Presurgical Orthopedic Therapy for Cleft Lip and Palate

Background

In presurgical orthopedic therapy, orthodontic techniques are used to mold the maxillary, alveolar, and nasal tissues of an infant with a unilateral or bilateral cleft lip and palate. ^[1] Other terms used for these techniques are neonatal infant orthopedics, presurgical infant orthopedics, and nasal-alveolar molding. ^[2] Because the infant does not yet have teeth, the term orthodontics would be inaccurate; thus, orthopedics is the preferred term.

The use of presurgical orthopedic therapy is widespread; 47-51% of neonates treated for cleft lip and palate in the United Kingdom have presurgical appliances. ^[3] In the United States and Canada, 71% of centers reported using some form of presurgical molding before bilateral cleft lip surgery, with nasoalveolar molding being the most popular at 55% of those using this treatment. ^[4]

Two categories of appliances are used: passive and active. Active appliances are fixed intraorally and apply traction through mechanical means such as elastic chains, screws, and plates. ^{[5, 6]} Passive appliances maintain the distance between the 2 maxillary segments while external force is applied to the primarily to reposition it posteriorly. The nasoalveolar molding device (see the image below) is a very elaborate passive device; it consists of an intraoral acrylic plate held in place with extraoral elastics and tape. In later phases of treatment, wire outriggers are added that apply protracting force to the vestibule of the nares, lengthening the columella. ^[7]

External force can be applied by external taping of the lip, a head cap with elastic straps across the prolabium, or a surgical lip adhesion. ^[7] See the image below.

Presurgical orthopedic devices are a controversial topic in cleft treatment. Arguments against their use include the potential for long-term growth effects and potential feeding difficulty. ^{[8, 9]} With increasing clinical experience, the long-term outcome and the specific role of presurgical orthopedics are becoming better defined. ^{[10, 11, 12, 13, 14]} Empirically, molding can narrow the width of clefts and make subsequent surgery less technically demanding. The long-term outcomes of individuals treated with this protocol will determine its future acceptance.

Indications

Indications for the use of presurgical orthopedic therapy are evolving. Advantages include the following:

• Improvement in soft tissue form, reducing the need for surgical dissection ^{[15, 16]}

• The ability to perform either primary bone grafting or gingivoperiosteoplasty, which could potentially reduce the need for secondary bone grafts ^{[17, 18, 19]}

• The potential for improved feeding efficiency owing to cleft narrowing and obturation; Masarei et al, however, found that presurgical orthopedic therapy did not improve feeding efficiency in treated infants ^[20]

Contraindications

Contraindications include a lack of family and patient compliance or acceptance of the device.

Outcomes

Several large case control studies have demonstrated adverse outcomes in protocols using active presurgical orthopedic therapy. Henkeland and Gundlach reported that the Latham-Millard active orthopedic device had an adverse effect on facial growth. ^[21] Berkowitz reported worsened occlusal outcomes in the patients treated with the Latham-Millard device. ^[22] Matic and Power found maxillary growth to be decreased after active presurgical orthopedic therapy in unilateral and bilateral clefts, respectively. ^{[23, 24]} They also found that almost all patients treated with gingivoperiosteoplasty or primary bone graft also required secondary bone grafting.

Studies of passive-treatment presurgical orthopedic therapy have shown a more mixed outcome. Wood et al reported that the passive nasoalveolar molding device and primary gingivoperiosteoplasty did not cause an unfavorable effect on facial growth. ^[25] For patients treated with a nasoalveolar molding device and a primary gingivoperiosteoplasty, Santiago et al reported a reduced need for secondary alveolar bone grafts. ^[26] Shetty et al, however, found better outcomes in patients on whom the nasoalveolar molding treatment had begun within 1 year of life, as opposed to those in whom treatment began later. ^[27]

Preoperative treatment with nasoalveolar molding seems to improve results of nasal shape, especially in bilateral clefts. ^[28] Garfinkle et al presented a series of patients with bilateral cleft lip and palate treated with a nasoalveolar molding protocol who required no further intervention for nasal reconstruction beyond their initial repair. ^[29] Nazrian-Mobin et al found that nasoalveolar molding improved the nasal columnar length and width much better in patients with bilateral clefts than in those with unilateral clefts. ^[30]

Bongaarts et al reported on results from the multicenter Dutch cleft experience; they found that presurgical orthopedic therapy with a passive acrylic plate similar to the nasoalveolar molding system showed no improvement in occlusal outcomes. ^[31] Uzel and Alparslan published a meta-analysis of 8 randomized controlled trials and 4 case-controlled trials with presurgical orthopedic therapy appliances; they found no long-term positive effects on the studied treatment outcomes in patients with cleft lip and palate. ^[32] Van der Heijden et al in a meta-analysis of 12 studies of presurgical orthopedic treatment of unilateral cleft lip found inconsistent results on nasal symmetry. ^[33] Both authors of the meta-analyses concluded that studies were heterogeneous and more randomized controlled trials are needed to evaluate the effects of different surgical protocols.

