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 Table of Contents  
Year : 2022  |  Volume : 9  |  Issue : 1  |  Page : 101-109

Presurgical infant Orthopedics: A developmental and clinical evolution

1 Director, Post-Graduate Board of Studies, Department of Orthodontics and Dentofacial Orthopedics, Manav Rachna Dental College, Faridabad, Haryana, India
2 Associate Professor, Department of Dental Surgery and Oral Health Sciences, AFMC, Pune, India
3 Consultant Orthodontist, Private Practise, Delhi, India

Date of Submission10-Nov-2021
Date of Acceptance16-Nov-2021
Date of Web Publication01-Jan-2022

Correspondence Address:
Dr. Puneet Batra
Department of Orthodontics and Dentofacial Orthopedics, Manav Rachna Dental College, Faridabad, Haryana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jclpca.jclpca_40_21

Rights and Permissions

The cleft lip and palate (CLP) anomaly involves treatment right from birth till adulthood. A lot of treatment modalities are also time and age sensitive, that if not performed at the correct time, the results are sub-optimal or compromised. One such treatment modality is Presurgical Infant Orthopaedics (PSIO) which is among the first corrective and therapeutic procedures performed in the infants with CLP anomaly. The role of an orthodontist is pivotal in guiding the two cleft segments into a relatively normal position before the surgical repair is performed. Over the course of history, this procedure has seen many modifications, arguments over its utility, and counter arguments of the potential harms. The present articles shed light over the initial inception of the procedure, its development and improvement, long-term changes seen in the patients treated with PSIO technique, and finally the latest advancements in technique.

Keywords: Aligner nasoalveolar molding, DynaCleft, nasoalveolar molding, presurgical infant orthopaedics

How to cite this article:
Batra P, Datana S, Arora A. Presurgical infant Orthopedics: A developmental and clinical evolution. J Cleft Lip Palate Craniofac Anomal 2022;9:101-9

How to cite this URL:
Batra P, Datana S, Arora A. Presurgical infant Orthopedics: A developmental and clinical evolution. J Cleft Lip Palate Craniofac Anomal [serial online] 2022 [cited 2022 Oct 2];9:101-9. Available from: https://www.jclpca.org/text.asp?2022/9/1/101/333653

  Introduction Top

Cleft lip and palate (CLP) is one of the most common congenital birth defects of the craniofacial region caused due to the discrepancy in gestational development of facial structures. The patients with CLP are seen to present themselves with an array of structural deformity from asymmetrical vermillion border, nasolabial anomaly, deviation of nasal septum, and a deficient maxilla to functional difficulties in speech.[1],[2],[3],[4]

The management of the patients with CLP anomaly begins right after the birth of the baby with presurgical infant orthopedics (PSIO). This procedure uses the principle that maternal estrogen levels are high in the infants giving neonatal tissues elastic and moldable properties at birth. The maternal estrogen levels decrease rapidly after 4 months which may prevent effective tissue molding at a later stage. PSIO is performed with the objective to reduce the gap between the two cleft segments, so as to achieve a favourable alignment in the cleft segments in the infancy period before primary lip repair (cheiloplasty), thereby allowing ease in surgical repair with minimal tension.[4]

  Historical Perspective Top

Since the 1950's in Europe and the United States, the ideas of McNeil, have been considered as fundamental. However, PSIO appliances have been a part of early intervention of patients with CLP deformity before the technique was popularized. The technique has seen a wide array of evolution from McNeil's concept of alveolar molding to the concept of nasoalveolar molding (NAM). [Table 1] briefly describes the evolution of the PSIO appliances from its early inception.
Table 1: Evolution of PSIO appliances

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  Objectives of Presurgical Infant Orthopaedics Top

The concept of PSIO works on Matsuo's principle, that due to the increased levels of maternal oestrogen, the infant cartilage is mouldable. The primary objective of PSIO has been the approximation of the minor and major segments to facilitate the surgical repair and minimal tissue stretch. The secondary objectives include stimulating palatal shelf growth, upper arch development, improving in the nasal projection leading to overall growth of the nasolabial region and face.[15],[16],[17],[18],[19]

Reshaping of the deformed alar cartilage and stretching of the nasal mucosa enhances the surgeons' ability to achieve a good surgical repair.

The duration of molding therapy varies depending on the clinical objectives and the severity of the cleft deformity, however, it has been observed that bilateral cleft patients tend to take one to two additional months to achieve the clinical objectives.

