Key Words: Presurgical orthopaedics, Cleft lip and palate, Nasoalveolar molding
Cleft lip and palate is the second most common congenital abnormality in the body and the commonest in the head and neck region. According to the global epidemiological survey, one in every 700 suffers from cleft palate. The incidence in Sri Lanka was reported to be over 350 CLP/year. Bilateral cleft lip and palate is less common than unilateral cleft and has overall incidence of approximately 1 in 3000 to 1 in 4000 births. As with the unilateral cleft, a wide range of clinical presentations of the bilateral cleft lip and palate is possible, from the simple microform cleft to the complete cleft bilaterally involving the lip, alveolus, palate, and nose. Difficulty in management varies from management of simple incomplete bilateral cleft to management severe pre maxilary protrusion. The principal of surgical treatment in cleft lip and palate is restoring physiology and anatomy of the lip, nasal and alveolar components and the palate. Fully separated and displaced cleft, which is deficient in hard and soft tissue elements, present a signiﬁcant surgical challenge in achieving a functional and cosmetic outcome. Its generally understood that final outcome would be better in an infant who presents with a minor cleft deformity. The principal objective of presurgical orthopaedics is to reduce the severity of the initial cleft deformity.
Presurgical orthopaedics has been used in the treatment of cleft lip and palate patients for centuries. There is evidence from the 16th century of attempting in retraction of protrusive premaxilla in bilateral cleft lip and palate (BCLP) patients in order to reduce the severity of the deformity before primary surgical repair. Hoffmann in 1689 described the use of facial binding to narrow the cleft and prevent post surgical dehiscence. Presurgical orthopaedics of clefts using an adhesive tape binding was introduced by Hullihen In 1844. This technique is still used in many cleft centers of the world. McNeilin in 1950 introduced modern techniques of pre-surgical orthopaedic treatment in cleft lip and plate using a series of plates to actively mold the alveolar segments into the desired position. Latham in 1975, introduced a pin-retained active appliance which act very rapidly to simultaneously retract the premaxilla and expand the posterior segments over a period of several days. As this was a very invasive procedure it did not gain much popularity. In 1993, Grayson et al,. described a new technique to pre-surgically mold the alveolus, lip and nose in infants born with cleft lip and palate using nasoalveolar molding appliance (NAM).The NAM consists of an intraoral molding plate with nasal stents to mold the alveolar ridge and nasal cartilage simultaneously. A modified pre-surgical NAM technique was described by Eric Liou in 2003.Both authors underwent training on modified pre surgical NAM technique in Chang Gung Memorial Hospital in Taiwan and modified pre surgical NAM technique was started in Smile Train cleft center, peradeniya Sri Lanka in 2009.
Microspore tape is used for lip taping with Duo Derm as an alternative for patient with plaster allergy. It is necessary to teach the parents about taping which has to changed daily. Usually during the second visit we deliver the molding plate. The plate should reline with the soft resin and it is possible to start alveolar molding at this stage. The parents should be educated on how to insert the plate and apply tape- elastic system. It is necessary to repeat the molding procedures until the alveolar cleft is less than 5mm prior to columella lengthening.
It has been shown that after the birth there are elevated levels of circulating maternal estrogen in the infant’s bloodstream, gradually declining up to two months. During that period plasticity of the nasal cartilages is increased and has the ability to permanently modify it’s shape. NAM was developed on this basis. The main objectives of pre-surgical NAM can be summarizes as
1. Active molding, providing symmetry and repositioning of nasal and alveolar processes;
2. Non-surgical lengthening of the columella;
3. Facilitating lip repair without scarring by placing the lip segments in a more anatomical position and reducing the distance between cleft lip segments;
4. Improving nasal correction and providing projection for a flat nasal tip;
5. Serving as an obturator to help infant in suckling.
In our center we use the NAM only for severely displaced bilateral cleft lip and palate and we were able to achieve the desired effect most of them (Fig. 1, 2 ,3, 4 and 5). A study done by Garfinkle et al., in 2011 in which he observed two groups of BCLP patients and non-cleft samples up to 12 years. The BCLP group was treated with NAM and primary lip and nose surgery. He was able to show that the BLCP group treated with NAM prior to surgery achieved near normal appearance compatible with normal children at age of 12 years.
There are some known complications of pre-surgical NAM on infant with cleft lip and palate. Levy-Bercowski D. et al., categorized complications of pre-surgical NAM which can be summarized as
1. Soft tissue complications : such as mucosal ulceration, intraoral bleeding, tissue fungal infections, tissue irritation, mega nostril, impingement of nasal epithelium, and nasal bleeding.He has shown that soft tissue irritation was the most common and the nasal bleeding was the least common complication of NAM.
Some of the patients in our center presented with uncontrollable skin irritation of the skin over the cheek and we were able to continue appliance with the use of innovative cloth headgear design by one mother of the cleft child (fig 9).
2. Hard tissue complications: During the process of modifying the internal surface of the appliance to approximate the alveolar greater and lesser segments, the lesser segment might rotate excessively so as to approach the major segment in a perpendicular manner, resulting in an asymmetric T-shaped configuration.
During the activation of the NAM care must be taken by the clinician to properly modify and monitor segment movements in order to avoid this problem. When such a scenario occurs, the segment relationship should be restored by expanding the alveolar segments and redirecting proper gap closure before the surgery.
Another infrequent complication of the hard tissues involves the pre-mature eruption of primary maxillary incisors through overlying gingival tissue as a result of the pressure exerted by the molding plate (Ziai et al., 2005).These teeth can be extracted if they are ectopic, supernumerary, mobile or interferes with proper activation of the appliance. (Grayson et al., 1999).
3. Compliance for the treatment by parents, patients and , removal of the appliance by tongue or hands are some of such issues.
Compliance is the key for the successful treatment of NAM. Irregular attendance often result in prolonged treatment or compromised final outcomes and may result in additional surgeries (Yang et al., 2003; Pai et al., 2005). NAM therapy is time consuming to the clinician, families, for example in some cases requiring hours of travel to treatment centers each week and long time spent in the waiting area. In our center we try to minimize the waiting time and we provide transport allowance to the care givers. Successful therapy involves a considerable commitment on the part of parents/care givers. They must be properly educated and motivated about NAM treatment, and audio visual aids should be used to give adequate information to the decision makers about the risks and potential benefits related to NAM therapy. The parents/ care givers may be largely benefited by seeing previously treated patients and by sharing treatment experiences with other affected families. In our center we have a parental support group, information booklets are provided and extensive counseling for the caregivers/parents before starting the NAM.
Written consent for treatment is taken after explaining the procedure to the parents / caregivers. Successful outcome is largely depending on compliance of the patient, parents or caregivers. Hard and soft tissue complications can be managed by the clinician without the need for suspending the treatment.
There are several benefits of the nasoalveolar molding (NAM) technique in the treatment of severely displaced cleft lip and palate deformity. A proper alignment of the alveolus, lip and the nose helps the surgeon to achieve a better and more predictable surgical result.
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