Complications and Solutions in Presurgical Nasoalveolar Molding Therapy

Daniel Levy-Bercowski, D.D.S., M.S.D., Amara Abreu, D.D.S., M.S.D., Eladio DeLeon, D.M.D., M.S., Stephen Looney, Ph.D., John Stockstill, D.D.S., M.S., Michael Weiler, D.M.D., Pedro E. Santiago, D.M.D.
Objective: To outline three main categories of nasoalveolar molding complications, describe their etiologies and manifestations, and prescribe preventive and palliative therapy for their proper management. Estimates of the incidence of each complication also are provided. Materials and Methods: Data were collected retrospectively from the charts of 27 patients with complete unilateral cleft lip and palate treated by the first author (D.L.-B.) at the University of Puerto Rico (n = 12) and the Medical College of Georgia (n = 15). Confidence intervals for the true incidence of each complication were calculated using exact methods based on the binomial distribution. A significance level of .05 was used for all statistical tests. Results: Of the soft and hard tissue complications considered, only one (tissue irritation) had an estimated incidence greater than 10%. Compliance issues were of greater concern, with an estimated incidence of 30% for broken appointments and an estimated incidence of 26% for removal of the nasoalveolar molding appliance by the tongue. Conclusions: Although benefits outnumber the complications, it is important to address all complications in order to prevent any deleterious outcomes. KEY WORDS: cleft lip and/or palate, complications, nasoalveolar molding, presurgical

Presurgical nasoalveolar molding (NAM) continues to play an increasingly significant role in neonatal cleft lip and/or palate (CL/P) treatment. McNeil articulated the modern concept of presurgical maxillary orthopedics in 1950 when he described the use of serial appliances to approximate cleft alveolar segments (Matsuo et al., 1984; Berkowitz, 2006). Based on the work of Matsuo, who described the plasticity of neonatal nasal cartilage (Matsuo et al., 1989; Matsuo and Hirose, 1991), Nakajima reported the successful use of nasal splints in maintaining nostril shape after primary lip closure (Nakajima et al., 1990); this supports the therapeutic concept of the NAM technique. NAM therapy in its present categorization was first described by Grayson in 1993 (Grayson et al., 1993; Grayson and Santiago, 1997; Grayson et al., 1999). This treatment modality has significantly enhanced the ability of

Dr. Levy-Bercowski is Assistant Professor, Orthodontic Department and Medical College of Georgia Craniofacial Center; Dr. Abreu is Instructor, Oral Rehabilitation Department; Dr. DeLeon is Goldstein Chair of Orthodontics and Postgraduate Program Director; Dr. Looney is Professor, Departments of Biostatistics and Oral Health and Diagnostic Sciences; Dr. Stockstill is Associate Professor, Orthodontic Department and Director of Orthodontic Research; and Dr. Weiler is Orthodontic Resident, Medical College of Georgia, Augusta, Georgia. Dr. Santiago is Clinical Professor, Department of Orthodontics, School of Dentistry, University of North Carolina, Chapel Hill, North Carolina. Received October 2008; Accepted December 2008. Address correspondence to: Dr. Daniel Levy-Bercowski, 1120 15th Street, School of Dentistry, Department of Orthodontics, Medical College of Georgia, Augusta, GA 30912-1230. E-mail dbercowski@mcg.edu. DOI: 10.1597/07-236.1 521

