|Year : 2021 | Volume
| Issue : 2 | Page : 103-108
Role of presurgical nasoalveolar molding in the repair of unilateral cleft lip
Subhrangshu Dutta1, Kartik Chandra Mandal2, Saheli Majumder3, Sourav Roy4, L Neilasano5, Pankaj Kumar Halder4
1 Department of Pediatric Orthodontic Surgery, Dr. B.C. Roy Post Graduate Institute of Pediatric Sciences, Kolkata, West Bengal, India
2 Department of Pediatric Surgery, Dr. B.C. Roy Post Graduate Institute of Pediatric Sciences, Kolkata, West Bengal, India
3 Department of Orthodontia, Mayapur Community Hospital, Mayapur, West Bengal, India
4 Department of Pediatric Surgery, R. G. Kar Medical College, Kolkata, West Bengal, India
5 Department of General Surgery, R. G. Kar Medical College, Kolkata, West Bengal, India
|Date of Submission||12-Aug-2021|
|Date of Acceptance||28-Sep-2021|
|Date of Web Publication||11-Feb-2022|
Dr. Pankaj Kumar Halder
Saroda Pally, Baruipur, Kolkata - 700 144, West Bengal
Source of Support: None, Conflict of Interest: None
Aim: A study aims to reappraise the merits of nasoalveolar molding before the repair of unilateral cleft lip.
Materials and Methods: A prospective study was conducted with 20 cases of the unilateral complete cleft lip for 3 years. We counseled the parents, offered them to choose the surgical procedure with/without preoperative nasoalveolar molding (NAM), and obtained consent from them. The nasolabial closure was done either after aligning the cleft segments with NAM or without preoperative NAM. The patients were followed up for 1 year and assessed. Both groups are then compared with normal healthy individuals of the same age group.
Results: Depending on preoperative NAM, the patients were divided into Groups A (without NAM) and B (with NAM). All the facial proportions and angles (except oral commissural width: facial width and nasal tip angle) of Group B are much closer to the values of normal age-controlled individuals. However, a significant difference existed between the Group A values and normal individuals. Group B showed better nasal symmetry and restoration of normal proportions. The quality of scar produced was significantly superior in Group B when compared to Group A. Body weight change was also significantly different in the two groups. Group B seemed to catch the 15th percentile while Group A stayed at the 3rd percentile in the postoperative period.
Conclusion: Presurgical NAM helps to restore the normal facial proportions and produces a healthier scar. Furthermore, the bodyweight of patients seems to improve as the NAM plate acts as a feeding plate.
Keywords: Cleft lip, facial proportion, nasoalveolar molding plate, nasoalveolar molding, presurgical, scar
|How to cite this article:|
Dutta S, Mandal KC, Majumder S, Roy S, Neilasano L, Halder PK. Role of presurgical nasoalveolar molding in the repair of unilateral cleft lip. Int J Oral Health Sci 2021;11:103-8
|How to cite this URL:|
Dutta S, Mandal KC, Majumder S, Roy S, Neilasano L, Halder PK. Role of presurgical nasoalveolar molding in the repair of unilateral cleft lip. Int J Oral Health Sci [serial online] 2021 [cited 2022 May 24];11:103-8. Available from: https://www.ijohsjournal.org/text.asp?2021/11/2/103/337496
| Introduction|| |
Cleft lip and palate have a great negative social impact on the patient and family members. Various surgical methods for the treatment of cleft lip have developed over the years. The presurgical reduction in osseous and soft tissue cleft deformity considerably reduces the magnitude of the surgical challenge, resulting in improved surgical outcomes. The NAM, introduced by Grayson in 1993, is such a presurgical modality. The principal objective of presurgical NAM is to reduce the severity of the initial cleft and nasal deformity and facilitate surgical soft tissue repair in optimal conditions under minimum tension. It allows nasal molding and lengthening of the columella during the presurgical period. The ideal time to initiate NAM is preferably within the 1st and 2nd weeks of birth as the nasal cartilage is still developing due to raised level of hyaluronic acid and maternal circulating estrogen which make a much easier molding of the tissue during the first 6 months of the life. In the present study, an attempt was made to evaluate the merits of presurgical NAM in the unilateral complete cleft lip by comparing with similar cleft patients operated without presurgical NAM.