Relevant Anatomy

The lips surround the entrance to the oral cavity. The upper lip extends from the base of the nose superiorly to the nasolabial folds laterally and to the free edge of the vermilion border inferiorly. The lower lip extends from the superior free vermilion edge superiorly, to the commissures laterally, and to the mandible inferiorly. Around the circumferential vermilion-skin border, a fine line of pale skin accentuates the color difference between the vermilion and normal skin. Along the upper vermilion-skin border, 2 paramedian elevations of the vermilion form the Cupid bow. Two raised vertical columns of tissue form a midline depression called the philtrum. The philtrum is located between the paramedian elevations of the vermilion and the columella above.

The oropharynx is the middle part of the pharynx directly below the soft palate that communicates anteriorly with the oral cavity proper by the isthmus of the fauces, also known as the oropharyngeal isthmus. Specifically, the oropharyngeal isthmus is bound superiorly by the soft palate, laterally by the palatoglossal arches, and inferiorly by the posterior third of the tongue. The most prominent feature of the oropharynx is the two folds that are termed the pillars of the fauces, the palatoglossal arch and the palatopharyngeal arch. The palatoglossal arch contains the palatoglossus muscle and travels anteroinferiorly from the soft palate to the lateral aspect of the tongue.

For more information about the relevant anatomy, see Lips and Perioral Region Anatomy and Pharynx Anatomy. Also see Nasal Anatomy, Mouth Anatomy, and Facial Bone Anatomy.

Pre-Procedure Planning

Children with cleft deformities require a multidisciplinary approach to reconstruction. A team approach to treatment is the standard of care. Close cooperation of the surgeon with the orthodontist is necessary to achieve desirable outcomes with presurgical orthopedic therapy.

Complications

The major controversies in the use of presurgical orthopedic therapy are the potential for primary bone grafting or gingivoperiosteoplasty to cause the following:

• Growth retardation and subsequent maxillary retrusion

• Worsened occlusal relationships

Complications related to the specific devices include the following:

• Feeding difficulties

• Skin irritation from tape

• Pressure ulceration of the gingival mucosa

• Possible of airway obstruction from a misplaced intraoral device

Presurgical Phase

The presurgical phase involves the application of the device, activation of forces, and treatment adjustments.

In passive appliance protocols, deformational forces are transmitted through soft tissue. Tape adhesion may be used as an initial or as a complete treatment. Tape is applied to the infant's cheeks with some traction directed toward closing the cleft gap. A base layer of tape may be used on the cheeks in order to prevent traction blisters. Tapes are replaced by parents daily or more often, keeping a constant deformational force closing the cleft gap.

In the nasoalveolar molding ( NAM) protocol, an acrylic plate is placed intraorally to effect alveolar and nasal molding. In order to fashion the plate, a maxillary impression must be made. This can be performed in the office or in a procedure room if proper equipment is available to safeguard the infant's airway. Once the intraoral plate is fashioned, it is stabilized in the infant's mouth with tapes or elastics secured to base tapes on the child's cheeks, similar to those used in tape adhesion technique. The acrylic plate is adjusted in the orthodontic clinic on a weekly basis, with acrylic added in areas to create pressure on the tissue and removed in areas where the tissue is expected move. Choo et al presented a modification for treatment of bilateral cleft in which the premaxilla was excluded from the plate and the lateral segments alone were treated. ^[34]

In active appliance protocols, such as that of Latham, the deformational forces are transmitted directly to bone via trans-mucosal pins. ^[35] As such, the appliance must be secured in the operating room. Once placed, adjustments are made by turning a traction screw on the appliance.

Cleft Lip Repair

Surgical cleft lip repair reestablishes the soft tissue and muscular forces on the easily moldable maxillary arch segments. Two categories of appliances are used, passive and active.

Passive appliances maintain the distance between the 2 maxillary segments while external force is applied to encourage posterior repositioning. This external force can be external taping, a head cap with elastic straps across the prolabium, or even a surgical lip adhesion. See the image below.

Active appliances are fixed intraorally and apply traction through mechanical means such as elastic chains, screws, and plates.

For bilateral clefts, external pressure is often used to help maintain the premaxillary component within the arch alignment. Soft elastic tape across the premaxilla, a head cap with elastic traction, or lip adhesion have been used prior to a definitive lip repair once the arch segments have approximated. See the images below.

Cleft Nasal Repair

The palatal appliance may be modified to include a nasal extension to help improve the nasal tip form.

Operative Phase

Surgeons must alter their surgical techniques to optimize the advantages offered by presurgical orthopedic therapy. Details are provided in Bilateral Cleft Lip Repair and Bilateral Cleft Nasal Repair.

When presurgical orthopedic therapy is used to convert a wide cleft into a narrower one, less dissection and hence less surgical trauma will be necessary. More controversially, there is potential with the narrower cleft to perform primary bone graft or a gingivoperiosteoplasty.