**Abstract**

Presurgical infant orthopaedic (PSIO) protocol is applied prior to cleft Lip and/cleft palate surgical intervention to facilitate the repair by restoring the alar base and maintaining the skeletal, soft tissue harmony. The objective of this review is to assess the literature on the presurgical infant orthopaedic protocol most widely used and accepted. Searches were made in PubMed, Cochrane and Google Scholar on cleft lip and/palate. A large number of articles documented approaching PSIO for cleft treatment with the intent to provide a satisfactory treatment for cleft patients, requiring far more than just correctional surgery and its ability to do so is unique. Craniofacial Orthodontists can choose from a wide array of treatment options for their patients and can learn from the outcomes attained by applying a combination of outcomes at various other centers.

**Keywords:** Systematic review, cleft lip, cleft palate, presurgical, infant orthopaedics, PSIO

### **1. Introduction**

Pre-Surgical Infant Orthopaedic (PSIO) protocol indisputably has a valuable impact in the management of cleft lip and palate infants, showing approximation and alignment of alveolar segments and narrowing the gap between lip components, with the intent of separating oral cavity from nasal and maintaining the tongue position. However, nasal cartilage symmetry and increase in the columella length results remain distinctive [1], with long term benefits still under speculations. Although the popularity of NAM has grown by leaps and bounds in the last one decade, it has become essential to annotate the outcome of both NAM and other PSIO protocols. Studies regarding NAM have been either case studies or single center retrospective comparisons of before-and-after clinical features on small samples with no control non-NAM cases.

### **2. Discussion**

An evidence-based approach to cleft lip and palate management in the last two decades has led many craniofacial orthodontists to show great enthusiasm for presurgical infant orthopaedics (PSIO). Patients with unilateral and bilateral complete cleft lip and/palate demand far more than just correctional surgeries. Any manipulations of the infant's orofacial complex prior to nasal and lip surgical repair is conducted under the aegis of term presurgical infant orthopaedics (PSIO).

An inevitable manifestation of cleft lip and palate remains to be primary nasal deformity, presenting a significant surgical challenge requiring patients to undergo multiple surgical procedures.

Advocates of PSIO have stated, besides improving arch form and facilitating arch closure, its main objective is improving nasal symmetry and lip aesthetics. In order to make cleft lip and/or palate care cardinal for these patients, it's essential to understand these protocols and develop a more centralised approach. The aim of the present review is to provide scientific literature on most current PSIO appliances in patients with CLP and to analyse the current state of PSIO (**Table 1**).

This evidence based review registered at the international prospective register of systematic reviews, PROSPERO, with the following registration number CRD42021280979. The report followed the preferred Reporting items for Evidence based reviews and Meta-Analyses (PRISMA) 2020 edition. Three electronic Databases namely PubMed, Cochrane & Google Scholar Library on Cleft-Lip and/Palate were searched and used in the current study. Studies that were conducted between the years 2011 and 2021 with the primary keywords were searched. We used search strategies involving the MeSH descriptors and 61 studies met the inclusion criteria.

The main descriptors used were as follows:



#### **Table 1.**

*Treatment modalities in the management of unilateral cleft lip and palate which are often based on chronological age.*

*Protocols in Presurgical Infant Orthopaedic Treatment—An Evidence Based Review DOI: http://dx.doi.org/10.5772/intechopen.106670*

#### **Figure 1.**

*The flow chart above outlines the selection process of articles.*

All abstracts provided by the databases in the searches were collected resulting in a total of 136 articles. From these abstracts, studies that clearly did not include presurgical infant orthopaedics were excluded. After meticulous reading of the full text articles, 21 articles were included for the analysis of the obtained conclusion (**Figure 1**). Further assessment of the literature for inclusion in this review was performed by evaluating the full text based on the selection criteria. Literatures that were not in line with the selection criteria were then excluded from the study. Quality assessment and data synthesis were completed independently by two investigators (NK and AF) and any discrepancies were resolved by consultation with the third author (MZ).

The following inclusion criteria were used for the evidence based review:


The protocols enlisted in the 21 articles are as follows:


In order to conduct a successful clinical practice with PSIO protocols, the systematic reviews and RCTs are considered the most appropriate evidence. The main search engine proposed by World Health Organisation i.e. PubMed and Cochrane Library, along with google scholar were used to find the RCTs to formulate a study for evidence based medicine. A total of 136 articles were found, and we reached 21 articles that proposed PSIO protocols on cleft patients.