| Materials and Methods|| |
From January 2010 to July 2011, 20 patients with unilateral cleft lip were selected for this study. Primary cases and otherwise normal healthy within 1 year of age in whom long periodic check-up and follow-up were possible were included. Syndromic patients compromised by other systemic diseases were excluded from this study. The patients were randomly included in one of the following two groups. The parents were offered two different treatment protocols. Informed consent has been explained and signed by the guardians of the patients. The first group (Group A) where nasolabial closure was done without doing a presurgical NAM. The second group (Group B) where NAM was done before the nasolabial closure [Figure 1].
|Figure 1: (a) The nasoalveolar molding plate. (b) The nasoalveolar molding plate in place|
Click here to view
Postoperative (PO) care was focused on feeding and wound care. Feeding was typically performed using a syringe with a soft catheter attached to deliver the formula to the oropharynx. Routine feeding was resumed within 3 weeks of surgery. The wound was cleaned several times daily with normal saline and topical antibiotic ointment was applied. Skin sutures were removed on or around the 5th PO day and assessment of any complications was checked [Figure 2]. Subsequent follow-up was done at 1-month, 3-month, 6-month, and 12-month intervals. The nasal floor was checked endoscopically for dehiscence and the oronasal fistula after 6 months. The scar was scored using a quantitative scale for clinical scar assessment. Facial proportions, angles, and body weights recorded at different time points were compared between Groups A and Group B and with data recorded from normal individuals of the same age-controlled groups. All measurements were compared using unpaired t-tests. Statistical significance was determined at P < 0.01. Data were analyzed using IBM SPSS statistics 18.104.22.1687 (IBM, Armonk, New York, USA).
|Figure 2: Clinical picture showing a reduction of alveolar cleft after 3 months|
Click here to view
| Results|| |
The male–female ratio and age distribution in both Group A and Group B are given in [Chart 1]. The mean age of patients was 1.4 months in Group A and 1.5 months in Group B. Thirteen (65%) patients had cleft lip+-palate on the left side and seven (35%) had cleft lip+-palate on the right side. Gingivoperiosteoplasty could be done in four out of ten patients in Group A, whereas it was done in all patients of Group B. However, none of the patients had oronasal fistulas.
The mean of preoperative and PO values of each facial proportion was studied separately and compared between the groups and normal individuals [Table 1]. Bodyweight measurements at 2-month preoperative and 8-month PO were calculated and analyzed (unpaired t-test). Preoperative body weights of the two groups showed a nonsignificant P = 0.9096, while the PO body weights of the two groups showed an extremely significant P value (0.0003) [Table 2]. Postoperatively, Group A male patients were seen to be below the 3rd percentile, and female patients were seen to be above the 3rd percentile. Group B patients were seen to be above the 15th percentile of body weights.
|Table 1: Comparison table of facial proportions of the control, Group A (preoperative and postoperative) and Group B (preoperative and postoperative)|
Click here to view
|Table 2: Comparison of postoperative body weight (at 2 months, 8 months) in nonnasoalveolar molding, nasoalveolar molding group|
Click here to view
PO nasal endoscopy showed none of the cases had dehiscence or oronasal fistula or obstruction of the repaired nose. Regarding the PO scar assessment, Group A showed a higher score with a mean score of 8.9 compared to Group B with a mean score of 7.7. The two-tailed P value between the two Groups A and B is 0.0054, considered very significant [Table 3].
