Early presurgical nasoalveolar molding for bilateral cleft lip and palate: a case report

Abstract

Background

Bilateral cleft lip and palate is a severe orofacial anomaly associated with wide alveolar defects and complex nasal deformities. Surgical repair of such a defect is challenging and increases the risk of compromised esthetic and functional outcomes. Early presurgical nasoalveolar molding (PNAM) is a non-surgical orthopedic technique used to reduce cleft severity and improve nasal form prior to surgical repair. This case demonstrates the tangible clinical benefits of early intervention in optimizing surgical conditions and outcomes in a complex bilateral cleft presentation.

Case presentation

A 20-day-old Indian male infant with complete bilateral cleft lip and palate underwent PNAM therapy using a custom intraoral molding plate with a nasal stent and lip taping. Therapy was continued for 4 months, resulting in a reduction in alveolar cleft width from 11 to 5 mm and improvement in nasal morphology. Primary bilateral cheiloplasty was performed at 5 months of age, followed by palatoplasty at 11 months. Postoperative healing was satisfactory, with improved feeding and age-appropriate speech development.

Conclusions

Early PNAM therapy in infants with BCLP substantially reduces alveolar defect size, improves nasal morphology, and facilitates optimal outcomes, supporting its role as an important adjunct in comprehensive cleft management.

Background

Cleft lip and palate are common congenital anomalies worldwide, with a notably high incidence in Asian countries. In India, it affects 1 in 1000 live births, resulting in 27,000–33,000 cases every year from approximately 24.5 million births, or about 3 babies born every hour [1].

This congenital anomaly results from the failure of fusion of various facial processes during the fourth week of embryogenesis. The failure of the frontonasal and maxillary processes to fuse leads to a cleft lip, while the failure of the maxillary process palatal shelves to fuse results in a cleft palate [2]. The typical presentation of bilateral cleft lip and palate includes a protrusive and mobile premaxilla, collapsed lateral maxillary segments, and a severely shortened, bifid columella with splayed alar cartilages [2, 3]. Bilateral cleft lip and palate represent a severe form of orofacial cleft that poses significant challenges in terms of esthetics and function, as it is mostly associated with wider cleft defects and severe nasal deformities, such as absent columella and flattened alae. Early management facilitates feeding, improves esthetics, and prepares the alveolar and nasal structures for primary surgical closure. This makes PNAM therapy more critical in BCLP cases.

Presurgical nasoalveolar molding (PNAM) was introduced by Grayson et al. in 1999 as a presurgical orthopedic technique to improve nasal symmetry and reduce the width of the alveolar defect [4]. This technique utilizes the plasticity of neonatal cartilage and bone by applying gentle, controlled forces via an intraoral plate with a nasal stent. PNAM aims to reduce the width of the alveolar cleft, elongate the columella, and mold the nasal alar cartilages into a more anatomic position before the first surgery [5]. This report details the application and outcomes of PNAM therapy in a neonate with complete BCLP, followed by staged surgical repair, highlighting the clinical protocol, challenges, and the achieved outcome.

Case presentation

A 20-day-old Indian male infant was referred to the Department of Orthodontics. The chief complaints reported by the parents were a bilateral cleft lip and palate and nasal regurgitation during feeding. The patient was born at full term, via normal vaginal delivery to nonconsanguineous parents with no significant family history. No other associated congenital anomalies were seen.

Extraoral examination revealed a bilateral cleft lip extending to the base of the nose with a measured defect of 12 mm at the vermilion border. The nasal morphology showed a severely shortened columella, depressed nasal tip, and splayed, flattened alar cartilages bilaterally (Fig. 1A–C). The intraoral examination confirmed a complete cleft palate of width 11 mm (Fig. 1D).

Fig. 1.