the interdisciplinary team to improve and maintain adequate nasolabial aesthetics after the primary lip/nasal surgery in children with unilateral and bilateral CL/P (Bennun et al., 1999; Maull et al., 1999; Cho, 2001; Grayson and Cutting, 2001; DaSilveira et al., 2003; Lee et al., 2004; Liou et al., 2004; Suri and Tompson, 2004; Doruk and Kilic, 2005; Singh et al., 2005; Baek and Son, 2006; Spengler et al., 2006; Singh et al., 2007). Clinical goals of NAM include alignment and approximation of the alveolar segments, symmetrical contouring of the nasal cartilages, effective retraction of the protruded premaxilla and lengthening of the deficient columella (Grayson and Santiago, 1997; Cutting et al., 1998; Gateno, 2005; Singh et al., 2005; Spengler et al., 2006; Ezzat et al., 2007; Singh et al., 2007). Complications associated with NAM therapy may increase treatment time and could compromise the final aesthetic treatment outcome. Unfortunately, these complications are minimally considered in the current literature (Grayson et al., 1999). The purpose of the present article is to classify and describe complications that may be encountered during NAM therapy and to prescribe preventive measures and practical solutions. We also provide estimates of the incidence of each complication, based on a series of 27 patients with complete unilateral cleft lip and palate seen by the first author (D.L.-B.). NASOALVEOLAR MOLDING COMPLICATIONS Based on clinical experience, practice, and an intense review of the current literature, three main categories of

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complications associated with NAM therapy have been described: soft tissue, hard tissue, and compliance related. The etiology of each condition will be discussed, followed by a description of preventive or definitive solutions. Soft Tissue Complications Intraoral soft tissue complications involve mucosal ulceration, bleeding, tissue fungal infections, and tissue irritation. Ulcerations may be caused by uneven flanges or underrelieved areas on the intaglio surface of the molding plate. Ulceration also may occur as a result of excessive activation of the internal surface of the appliance, resulting in the impingement of the maxillary mucosa (Grayson et al., 1999). In the bilateral molding plate, the hard acrylic on the internal palatal surface should not extend into the nasal cavity, so as to prevent nasal septum irritation. This septum irritation can be avoided by blocking out the nasal septum on the plaster model prior to appliance construction. If painful spots develop, they can be resolved either by lubricating the mucosal interface or by smoothing rough surfaces and relieving overcontoured areas. Irregular and rough surfaces on the acrylic plate may also cause intraoral bleeding. Caregivers/parents must recognize these lesions early by regularly monitoring the mucosal surface in order to immediately alert the clinician of any unexpected changes in the oronasal tissues. The health care provider must be very careful and methodical during appliance fabrication, ensure adequate appliance insertion, and constantly monitor soft tissue adaptation at every appointment. The NAM appliance is most effective with full-time wear. This full-time wear and contact with the oral microflora provides a potential reservoir for infectious organisms. If the molding plate is not removed daily and cleaned regularly, a candidal infection may result (Andlaw and Rock, 2007). Fungal infestation is treated with Nystatin or Amphotericin ointment. NAM therapy should continue during treatment of the infection until it is resolved. NAM therapy may be further complicated when extraoral surgical tape is used to align alveolar segments and approximate the lip segments. This tape tends to irritate facial epidermal tissues, especially in the zygomatic process areas (Fig. 1A). Parents/caregivers must remove the appliance once or twice a day for proper hygiene and maintenance. The constant removal of the facial tape is a significant factor in the development of contact dermatitis. The rash-like area of erythema and chafing also may result from an intrinsic patient reaction to the tape (Breternitz et al., 2007). Although these lesions are typically self-limiting after surgery when the tape is no longer needed, they must be managed during active NAM therapy to ensure patient comfort and compliance. The application of base or protective tape such as Duo-DERM-ConvaTec directly to the cheeks is indicated in this case. Base tape remains affixed to the cheeks for 4 to 5 days. During this time, the

FIGURE 1A Contact dermatitis due to repeated removal of the tapes. Protective tapes are used to avoid tissue irritation. FIGURE 1B Same patient after 2 weeks of using the protective tape in different areas of the cheeks. Recovery of the tissue is evidenced.

