Modified indigenous nasal elevator for cleft lip and palate patient: A novel clinical innovation

Abstract

Pre-nasoalveolar molding (PNAM) was developed to reduce the severity of the initial cleft alveolar and nasal deformity. The nasoalveolar moulding appliance (NAM) consists of an intraoral moulding plate with nasal stents to mould the alveolar ridge and nasal cartilage concurrently. Use of the NAM technique also reduces surgical columella reconstruction and the resultant scar tissue in bilateral cleft lip and palate. The nasoalveolar moulding technique has been shown to significantly improve the surgical outcome of the primary repair in cleft lip and palate patients compared to other techniques of presurgical orthopaedics. But the adaptability of nasal stent with support from NAM plate is cumbersome for many cleft patients due to its bulkiness, interfere with feeding and difficult for parents to manage at home. The Modified Indigenous Nasal Elevator (MINE) is a novel innovation for nasal correction for cleft lip and palate patients. This innovative design, non-invasive, precision, fewer visits, cost effective and adaptability make it a valuable tool to help surgeons to achieve optimal correction in lip repair surgeries in cleft lip & palate patients. MINE's innovative design allows for customization based on the patient's specific nasal anatomy. This adaptable feature ensures optimal fit and function for each patient, maximizing the surgical outcomes.

Introduction

Infants born with cleft lip and palate can have their alveolus, lip, and nose presurgically molded using a novel procedure pre-nasoalveolar molding (PNAM) that lessens the severity of the original nasal and cleft alveolar deformity described by Grayson et al.¹ in 1999. Matsuo conducted the first studies on the molding of nasal cartilage in newborns, utilizing silicone tubes to construct the nostril.² To simultaneously mold the alveolar ridge and nasal cartilage, the nasoalveolar molding appliance (NAM) comprises of an intraoral molding plate with nasal stents. Use of the NAM technique also reduces surgical columella reconstruction and the resultant scar tissue in bilateral cleft lip and palate. However, many cleft patients find the nasal stent's adaptability with support from the NAM plate to be burdensome because of its bulkiness, which can interfere with feeding and make it challenging for parents to handle at home.³ This case report highlights the Modified Indigenous Nasal Elevator (MINE), which is a novel innovation for nasal correction for cleft lip and palate patients. Its innovative design, non-invasive, precision, fewer visits, cost effective and adaptability make it a valuable tool to help surgeons to achieve optimal correction in lip repair surgeries in cleft lip and palate patients.

Case report

A two-day old infant baby boy had unilateral cleft lip and palate of the left side making breathing and breastfeeding difficult as described by parents. No familial history and parental history were given by parents for cleft lip and palate. Also, there was no history of prenatal diagnosis of the cleft area. Extra orally patient had cleft over upper lip of approximately 14 mm gap which is extending up to base of left columellar sulcus along with depressed nasal dome of left side (Fig. 1A and B). Columella was also found to be deviated towards the unaffected right side. Because of the gap present in cleft region patient was not able to maintain lip seal while sucking and had difficulty in feeding as well as breathing. Intraorally cleft is complete and extending to involve alveolus, soft and hard palate however uvula is unaffected. There is oroantral communication present between nasal and oral cavity. Hence the diagnosis was summarised as unilateral combined palatal cleft type ‘b’ involving lip, alveolus, soft and hard palate on left side as per Pruzansky classification.⁴

Fig. 1.

Pretreatment photograph and cast showing intersegmental cleft area.

Treatment plan and treatment procedure

Comprehensive treatment plan formulated in different phases are as follows: - (a) Phase I – Pre surgical Nasoalveolar molding (b) Phase II –Lip closure (to be done at the age of 3months (c) Phase III –Palate closure (to be done at the age of 15–18 months). A heavy-bodied impression material was used to take the initial impression following the American Cleft Palate Association classification (ACPA) guidelines and construct the plate.⁵ Parents were instructed to keep the plate in full time, and to take it out for cleaning as needed, at least once a day. The appliance was secured extra orally to the cheeks, bilaterally by surgical tapes, which have an orthodontic elastic band at one end. After reduction of occult area less than 5 mm, nasal molding is facilitated by fabrication of modified indigenous nasal elevator to bring nasal dome to intended position before commencement of lip repair (Fig. 2B). The unique design of appliance also makes it easy to add and remove tissue conditioning material to alter the height and width of alar dome area in cleft side depending on which side the molding is needed i.e. if there is a depression in the area of the lateral dome of the cleft or the vertical height in the lowered nose segment is increased in the cleft segment. When lifting the nose in cleft segment, an optimum force of 15–20 g is sufficient to raise the area of the alar dome in cleft side to the desired shape. As the alveolar segments were in alignment and gap reduces to 2.5 mm patient was subjected to lip repair by modified Millard Tennison flap surgery and primary rhinoplasty was carried out to facilitate the restoration of normal nasal dome shape simultaneously. Post-operative extraoral set of photographs following surgery and 4 week following surgery reveals improvement in contour of nose, lip esthetics and function (Fig. 2A, B & C). As treatment protocol, we have kept the MINE appliance after surgical intervention for six months, so that obtained shape of corrected nasal area in cleft area can be maintained with minimum relapse. Patient/ guardian consent was obtained for inclusion in the study.