|Table 3: Comparison of the scar (scored using a quantitative scale for clinical scar assessment in nonnasoalveolar molding, nasoalveolar molding group)|
Click here to view
This study revealed no difference between the means of preoperative values of facial proportion between the two Groups A and B. Quite expectedly, there was an extremely significant difference between the means of preoperative and PO values of facial proportion in Group A, Group B as well as with normal individuals. Comparison between the means of Group A, PO values of this proportion, and normal individuals showed significant difference. However, a comparison between the means of Group B, PO values of this proportion, and normal individuals showed no significant difference. Finally, a comparison between the means of PO values of this proportion between the two Groups A and B revealed an extremely significant difference.
| Discussion|| |
A cleft lip is a congenital anomaly produced by embryological defects during the formation of the face. The worldwide prevalence of cleft lip and palate is 1:600 and it is about 27,000 and 33,000 clefts per year, respectively, in India., Unilateral clefts have been found to be nine times as common as bilateral clefts and it occurs twice as frequently on the left side than on the right. The cleft lip and palate population comprises more males than females, whereas isolated cleft palate occurs more commonly in females, consistent with the results in our study.
Repair of cleft lip dates to prehistoric times, as early as 390 BC in China. Naturally, numerous repair methods have been employed for these deformities. Management ranged from resection of the premaxilla to its active repositioning by removable or fixed orthopedic appliance. Despite the use of these advanced techniques and modalities and overall change in treatment philosophies, some of the patients suffer from residual lip and nasal deformities urging additional care for definitive correction. The severity of the residual deformities depends primarily on the initial cleft. Wide alar base, deficient or absent columella, deviation of the nasal tip or any other gross asymmetries poise problems that need to be addressed seriously. If the defect and the deficiency are more, extensive dissection and manipulation of the nasal structures are warranted by principle.
In 1950, McNeil described the first intraoral presurgical orthopedic appliance to stimulate tissue growth and reduce the width of the alveolar and palatal cleft. Initially, a passive appliance, Hotz plate, was used to create alveolar alignment by spontaneous development of the bilateral segments. Active appliances such as Latham appliance that is retained by surgically installed pins and delivers controlled forces have been developed in the 1980s. Finally, in 1990, Grayson introduced a third category of presurgical infant appliances, semiactive, called the NAM appliance [Figure 1].
Numerous benefits of the NAM technique have been described, as it helps to narrow the cleft width and improves the position of the cleft fragments, leading to effortless primary repair of lip alveolus and nose, attaining superior surgical outcome with less scar formation, decreased alar curvature and increased length of the columella., Deng et al. reported alveolar cleft narrowing by 0.5 mm after 1 month's treatment, Singh et al. arrived at 2.2 mm lifting after 3.5 months, and Pai et al. observed a reduction of the alveolar cleft by 5.8 mm after 3–4 months of treatment. In the present study, it is seen that a reduction of the alveolar cleft up to 5 mm was achieved within a period of 3–4 months. The results are consistent with similarly treated cases described in the literature. The average age of reporting of the patients was 43.5 days, and the average age at which NAM was initiated was 48.5 days. This is near the end of the ideal cartilage-molding period, which is to be within the first 6–8 weeks of life. Liou et al. achieved an average 2.7-mm alar elevation within 1–3 months, but the reduction of cleft-sided alar height did not proceed any further after 1 year of PO period.
Employing the NAM, the position of the premaxilla improved in harmony with the alveolar segments. Laxation of the alar cartilages was achieved leading to easy elevation and suturing. Conversely, improvement of the alar cartilage stimulated the growth of the nasal mucosal lining. Thus, the affected nostril could be reconstructed of adequate shape and fullness. Long-term therapy with NAM decreases the requirement of surgical revisions for oronasal fistula, excessive scar tissue, and lip and nose deformities. However, none of the patients from either of the groups in our study population had oronasal fistulas.
Presurgical NAM has a direct impact on the PO scar, body weight, and acceptability. For analysis of the scar, a New Quantitative Scale for Clinical Scar Assessment by Beausang, Floyd, Ferguson, and Orton was used in this study. The quality of scar produced was significantly superior in Group B when compared to Group A. The Group A patients showed a higher score on the clinical assessment scale. The scars obtained in Group B patients were light-colored, matte, and flush with the surrounding skin enabling a lower score. Similarly, Bodyweight change was also significantly different in the two groups. Group B seemed to catch the 15th percentile of the normal weight-for-age curve, while Group A stayed at the 3rd percentile. This could be attributed to the facilitation in swallowing in Group B because the NAM plate acted as an obturator of the cleft. With an intact palate early on, the babies could probably adapt to the normal pattern of swallowing. The patients of Group B reportedly showed improved feeding amounts and frequency.