Pre-treatment extraoral and intraoral views showing bilateral cleft lip and palate with nasal deformity. (A) Frontal view showing complete bilateral cleft lip; (B) Lateral profi le view showing nasal deformity; (C) Basal viewshowing shortened columella and flattened alar cartilages; (D) Intraoral view showing complete bilateral cleft palate

Treatment protocol

A comprehensive treatment plan was formulated based on the clinical findings, with the objectives of reducing the interalveolar defect size, correcting depressed alar cartilage, achieving bilateral nasal symmetry, lip repair, and, finally, palate repair. The treatment approach consisted of PNAM followed by primary cheiloplasty and subsequent primary palatoplasty.

Presurgical intervention

An impression was taken using heavy-body silicone to fabricate a custom acrylic plate with a nasal stent (Fig. 2A). The treatment was initiated with lip taping, which involves applying surgical tape bilaterally across the cleft segments.

Fig. 2.

Fabrication and delivery of PNAM appliance with nasal stent. (A) Primary impression of the maxillary arch; (B) Master cast obtained from the impression; (C) Fabricated PNAM appliance; (D) Intraoral delivery of the PNAM appliance with retention tapes

The nasal stent was fabricated from 0.032-inch stainless steel wire, embedded in a plate, and adjusted to support the alar cartilage and the left columella (Fig. 2D). In the second visit, the plate was delivered (Fig. 4) and retained using surgical tapes extended from the cheeks. Parents were instructed on the daily insertion, removal, cleaning, and taping procedure. The appliance was selectively trimmed weekly to remove acrylic from the cleft area to allow medial approximation of the cleft segments along with upward and forward bending of the nasal stent. PNAM therapy was continued for 4 months. At the end of the 4-month period, the defect size reduced to 5 mm, with improved nasal form and columellar length (Fig. 3D).

Fig. 4.

Postoperative photographs following primary bilateral cheiloplasty. (A) Frontal view after lip repair; (B) Basal view showing nasal form after cheiloplasty; (C) Right lateral profi le view; (D) Left lateral profi le view

Fig. 3.

Reduction in alveolar cleft width during PNAM therapy. (A) Frontal extraoral view after PNAM therapy; (B) Lateral profi le view demonstrating improvement in nasal projection; (C) Basal view showing improved columellar length and nasal symmetry; (D) Intraoral view showing reduction in alveolar cleft width

Surgical phase

Upon completion of PNAM therapy, the patient was 5 months. The patient underwent primary bilateral cheiloplasty using Millard’s technique, achieving satisfactory esthetic outcomes. Primary palate repair was performed at 11 months of age. The two-flap palatoplasty technique was employed to achieve closure of the hard and soft palate (Fig. 4).

Outcomes and result

The PNAM therapy resulted in reduction in defect size from 11 to 5 mm. Clinical progression was documented with serial extraoral and intraoral photographs demonstrating significant clinical improvement in the alveolar defect, elongated columella, and nasal tip projection (Fig. 5).

Fig. 5.

Progressive reduction in alveolar cleft width during PNAM therapy. (A) Pretreatment maxillary cast showing wide alveolar cleft; (B) Post-PNAM maxillary cast demonstrating reduction in alveolar cleft width

The postoperative photographs following lip repair (Fig. 4) and palate repair (Fig. 6) showed a well-repaired lip with satisfactory Cupid’s bow and philteral columns and a closed palate.

Fig. 6.

Outcome after palatoplasty showing improved nasal and alveolar morphology. (A) Frontal view after palatoplasty; (B) Lateral profi le view; (C) Basal view showing improved nasal morphology; (D) Intraoral view demonstrating complete palatal closure

Primary palatoplasty achieved complete closure of the palatal cleft with adequate velopharyngeal competence. Post-surgical follow-up at regular intervals showed satisfactory healing with no complications. The patient demonstrates age-appropriate feeding and speech development. The parents expressed high satisfaction with the esthetic and treatment process. The chronological sequence of presurgical and surgical interventions for this patient is summarized in Table 1, outlining the complete treatment timeline from the initiation of PNAM therapy to postoperative follow-up.