Fig. 2.

A. Presurgical photograph after nasoalveolar molding B. Patients with modified indigenous nasal elevator C. Photograph showing Millard Tennison lip repair method.

Photographic analysis and cast at various stages reveal an improvement in the vertical level of nasal alae. Discrepancy in the vertical level of both sides of alae, which was 5 mm differential reduced to 3 mm prior to surgery, reduced by 2.5 mm after surgery as revealed in 3D scan of maxillary cast. Nasal tip deviation from the midsagittal reference plane reduced from 4 to 1 mm prior to surgery and became nil after surgery (Fig. 3A, B & C). Measurements of these records were done 3 times during the first 4 months of treatment, which revealed a gradual cleft reduction amounting to 14 mm in the alveolus and 2.5 mm in the palatal segments with restoration of symmetrical alar dome base (Fig. 4) (Table 1).

Fig. 3.

(A-D)- Sequential photographs cast showing overall reduction in cleft defect.

Fig. 4.

Modified indigenous nasal elevator with traction element for restoration of alar base dome area.

Table 1.

Photographic analysis in different time interval.

	Case
	Phase 1	Phase 2	Phase 3
Alar height
Right	5 mm	3 mm	2.5 mm
Left	5 mm	3 mm	2.5 mm
Deviation of nasal tip fromfacial midline	4 mm	1 mm	0 mm
Intersegmental cleftdistance	14 mm	2.5 mm	0 mm

Phase 1 = Pretreatment, Phase 2 = Presurgical, Phase 3 = Post treatment.

Discussion

Current advancements in the treatment of cleft lip and palate (CLP) have focused on preoperative orthopaedic treatment to improve surgical outcomes. The use of nasal stenting, presurgical orthopaedics, and PNAM has all attempted to improve facial symmetry before surgery.^6,7 The goal of PNAM is to align the alveolar cleft segments and to correct deformed nasal cartilage and soft-tissue asymmetry. The traditional NAM technique, as pioneered by Grayson et al,¹ has shown promise in achieving these goals. However, its bulkiness, interference with feeding, and the associated challenges for parents and caregivers can be significant barriers to its widespread adoption. Dynacleft/CAD NAM devices are also available for the correction of nasoalveolar defect in cleft patients. But major drawbacks are cost, alteration of plate not possible for reshaping alar dome area and require multiple set of elevators especially in Dynacleft. MINE's innovative design allows for customisation based on the patient's specific nasal anatomy. This adaptable feature ensures optimal fit and function for each patient, maximising the surgical outcomes. It's simple and inexpensive design leads to precise and controlled elevation of the nasal cartilages, accurate and symmetrical correction of the nasal deformity, enhanced grip and manoeuvrability, minimal risk of tissue damage, enhanced nasal airway function, enhanced patient acceptance compared to other contemporary options. The case report presented highlights the potential of MINE to prepare the presurgical phase, making subsequent surgical interventions more straightforward and potentially more successful.

Conclusion

Presurgical molding with MINE is a practical and helpful approach to help cleft lip and palate patients rectify their birth deformities of the cleft nasal cavity, facilitate surgery, and achieve favourable surgical outcomes. The (MINE) presents promising results for nasal corrective procedures performed on patients with cleft lip and palate. Orthodontist may find it to be an invaluable tool because to its inventive design, accuracy, and versatility. To determine the MINE's long-term effectiveness in cleft lip and palate procedures, more research with bigger patient groups and longer follow-up times is necessary.

Disclosure of competing interest

The authors have none to declare.