  Classification of Presurgical Infant Orthopaedics Appliances Top

PSIO appliances have been broadly classified based on method of force application [Table 2]. Active appliances are the one in which the desired anatomic position of alveolar processes is achieved by active force application on the alveolar processes, whereas the passive appliances use study model for construction of appliances onto the alveolar processes, following which clinician uses flowable acrylic for addition or remove acrylic from the appliance, in a process called “negative sculpting.” This results in providing shape to the alveolar processes and make them grow passively as planned by the clinician.[15]
Table 2: Classification of presurgical infant orthopaedics appliances [PSIO]

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Latham appliance

Georgiade and Latham refined the technique of McNeil appliance and developed an apparatus named Mark III.

The appliance aligns the segments of cleft through rapid orthopedic correction.[9],[20] It is an active pin retained appliance requiring surgical intervention at an age of 2–5 month. This appliance worked by simultaneous application of pressure to the cleft segments over a 4–6-week period. The alveolar segments gradually move to the proper position and was followed by gingivoperiosteoplasty and lip adhesion.

Initially, the appliance was restricted to be inserted only in babies with bilateral cleft with total collapse of the lateral palatal segments and a severely protruding premaxilla. However, studies have shown a high frequency of anterior as well as a posterior cross-bite as a side effect occurred more frequently with Latham appliance usage.[21]

Hotz appliance

In the mid-1950s based on the treatment principles of McNeil, neonatal maxillary protocols began in Zurich. It was also noted that the use of active force was not desirable and consequently, the procedure was greatly modified to be known as the “Zurich approach”.

In accordance, the primary objective of PSIO was not only to facilitate surgery or stimulate growth as was initially postulated by McNeil, but to take advantage of the intrinsic development potential. “The Hotz appliance” was a passive plate made of soft and rigid acrylic that was used 24 h a day approximately from 16 to 18 months. Arch alignment is achieved by selectively grinding away the acrylic in specific areas.[22] Subsequent evaluation revealed better results, with the width of the palate was larger in the Hotz plate group than in the control group. Silvera et al. compared the two-stage palatoplasty in combination with Hotz plate with one stage palatoplasty with Hotz plate and found good effects on the maxillary growth with the former approach up to the age of 12 years.[23]

Thus, the three important aspects in relation to food and function of the Hotz plate:

  1. To close the fissure and the lip and achieve a good contact with the mother's breast
  2. Close the cleft of the hard palate
  3. Provide a positive contact between the tongue and posterior palate.

Naso alveolar molding

Grayson[14],[24] introduced a new technique of molding the lip, alveolus, and nose in infants born with CLP based on Matsuo's principle.[11] Grayson and cutting (1988) combined the concept of presurgical orthopedics and nasal deformity and developed the concept of PNAM (Presurgical NAM), which used a nasal molding stent with a passive alveolar molding appliance. The major advantages of NAM include improvement in arch form, facilitation of surgical closure and thereby improvement of esthetic outcome, facilitation of feeding, and improvement of speech. In Bilateral CLP patients, an additional objective of centralization and retraction of the protruding premaxillary segment is achieved with the help of the appliance.

Presurgical orthopedics reduced the extent of surgical correction required for the lip and nasal repair, and there is less tension on the reconstruction, theoretically resulting in more predictable reconstructive results.[2],[3],[14],[19],[24],[25],[26],[27],[28],[29]

Lip taping

Extraoral tapes have also been used to bring the two lip segments together in conjunction with the molding plate and nasal stent. Taping the lips improves the relation of lower mid-face skeletal as well as an improvement in the overlying soft tissue. The stretched alar rim over a wider alveolar cleft base shows laxity and becomes enable to be more convex and symmetrical in form. Furthermore, the nasal tip on the cleft side is overcorrected in its forward projection with the help of nasal stent and surgical tapes.

Proposed benefits of nasoalveolar molding[2],[14],[24],[25],[26],[27],[28],[29],[47]

  1. Alignment of lip, nose, and alveolus and approximation of the minor and major segments enabling surgeons for better surgical repair and hence reduce post-surgical breakdown. It results in less scar formation and proviades better lip and nasal form
  2. Reduces the number of surgical revisions for excessive scar tissue, oronasal fistulas, nasal and labial deformities, due to proper columellar elongation and lengthening
  3. Creating favorable environment by increasing the bony support thus enabling the spontaneous eruption of the permanent teeth in good position and with adequate periodontal support
  4. Maxillary growth augmentation for better feeding and elimination of nasal regurgitation
  5. Reduced psychosocial impact and better parent compliance.