PSIO came into existence with McNiel in 1950 using buccal plates to manipulate the alveolar segments. Beginning with Grayson and Colleagues [2] in 1993, has inspired many orthodontists over the last few decades to develop a protocol that not only shapes the nasal cartilage, but also mould's the alveolar process. Two of the most favoured PSIO protocols employed are Nasoalveolar moulding and Latham-Millard technique [3] with the later potentiating a successful GPP and obligating nasolabial fistula prior to secondary bone graft [4], while the former aims at reducing the severity of cleft defect in both UCLP and BCLP infants [2]. In UCLP infants the cleft defect between the alveolar segments is approximated, the lip elements are brought close together and the deviated columella is repositioned. For BCLP infants, the Grayson NAM technique successfully retracts the Premaxilla and the alveolar segments are widened for alignment. The columella is elongated non-surgically [2]. The direct benefit of using the Latham device as part of pre-surgical infant dentofacial orthopaedic is ease of gingivoperiosteoplasty. Millards, an acclaimed plastic surgeon, modified the Latham's fixed appliance such that it amalgamated with his surgical protocol reporting a significantly reduced number of fistulas post-operative [5]. However, the Latham dento-maxillary orthopaedic appliance used screws to approximate the alveolar segments in unilateral complete cleft patients. A "Modified Latham "appliance designed by Stephen Ruso and Ernest Ruas at John Hopkins Hospital, Florida claims that the use of elastic power chain instead of screws to approximate the alveolar segments reduces the treatment time to 2 weeks [6].

Lip tapping alone has been labelled as a tyrannised PSIO protocol in spite of it being a simple and inexpensive procedure, which is even more pressing when dealing with a lifelong condition such as cleft lip and palate. The dearth of impression making


*Protocols in Presurgical Infant Orthopaedic Treatment—An Evidence Based Review DOI: http://dx.doi.org/10.5772/intechopen.106670*

**Table 2.**

*Conclusion of articles that used various presurgical infant orthopaedic (PSIO) techniques.*

and appliance fabrication permits the early start of treatment exhibiting good maxillary arch dimensions and lip approximation [7].

Inspired by the technique employed by Berggren and Berggren et al., in 2002 a simple nasal elevator composed of plastic, with an elastic band pasted on the forehead was used to approximate the cleft edges [8]. A new and simpler way of providing PSIO gave rise to Dynacleft, where the maxillary segments are approximated indirectly aided by force factors coming from lip muscle traction [9]. Due to the dentoalveolar growth and simultaneous cleft reduction, the need for fabricating new plates demands the nasal stents to be re-mounted, adding to the visiting appointments. This leads to a quick-lock system for nasal stent transfer, minimising the wire adaptations. The addition of CAD/CAM technology has not only saved the chair side time, but significantly increased the cleft side nasal height and improved the nasal symmetry [10]. It's use is on ever increasing rise for recording details in cleft-Lip and Palate patients and is relatively less risk averse and more precise when compared to the primitive impression making procedure [11]. A series of case results documenting PSIO cases treated with CAT has opened a window to a new and exciting future [12].

A modified, yet simpler and cheaper technique called "The SAC-PP-MR "technique recently came into existence with the intent to target all, to not only facilitate cheiloplasty and ensure positive aesthetic outcome. It successfully documented reducing the cleft size to zero [12].

Presurgical Infant Orthopaedic Treatment (PSIO) has been accepted and acknowledged into practice by the majority of multidisciplinary cleft teams around the world attributing the cleft defect repair and primary nose surgery [13–15]. An inter center comparison study using Asher-McDade scale demonstrated a significantly favourable outcome in nasolabial appearance scores Vs outcomes resulting from primary surgical repair only [16]. Craniofacial Orthodontists can choose from a wide array of treatment options for their patients and can learn from the outcomes attained by applying a combination of outcomes at various other centers. However, attempts have been made by craniofacial orthodontists to modify PNAM device with the intent to simplify the fabrication and reduce the frequency of recall visits [17]. Distance as a factor has been obsolete from many discussions advocating the use of PSIO or eliciting the need for newer PSIO techniques [18], however it has been revealed to cause a significant difference in the delivery of cleft care (**Table 2**).