Another important benefit of the NAM technique is in the subsequent lip surgery enabling a precise repair. Logically, restoring the normal anatomy of the maxillary segments presurgically allows lip repair under less tension., In Group B patients, the cleft width was reduced and the position of the premaxilla was improved. The surgery was less demanding with less dissection of the nasal structures. As the alveolar segments' position improved, the normal arch form was established. If the esthetic outcome is improved, this is a powerful incentive to adopt presurgical infant orthopedic procedures.
Santiago et al. noted that with preferable positioning of alveolar segments and increased bony bridges across the cleft, the chance of properly positioned eruption of the permanent teeth has increased due to adequate periodontal support. Importantly, 60% of patients who had NAM and primary gingivoperiosteoplasty did not need secondary alveolar bone grafting. Thus, the use of the NAM technique is warranted to reduce passively the width of the alveolar gap while improving the AP discrepancy. Other advantages, namely straightening of the nasal septum, normalization of the deglutition process, prevention of twisting and positioning of the tongue in the cleft, and healthier speech development, are reported in the recent literature.,
Disadvantages mentioned in the literature include maxillary growth restriction, negative influences on speech because of delayed palate closure, the costs of the treatment, and its complexities. Grayson et al. stated that NAM without coordinated primary nasal surgical correction does not sufficiently correct a deformity of the nasal tip., Millard et al. reported a higher incidence of anterior crossbite in the presurgical orthopedics and periosteoplasty with lip adhesion group but a lower incidence of buccal crossbite than control.
Hotz and Gnoinski described fewer anterior and canine crossbites with delayed surgery, in comparison with McNiel-type orthopedic treatment with conventional surgery. However, Huddart found that, at the age of 5 years, the patient groups (with and without infant orthopedics) were comparable regarding the number of teeth in crossbite and the severity of the crossbite. Both dental malocclusion and maxillary hypoplasia can result in an anterior crossbite. Dental malocclusion can be treated by orthodontics, whereas marked midface hypoplasia requires orthognathic surgery. All the patients across both groups in our study showed initial resistance to the device but adapted to the plate very quickly. Transient irritation was observed again when the nasal stent was added. Only one patient of Group B developed cheek dermatitis, probably allergic to the adhesive of surgical adhesive tapes. It was quickly resolved by topical application of Calamine lotion.
One of the limitations of our study is the restricted number of cases (n = 20). Availability and affordability of NAM plates may increase the cases in the future.
| Conclusion|| |
As far as our small series is concerned, presurgical NAM has a positive impact on the surgical outcome of cleft lip. We endorse that presurgical NAM has a superior surgical outcome, reduces the need for revision surgeries later gives psychological reassurance to parents, and reduces the overall cost of treatment. Considering our result and recent literature, we warrant that different NAM techniques based on institutional practice and proper counseling of parents have great psychosocial satisfaction of the cleft lip family.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
- Prof. Rup Narayan Bhattacharya [MS, M.Ch], Head of the Department, Department of Plastic and reconstructive surgery, R. G. Kar Medical College, Kolkata, India
- Dr. Bidyut Debnath [MS, M.Ch, DNB, FRCS (Ed)], Professor and Head, Department of Pediatric Surgery, Dr. B.C.Roy, PGIPS, Kolkata, India.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Rossell-Perry P, Olivencia-Flores C, Delgado-Jimenez MP, Ormeño-Aquino R. Surgical nasoalveolar molding: A rational treatment for bilateral cleft lip nose and systematic review. Plast Reconstr Surg Glob Open 2020;8:e3082.