Clinical procedure

Infant impression

The primary impression of the patient with CLP is obtained within the 1st week after the birth. The commonly used materials for recording the impression include alginate, low fusing impression compounds, polyvinyl siloxane, heavy body silicon, cottonoid patties, ZOE pastes, and waxes. The rubber base impression materials is the preferred material of choice in comparison to other materials due to its ease of manipulation, good tear strength, controlled setting time, and accuracy [Figure 1]a.
Figure 1: (a) Heavy bodied silicone for initial impression recording, (b) Customized tray for recording the impression, (c) Head on knee position during impression recording

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Steps in infant impression

  1. The clinical exam of patients with CLP is done and checked for cleft defects, natal teeth, Simonart's band, unusual undercut, and other tissue abnormalities
  2. Customized impression trays are selected over stocked trays. The trays should be large enough transversely, so as to include lateral segments of maxilla, posteriorly to cover tuberosities. The accurate reproduction of muccobuccal mucobuccal folds depends on selection of trays [Figure 1]b
  3. Positioning of infant patients with CLP is of critical importance. A number of positions have been adopted, which include prone, face down, upright, inverted upside down, and horizontal. Supine position with head down is the most preferred position [Figure 1]c Fluids should also be drain out of the oral cavity and prevent the tongue from falling back. Furthermore, the infant vitals and belly are constantly monitored for SpO2 and any signs of hyposis
  4. The impressions for PSIO appliances should be preferably taken in a hospital setup so as to counter any airway emergency if arises
  5. The tongue is depressed using mouth mirror, cotton tipped ear buds are used to cleanse the infant oral cavity. The infants are fully awake without any anesthesia or premedication. Infants should be able to cry during the impression procedure and any absence of crying may indicate blockage of airway
  6. A finger may be used to clear excess material. High-volume suction should be nearby for any assistance related to regurgitation of contents
  7. Preferably, infants should not have been fed in the past 2 h before impression recording
  8. The infant is made to lie on supine position on lap of parent with head on knees at a lower level. The doctor positions himself in 10 o'clock position to infants head
  9. The trays are ensured for smooth borders, followed by use of fast setting putty material. The impression is recorded with utmost care in above mentioned specified position
  10. The positioning is mobile pre maxillary segment is necessary in case of infants with BCLP
  11. Monitoring of infants oxygen level is done throughout the impression recording procedure so as to prevent accidental hypoxia.

Complications in impression recording

There are various complications that are associated with impression recording of patients with CLP. It is mainly due to the fact that infants are obligatory nasal breathers. The complications include difficulty in withdrawal of impression due to the engagement in nasal cavity undercut/improper impression material, cyanosis due to flow of impression material through cleft, foreign body aspiration, gagging, and choking. The relief manoeuvres include back blows, chest thrusts, and finger sweeps. Rescue breathing should be attempted in case of emergency.

Appliance fabrication and design

The dental stone model is made using the impression taken [Figure 2]. All the undercuts and the cleft space on the model are blocked out with the wax. The molding plate is made up of hard, clear self-cure acrylic. To provide the structural integrity and to permit the adjustments during the process of molding, the plate should be made up of 2–3 mm thickness. The tray should be adequately trimmed to relieve the frenum and other attachments. A retention button is fabricated and positioned at an angle of 40° anteriorly to the plate. Only one retention arm is used in the unilateral cleft [Figure 3]. The exact positioning of the retention arm is decided at the chairside. It should be positioned such that it should not interfere with bringing the cleft lips together. The retentive arm should be positioned vertically at the junction of the upper and lower lip. The orthodontic elastics and tapes should be used to secure the molding plate adequately in the mouth. On the palatal surface of the molding plate, a small opening of 6-8 mm diameter is made to provide an airway if the plate drops down posteriorly. The nasal stent is not fabricated along with the molding plate. The nasal stent is constructed and incorporated into the tray when the cleft of the alveolus is reduced to about 5–6 mm in width [Figure 4].
Figure 2: Elastomeric Impression and dental stone (working model) of patient with CLP

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Figure 3: Moulding Appliance for Unilateral and Bilateral Cleft

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Figure 4: (a and b) Nasal Stent for unilateral cleft and bilateral cleft