Table 1.

Clinical timeline of treatment

Age	Intervention
20 days	Initiation of PNAM therapy
1–4 months	Weekly PNAM adjustments
4 months	Completion of PNAM (defect reduced to 5 mm)
5 months	Primary bilateral cheiloplasty
11 months	Primary palatoplasty
Follow-up	Satisfactory healing and development

Conclusions and discussion

The management of BCLP requires a multidisciplinary approach. The primary challenge in BCLP is protruding premaxilla and lip closure, without reducing the defect size, which could lead to excessive tension; thus, PNAM plays a pivotal role in such cases [6]. The conventional approach for BCLP management, that is, primary lip repair surgery without presurgical management, often results in suboptimal outcomes requiring multiple revision surgeries [7]. The decision to manage this patient with PNAM was made.

The present case PNAM was initiated at 20 days of age, which is an optimal time for the maximum cartilage plasticity [8] Lip taping was performed prior to PNAM therapy, because it served multiple purposes, including initiating early approximation of the lip segment, reducing overall treatment time, allowing assessment of the family’s compliance, and conditioning the tissue for subsequent appliance therapy [9, 10].

The reduction of the defect from 11 to 5 mm in this case is consistent with outcomes reported in the literature. Studies have shown a 50–70% reduction in defect size, facilitating tension-free primary lip repair [11].

One of the most significant advantages of PNAM, along with a nasal stent, is improvement in nasal morphology, particularly in bilateral clefts, where the columella was severely deficient [4] Traditional BCLP repair often requires secondary columellar lengthening procedures; however, with adequate PNAM therapy, columellar elongation can be achieved nonsurgically through progressive adjustment of the nasal stent [12].

The timing of surgical intervention following PNAM is based on several factors, including the degree of alveolar defect, patient age, weight, and the surgical team’s assessment. Most studies suggest primary lip surgery after reduction of defect width to 3–5 mm, which is usually achieved in 3–4 months [13] In this case, surgery was performed at 5 months of age, which aligns with contemporary recommendations for early cleft repair.

Primary palatoplasty was performed at 12 months of age. Early palatal repair is important for speech development as closure before 12–18 months optimizes the potential for normal speech development [12]. However, the overall health of a child must also be considered, and treatment time should also be balanced.

Long-term studies have demonstrated that PNAM therapy results in sustainable improvement and reduced need for secondary nasal surgery. A randomized controlled trial by Shetty et al. assessing the long-term effects of PNAM concluded that PNAM significantly improves esthetic outcomes compared with surgery alone, with benefits persisting into adolescence [14].

Conclusion

PNAM represents a valuable non-surgical intervention in the comprehensive management of bilateral cleft lip and palate. This case demonstrates that the PNAM, when initiated early and executed systematically, can significantly reduce alveolar defect size, improve nasal morphology, and facilitate optimal surgical outcomes. The favorable outcomes achieved in this case support the continued use of PNAM as an integral component of bilateral cleft lip and palate management.

Patient perspective

The patient’s parents reported significant improvement in feeding ability and ease of care following presurgical nasoalveolar molding. They expressed high satisfaction with the nasal appearance after lip repair and were reassured by the staged treatment approach.

Abbreviations

BCLP

Bilateral cleft lip and palate

PNAM

Presurgical nasoalveolar molding

mm

Millimeter

Author contributions

ST managed the case and contributed to manuscript drafting. All authors read and approved the final manuscript.

Funding

Open access funding provided by Datta Meghe Institute of Higher Education and Research. The authors received no specific funding for this work.

Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Declarations

Ethics approval and consent to participate

Ethical approval was not required for this single case report, in accordance with the Institutional policy.

Consent for publication

Written informed consent was obtained from the patient’s legal guardian for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.

Competing interest

The authors declare that they have no competing interest.