoplasty in cleft patients. However, gingivoperiosteoplasty has got following benefits:
- Helps in fistula closure.
- Provides stability to the jaw and more anatomical conditions for growth.
- Establishes intact maxillary dental arch at an early age.
- Facilitates correct eruption path for the permanent teeth.
- Prevents the need for bone graft thereby preventing traumatic injury to the donor site.
| Concept of Alveolar Molding|| |
In the presurgical alveolar molding protocol as described by Grayson et al. (1999), a conventional intra oral molding plate is fabricated after making the intra oral impressions. This plate is modified at weekly intervals and is modified by 0.5-1 mm increments. In areas where movement is expected the appliance is selectively grinded and a soft denture liner is added in regions which require molding. This is similar to the Zurich type of molding device described by Hotz (1969). Lip taping increases the effectiveness of the appliance and produces controlled orthopedic force which helps the molding plate to guide the alveolar segments in position. ,,, Various studies have been conducted to evaluate the effect of NAM. Study conducted by Ezzat et al. has shown statistically significant reduction in the inter segmental distance that is, in the cleft gap with no arch collapse as there was an increase in maxillary arch width.  Baek and Son carried out a three-dimensional analysis of the effect of alveolar molding and suggested that the cleft gap was significantly reduced. It was also found that alveolar molding took place mainly in the anterior alveolar segment and growth occurred mainly in the posterior alveolar segment.  Study conducted by Spengler et al.  on bilateral cleft lip and palate patients has shown that with PNAM there was a significant improvement in the nasal symmetry, protruded premaxillary segment was forced into alignment with dentoalveolar segments and the shape of the arch was improved. In contradiction to the above views, Bongaarts et al.  reported that infant orthopedics does not have any influence on the maxillary arch dimensions. The timing of repair of the defect also plays an essential role. As described by Matsuo, the earlier the intervention is initiated the better are the results. A study conducted by Shetty et al. to evaluate the effect of NAM at different ages stated that favorable outcome was obtained when the treatment was initiated within 1-month of life; however, positive outcome was also achieved when the treatment was initiated within 5 months of life but to a lesser extent. 
Yu et al.  carried out a study to evaluate the effectiveness of computer-aided design NAM (CAD-NAM) on maxillary alveolar morphology in infants with UCLP. They concluded that the CAD-NAM effectively reduced the cleft gap, corrected the maxilla midline, and improved the sagittal length of the maxilla. The alveolar height decreased significantly after the treatment, which indicated that the traction force of the appliance may have obstructive effects on the vertical growth of the alveolar bone. Mishra et al.  conducted a study on North Indian population to evaluate the role of PNAM in correction of cleft lip nasal deformity for patients with unilateral and bilateral clefts of the lip. They concluded that NAM can be a useful and a cost effective adjunct for treatment of cleft lip nasal deformity and also number of future surgeries such as alveolar bone grafting and secondary rhinoplasties can be reduced in infants treated with NAM.
Wojciech Dec et al. reported in their study that PNAM and primary gingivoperiosteoplasty reduce the need for bone grafting in patients with bilateral clefts. 
Barry H. Grayson et al. carried out a study for assessment of presurgical clefts and predicted surgical outcome in patients treated with and without NAM. Their study suggests that cleft surgeons assess NAM-prepared patients as more likely to have less severe clefts, to be among the best of their surgical outcomes, and to be less likely to need revision surgery when compared with patients not prepared with NAM. 
| Complications of Presurgical Nasoalveolar Molding|| |
Presurgical nasoalveolar molding is most effective with full time wear, but full time wear can be associated with certain complications like ulceration, tissue irritation, fungal infections and bleeding. Excessive activation or pressure from the molding plate can lead to soft tissue ulcerations. These ulcerations heal with the selective trimming of the molding plate. Improper maintenance of the hygiene with the full time wear of molding plate can also result in fungal infection, which can be treated by Nystatin or Amphotericin. However, the NAM therapy should continue during the treatment phase. Another complication is a rash like area of erythema and chafing on the cheek due to extraoral taping, but these are generally self-limiting and the best way to prevent these rashes is to wet the tape thoroughly before removal of the same.
Excessive pressure on the nasal cartilage can result in meganostril, which occurs due to an excessive increase in the circumference of the nostril due to improper stent positioning or nasal over-contouring.
Controversies also exist regarding overcorrection to compensate for the relapse. One group suggests slight orthopedic over correction of the alar dome (Singh et al. 2005)  while other group suggested vertical surgical nasal over correction (Liou E et al. 2004).  However, over correction has its own disadvantages like clinically seen external bruising or petechiae in the area of insult. Some hard tissues complications are also associated with NAM like excessive rotation of the lesser segment to meet the greater segment in a perpendicular manner, resulting in asymmetric T shaped configuration. Therefore, proper care should be taken to modify and monitor the segment movement. Another hard tissue complication involves eruption of the teeth, which could be due to the pressure exerted on the gingival tissues by the molding appliance. Modification of the appliance can be done to allow for favorable eruption of the teeth.
| Conclusion|| |
Controversies have been traditionally linked with PNAM. Although surgical procedures remain the principal element for rehabilitation of cleft lip and palate, PNAM techniques have made the rehabilitation much more esthetically acceptable and physiologically apt. The malleability of the paraoral structures in the early age is utilized for selectively controlling growth patterns with the use of NAM techniques. Such molding of the nasal cartilage, premaxilla and alveolar ridges in the neonatal period serves as an adjunct to the surgical procedures; it results in better esthetics and reliable long-term results. Nasal molding seems to be more beneficial and effective with better long-term results, however, the effect of alveolar molding needs to be studied further to assess the long-term beneficial effects. When gingivoperiosteoplasty was performed along with primary lip repair much better results were obtained. Hence in the present times a thorough knowledge of the changing concepts regarding NAM and timing of the initiation of the same is essential for early and successful rehabilitation of the cleft. Although significant improvement in the results have been shown by some studies, but these studies have some inherent drawbacks as they are performed on small patient groups and they lack a control group that is, subjects who do not undergo alveolar molding. Furthermore, long-term effects of nasolaveolar molding have not been evaluated, therefore further studies evaluating the long-term effects of PNAM are required to conclude firmly regarding the benefits of PNAM.
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