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Insertion and taping

The molding plate should be inspected for any sharp edges, overextension, or rough surfaces which may irritate the soft tissue, especially in the area of the vestibular folds as well as the posterior border to the cheek. The appliance is then secured to the cheeks extraorally bilaterally by surgical tapes that have orthodontic elastic bands attached at one end [Figure 5]. To reduce irritation on the cheeks, it is advised to use skin barrier tapes like DuoDerm® Dressing (ConvaTec Inc., UK) or Tegaderm™ Transparent Film Dressings (3M™, USA). The horizontal surgical tapes should have a length of 3–4-inch length and a quarter inch in width. The elastic on the surgical tape is looped on the retention arm of the molding plate and secured to the cheeks by using tape. The elastics with inner diameter 0.25 inch and heavy wall thickness should be stretched approximately two times their resting diameter for delivering an activation force of about 100 g. The amount of force could vary depending on the mucosal tolerance to ulceration and clinical objectives. Additional tapes may be necessary to secure the horizontal tape to the cheeks. Parents or caretakers should be instructed to keep the plate in the mouth full time and to remove it for cleaning daily. The infant may require time to adjust to feeding with the NAM appliance in the first few days.
Figure 5: Cleft lip and palate patient with moulding appliance

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Molding technique

To bring the alveolar segments together, the baby is seen weekly and adjustments are made on the molding plate [Figure 5]. These adjustments are made by selectively adding the soft denture base material to the molding plate and removing the hard acrylic [Figure 6]. Care should be taken to prevent the soft denture material from building up on the height of the alveolar ridge as it will prevent complete seating of the molding plate. The molding plate should not be modified more than 1 mm in one visit.
Figure 6: (a) Moulding technique showing addition of acrylic in blue and removal of acrylic in red (b) Soft reliner material used for moulding

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Incorporation of the nasal stent

When the width of the alveolar gap is reduced to about 5 mm, the nasal stent component is incorporated into the NAM appliance. The rationale behind the delaying of the addition of the nasal stent is that as the alveolar gap is reduced, the base of the nose and the lip segment alignment also improve. The stent is made in the shape of 'Swan Neck' by using round stainless steel of 0.36-inch dimension. To appreciate the correct shape and orientation of the wire stent, a roll of soft wax template is made and seated on the molding plate. The stent is attached to the molding plate on the labial flange, near the base of the retention arm, entering 3–4 mm past the nostril aperture. To create retention to the intranasal portion of the nasal stent, the wire extending into the nostril is curved back on itself to create a small loop. The bi-lobed hard acrylic component is shaped, and a layer of soft denture liner is added. 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.

Columella lengthening in bilateral cleft lip and palate

In bilateral CLP cases, two nasal stents and two retentive arms are similar to that of the unilateral stent incorporated into the molding tray. Unlike the unilateral cases, special attention should be focused on the nonsurgical lengthening of the columella after the incorporation of the nasal stent in bilateral cases. Columella lengthening is achieved by adding a horizontal band of the denture material to join the left and right lower lobes of the nasal stent. This band sits at the nasolabial junction. As the nasal tip continues to be lifted and projected forward, this angle gets defined. The tape is adhered to the prolabium underneath the horizontal lip tape and stretches downward to engage the retention arm with elastics. The vertical pull provides a counter stretch to the upward force applied to the nasal tip of the nasal stent. Taping in the downwards direction on the prolabium helps to vertically lengthen the often-small prolabium and lengthen the columella. The prolabium taping is done before the horizontal lip taping.

Complications of NAM[2],[14],[24],[25],[26],[27],[28],[29]

  1. Locked-out segments occurs due to the poor and un-volunteered molding procedure, wherein the greater segment moves more rapidly, without the change in position of the lesser segment resulting in the lesser segment getting locked behind the greater segment
  2. Nostril overexpansion (Mega-nostrils) occurs when the nasal stent application has been started before the size of the cleft gap is adequately reduced. The premature nasal stenting exerting excessive force against the nasal tissue may result in excessive alar expansion and mega-nostrils
  3. Tissue ulceration – this occurs due to application of pressure by the intra-oral acrylic appliance, which may be due to ill-fitting appliance
  4. Skin ulceration may occur due to repeated application and removing of tape over the cheek region
  5. Failure to retain appliance during NAM therapy – this usually occurs due to poor patient compliance. It may also occur due to poor parent compliance, usually when the parents are uneducated or when the appointments are frequently missed
  6. Dislodgment of the plate may result in obstruction of the airway. This can only occur, if the arms of the appliance are taped too horizontally or with inadequate activation.