protective tape greatly reduces the amount of cheek tissue irritation normally created by retraction and horizontal tape (Fig. 1B). Additionally, the overlying retraction and horizontal tape must be removed once a day (usually at bath time) and hydration cream should be applied to the cheeks. Each time the base tape is changed, the position of the horizontal and retraction tape on the patients face may be varied, allowing underlying epidermal tissue to ventilate. Nasal soft tissue complications include creation of a mega-nostril, impingement of nasal epithelium, and columellar tearing and bleeding. Mega-nostril is the distended nasal aperture created from excessive tension on the flexible lower nasal alar cartilage (Fig. 2) (Yang et al., 2004). This phenomenon may occur due to improper stent positioning or nasal overcontouring such that stent activation forces are concentrated on the alar rim rather than in the nasal dome (Fig. 3) (Pai et al., 2005). In addition, when the stent is properly positioned in the dome but overactivated, soft tissue impingement may be seen externally as bruising or petechiae in the area of insult. Improper modification of the nasal stent often is caused by the caregiver/parent, who attempt to alter the appliance on his/her own in order to accelerate treatment. Activation and modification of the

Levy-Bercowski et al., COMPLICATIONS AND SOLUTIONS IN NAM 523

FIGURE 2 Mega-nostril produced by improper positioning of the nasal stent.

FIGURE 4 Overstretching of the columella in a patient with bilateral cleft, as a result of the pressure exerted by the prolabium tape and the nasal stents.

stent must be performed in a clinical setting by a qualified practitioner. In both unilateral and bilateral clefts, bleeding may occur during NAM therapy for many noniatrogenic reasons, including patient trauma due to forceful and erratic movements of the head and hands during infancy. Bleeding in patients with unilateral cleft is due primarily to a rough nasal stent and is less frequent and severe than in patients with bilateral cleft, in which overstretching of the thinner columella may occur (Fig. 4). In these cases, the pressure exerted by the prolabium tape and the excessive superior and lateral forces from overactivated nasal stents can exceed tissue thresholds, leading to tearing at the base and resulting in associated bleeding. Extreme care must be applied during activation of stents and prolabium tape to avoid overloading the columellar tissue. Bleeding caused by a rough stent in unilateral cases may be alleviated by deactivating the stent for approximately 1 week to allow for tissue recovery, at which time the stent is reactivated with reduced force. If columellar tissue breaks in a bilateral cleft patient, treatment is suspended for 1 to 2 weeks (depending on the degree of tissue damage) until the tissue heals. 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 (Fig. 5A

FIGURE 3 Overactivation of the nasal stent may produce bruising or petechiae in the dome area.

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FIGURE 5A Patient with complete unilateral cleft lip and palate with a severe nasal deformity (pretreatment with NAM). FIGURE 5B After 18 weeks of NAM treatment, nasal morphology improved significantly. However, a T-shaped maxillary arch was created.

FIGURE 6A Premature eruption of primary maxillary incisors due to the pressure exerted by the molding plate in a patient with bilateral cleft lip and palate. FIGURE 6B Patient continues with NAM treatment after the extraction of the primary incisor.

and 5B). Once again, 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. Adequate approximation of alveolar segments is crucial so that a successful gingivoperiosteoplasty may be performed at the primary surgery of the lip. If this T-shaped configuration is not improved at the neonatal stage, maxillary expansion and a secondary bone grafting procedure will be needed during the mixed dentition stage. Difficulty retaining the device during infancy is another

reason for orthopedic arch expansion at a later stage of growth. The arch shape may be improved when expansion occurs during the mixed dentition stage. An additional complication of the hard tissues involves the premature eruption of primary maxillary incisors through overlying gingival tissue as a result of the pressure exerted by the molding plate (Ziai et al., 2005). A previous study suggested that if the erupting tooth is ectopic or supernumerary, extraction is indicated to prevent aspiration (Fig. 6A and 6B) (Grayson et al., 1999). Extraction is also indicated if the erupting tooth is mobile or interferes with proper activation of the appliance. If the tooth is

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FIGURE 7 NAM modification was done to permit the eruption of the primary upper incisor. FIGURE 8 Arm restraint device is used to prevent removal of the appliance.

erupting in the proper position and orientation, the NAM appliance can be modified either by removing acrylic in the area of eruption or by not intervening at all (Fig. 7). Compliance Complications As with any orthodontic treatment, broken appointments 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 timeconsuming to the families, in some cases requiring hours of travel to craniofacial centers each week and extended time spent in the waiting area. Successful therapy involves a considerable commitment on the part of parents/caregivers. They must be properly educated and motivated about NAM treatment, and audiovisual aids should be used to thoroughly inform the decision makers of the risks and potential benefits related to NAM therapy. The parents/ caregivers may greatly benefit by seeing previously treated patients and by sharing treatment experiences with other families. Ultimately, the caregivers/parents must approve treatment by signing an informed consent prior to initiating treatment. To assure proper activation and stability of the NAM device, the retraction tape is directly attached to the appliance and adhered to the base tape on the cheeks under slight tension. When used in combination with tapes, liquid adhesives may enhance the retention of the tapes and improve the stability of the appliance. Without question, when tapes and elastics are not properly applied, critical progress will be delayed or lost (Grayson et al., 1999). Parents/caregivers have the primary responsibility for maintaining proper positioning and activation of the appliance and for ensuring that it is adequately cleaned. Failure to properly perform this duty may lead to long periods of dislodgement and inactivation, during which time the cleft gap may be maintained as the patient places the tongue into the defect. In addition to caregiver/parent compliance, patient behavior is critical to the success of NAM. As the infants

neuromuscular system matures during the months of presurgical orthopedic treatment, the child becomes more prone to appliance removal by his/her hands or tongue. Arm restraints can be used to prevent the patients limb movements toward the mouth (Fig. 8). If the infants tongue continues to dislodge the appliance, the clinician should try to extend the acrylic molding posteriorly until a gagging reflex is elicited. It is then slightly shortened until the reflex disappears. By lengthening the device, the posterior border is placed out of the reach of the tongue (Fig. 9A and 9B). If after the appliance has been lengthened, the child continues to remove the device with his/her tongue, the surgeon should proceed with the primary surgery. METHODS AND MATERIALS Data were collected retrospectively from the charts of 27 patients with complete unilateral cleft lip and palate, treated by the first author (D.L.-B.) at the University of Puerto Rico (n 5 12) and the Medical College of Georgia (MCG) (n 5 15). Informed consent and institutional review board (IRB) approval were obtained for the University of Puerto Rico patients. Informed consent and Health Insurance Portability and Accountability Act clearance were obtained for the MCG patients, and IRB protocol was waived for the use of MCG data and photographs. Confidence intervals for the true incidence of each complication were calculated using exact methods based on the binomial distribution. The Fisher-Freeman-Halton exact test with mid-P correction was used to examine the association of the incidence of each complication with race and with gender. The point biserial r was used to measure the association of the incidence of each complication with patient age and with time of treatment. Summary statistics are given as mean 6 standard deviation. A significance level of .05 was used for all statistical tests.

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TABLE 1

Complications in Presurgical NAM Therapy (N = 27)*

95% LCL (%) 95% UCL (%)

Complication

n Percentage

Soft tissue Mucosal ulceration Intraoral bleeding Tissue fungal infections Tissue irritation Mega-nostril Impingement of nasal epithelium Nasal bleeding Hard tissue Asymmetric T-shaped arch Compliance issues Broken appointment One or more Removal of NAM appliance by tongue Removal of NAM appliance by hands

2 2 2 20 2 2 1 2

7 7 7 74 7 7 4 7

1 1 1 54 1 1 0 1

24 24 24 89 24 24 19 24

8 7 3

30 26 11

14 11 2

50 46 29

* LCL 5 lower confidence limit; UCL 5 upper confidence limit.

treatment was begun was 4.2 6 2.0 weeks, with a range from 1 to 10 weeks. Treatment was suspended for two (7%) of the patients, one due to a family crisis and the other due to multiple medical complications. The mean treatment time for the 25 patients who completed treatment was 16.6 6 3.7 weeks, with a range from 10 to 20 weeks. Data on NAM complications were collected from all 27 patients, including the two for whom treatment was suspended. Both of these subjects experienced tissue irritation and removed the NAM with both their tongue and their hands prior to suspension of treatment. Soft Tissue Complications With the exception of tissue irritation, which occurred in 20 (74%) of the patients, none of the soft tissue complications described above occurred in more than two patients (Table 1). Eight (30%) of the patients had two soft tissue complications, one (4%) had three complications, but none of the patients had more than three complications. None of the patients had columellar tearing.
FIGURE 9A Utility wax added to the posterior portion of the appliance to act as a tray for additional acrylic. FIGURE 9B After rebase with hard acrylic, the molding plate was lengthened to improve retention and avoid being dislodged by the tongue.