Prevention of the complications associated with nasoalveolar molding therapy[2],[14],[24],[25],[26],[27],[28],[29]

  1. The direction of tissue expansion and associated mechanics should be monitored regularly and nasal stenting should be started only after the cleft gap is reduced by minimum 5 mm
  2. Tissue rashes and skin ulcerations can be prevented by use if tissue lubricant over the appliance and use of Duoderm® or Tega-derm™, underneath the tape strapped
  3. Feeding instructions should also be given accordingly and parents are motivated to visit the clinics on scheduled appointments
  4. Over the years, different modification in the NAM technique has been proposed. These modifications are briefly described in the [Table 3].
Table 3: Different modifications in NAM technique

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Figueroa's appliance

The Figueroa's technique involves preformed simultaneous alveolar and nasal molding acrylic plate with rigid acrylic nasal extension. Rubber bands are attached to the acrylic plate for retraction of the premaxilla backward. A soft resin ball is attached to the acrylic plate transversely across the prolabium to maintain the nasolabial angle. Grayson NAM and Figueroa appliance when compared in treated patients with CLP showed similar improvement of nasal deformities and reduction alveolar gaps, however, the less oral mucosal complication and more efficiency was seen with Figueroa appliance.[40]

However, PSIO has been a controversial modality amongst the clinician, academician and researchers. With both school of thoughts providing valid points enumerating pros and cons of the technique [Table 4].
Table 4: Comparison of advantages and disadvantages of PSIO

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Recent modifications

Impression recording using intraoral scanners

The intraoral scanner has been used in recent times in patients with CLP. It captures the cleft anatomy with precision and the data is saved in STL format. Further, the data files are used for the purpose of 3-dimensional (3-D) printing. This virtual method of recording the cleft defect and anatomy using modern technology, helps not only to eliminates the time-consuming complicated cleft impressions but also limits the further complications related to impression recording steps in patients with CLP.[2]

DynaCleft® and nasal elevators

The Dynacleft and nasal elevator system was given by Southmedic, which consists of a sticky tape with a flexible elastic connecting the tape which helps in the approximation of the two cleft segments when the infant makes various oral movements, it also comes with a Nasal elevator which comes in universal size and resembles a hook like shape that helps in elevating the Nostril of the infant at the same time correcting the shape of the depressed dome of the nose. While traditional surgical adhesive tape (e.g. Silk tape, Steri-Strips® 3M™) have been used in the past, unlike tape, DynaCleft® provide a constant approximation force with an elastic center that allows it to conform to a baby's mouth better because of its ability to expand and contract. As the DynaCleft® device is premade, there is no lab cost associated with DynaCleft® therapy.[40],[41],[42]

Prior to DynaCleft, Doruk and Kiliç[31] developed an extraoral appliance which comprised of a nasal stent with a helical spring that extended from the forehead to the chin, supported by a circumferential headband. An intraoral plate was inserted separately for alveolus molding. The limitation of that appliance was its complex design, which could obstruct feeding.

Aligner nasoalveolar molding therapy

In 1997 Align Technology (Santa Clara, Calif) introduced the clear aligner treatment (CAT) as we know it today. With the advent of technological improvements such as intra-oral 3-D scanning, the prospect of performing NAM using CAT was an interesting option especially with regard to comfort and ease of use; as the hazards of impression taking in cleft babies like respiratory obstruction, cyanosis etc., is well-documented in the literature.[43] Aligner NAM was first published towards the end of 2019. These trays are fabricated digitally with the main objective of bringing the cleft segments together in proper alignment, with every tray reducing the cleft gap by 1 mm in sequential appointments and gives proper alignment to the cleft segments. At the same time, the nasal correction is done with the help of a custom-made Elevator made with acrylic to mold the nasal structures to their desired shape [Figure 7].
Figure 7: Patient with nasoalveolar molding Aligner Therapy

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  Conclusion Top

The constrains in the studies related to PSIO include smaller sample size, lack of multicenter studies and different techniques of PSIO, followed by timings of surgery and surgical techniques. In spite of all these constrains, PSIO appliances have evolved from simple strapping to aligner technology. The advent and usage of digital technology have been greatly influenced in the field of PSIO.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

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  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]

  [Table 1], [Table 2], [Table 3], [Table 4]


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