Hard Tissue Complications An asymmetric T-shaped arch occurred in 2 (7%) of the 27 patients (Table 1). None of the patients had premature tooth eruption during the study period. Compliance Complications

RESULTS Demographics Seventeen (63%) of the 27 patients were white, seven (26%) were Hispanic, and three (11%) were African American. Twenty (74%) of the patients were boys and seven (26%) were girls. The mean age at the time NAM Eight (39%) of the patients had at least one broken appointment (Table 1). The number of broken appointments ranged from 1 to 5 with a mean of 3 6 1. The NAM appliance was removed with the tongue in seven patients (26%) and with the hands in three (11%) (Table 1).

Levy-Bercowski et al., COMPLICATIONS AND SOLUTIONS IN NAM 527

Risk Factors for Complications There were no significant associations between the demographic characteristics (race, gender, and age at initiation of NAM therapy) and any of the complications described above. The same was true for the association between time of treatment and each of the complications. DISCUSSION Minimal literature is available for comparison of the present data with previous studies. In 1999, Grayson described some of the complications caused by the use of the NAM technique, which included soft tissue breakdown, intraoral ulcerations, failure to apply tapes and elastics, cooperation issues, and the eruption of a neonatal tooth during the treatment. In our study, a classification of the possible complications is presented, including soft tissue, hard tissue, and compliance complications in order to prescribe preventive measures and practical solutions for their management. We also provide estimates of the incidence of each complication based on a series of 27 patients with complete unilateral cleft lip and palate, seen by the first author (D.L.-B.). Most of the complications of NAM therapy considered in this article had a very low estimated incidence based on the series of 27 patients. Of the soft tissue and hard tissue complications, only one soft tissue complication (tissue irritation) had an estimated incidence greater than 10%. The upper limit of the 95% confidence interval for the remaining soft tissue and hard tissue complications was 24% or less. Compliance issues were of greater concern, with an estimated incidence of broken appointments of 30% (upper confidence limit, 50%) and an estimated incidence of removal of the NAM appliance by the tongue of 26% (upper confidence limit, 46%). All the complications that involve soft and hard tissues can be managed by the clinician without there being a need to suspend treatment. Compliance of the patient and caregivers/parents with all treatment recommendations is the key factor in developing a successful outcome and reducing the possibilities of any negative sequelae associated with this congenital deformity. In our study, we suspended NAM treatment in two cases due to one patient having a family crisis and the other patient experiencing acute, multiple medical complications. CONCLUSIONS Presurgical nasoalveolar molding therapy has proven to be an effective orthopedic treatment alternative for infants born with CL/P. When applied, it facilitates primary surgical cleft lip/alveolar repair and improves the clinical result. Although the benefits outnumber the complications, it is important to address all complications in order to prevent any deleterious outcomes. These complications

involve oral and facial soft tissues and intraoral hard tissues, as well as patient and caregiver/parent compliance. Although soft tissue irritation is the most common tissue complication, compliance issues were of greater concern. These problems may delay the achievement of the proposed treatment goals and could compromise a successful outcome. Simple solutions have been provided in order to prevent occurrence of these complications and to resolve them if they do occur. Most of these complications are operator-dependent and will be minimized and properly resolved with experience. Due to the limited time frame allowed to successfully apply NAM therapy, it is crucial to avoid any complication in order to achieve adequate functional and aesthetic results.

Acknowledgments. The authors extend their sincere gratitude to Patricia Hall, M.S., for her contribution with the data analysis and Jack Yu, M.D., for his editorial contribution.

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