Chou PY, Hallac RR, Ajiwe T, Xie XJ, Liao YF, Kane AA, et al.
The role of nasoalveolar molding: A 3D Prospective analysis. Sci Rep 2017;7:9901.
Maillard S, Retrouvey JM, Ahmed MK, Taub PJ. Correlation between nasoalveolar molding and surgical, aesthetic, functional and socioeconomic outcomes following primary repair surgery: A systematic review. J Oral Maxillofac Res 2017;8:e2.
Abdulrauf BM. An ultimate method for cleft nasal deformity correction at primary lip surgery: Innovative concepts and review. Arch Oral Maxillofac Surg 2020;3:36-49.
Altuğ AT. Presurgical nasoalveolar molding of bilateral cleft lip and palate infants: An orthodontist's point of view. Turk J Orthod 2017;30:118-25.
Kapadia H, Olson D, Tse R, Susarla SM. Nasoalveolar molding for unilateral and bilateral cleft lip repair. Oral Maxillofac Surg Clin North Am 2020;32:197-204.
Bhattacharya S, Khanna V, Kohli R. Cleft lip: The historical perspective. Indian J Plast Surg 2009;42 Suppl:S4-8.
Oliveira NV, Tou GA, Silva RS, Rezende SE, Pretti H, Macari S. The first-year follow-up of a cleft lip and palate patient treated with nasoalveolar molding (NAM). Braz Dent J 2020;31:190-6.
Gandedkar NH, Kiat CC, Kanesan P, Lee WC, Chen PY, Yeow VK. Presurgical nasoalveolar molding therapy in cleft lip and palate individuals: Case series and review. APOS Trends Orthod 2015;5:208-14. [Full text]
Sruthi S, Sivakumar A, Pandian KS, Navaneethan R. Knowledge, awareness, and attitude on cleft lip and palate management among dental students. Drug Invent Today 2018;10:2608-13.
Shetye P, Grayson B. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. Semin Orthod 2017;23:261-7.
Subramanian CS, Prasad NK, Chitharanjan AB, Liou EJ. A modified presurgical orthopedic (nasoalveolar molding) device in the treatment of unilateral cleft lip and palate. Eur J Dent 2016;10:435-8.
] [Full text]
Shkoukani MA, Chen M, Vong A. Cleft lip – A comprehensive review. Front Pediatr 2013;1:53.
Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg 1998;102:1954-61.
Rani A, Thakur S, Devashish, Diwana VK, Chauhan T, Sharma KD. Modified presurgical NAM: A comparative clinical evaluation in complete unilateral left lip and palate management. Sch J Dent Sci 2020;7:127-32.
Subramanyam D. An insight of the cleft lip and palate in pediatric dentistry – A review. J Dent Oral Biol 2020;5:1164-9.
Bongaarts CA, Kuijpers-Jagtman AM, van 't Hof MA, Prahl-Andersen B. The effect of infant orthopedics on the occlusion of the deciduous dentition in children with complete unilateral cleft lip and palate (Dutchcleft). Cleft Palate Craniofac J 2004;41:633-41.
Monasterio L, Ford A, Gutiérrez C, Tastets ME, García J. Comparative study of nasoalveolar molding methods: Nasal elevator plus Dyna Cleft® versus NAM-Grayson in patients with complete unilateral cleft lip and palate. Cleft Palate Craniofac J 2013;50:548-54.
Lautner N, Raith S, Ooms M, Peters F, Hölzle F, Modabber A. Three-dimensional evaluation of the effect of nasoalveolar molding on the volume of the alveolar gap in unilateral clefts. J Craniomaxillofac Surg 2020;48:141-7.
Attiguppe PR, Karuna YM, Yavagal C, Naik SV, Deepak BM, Maganti R, et al
. Presurgical nasoalveolar molding: A boon to facilitate the surgical repair in infants with cleft lip and palate. Contemp Clin Dent 2016;7:569-73.
] [Full text]
Agarwal A, Rana V, Shafi S. A feeding appliance for a newborn baby with cleft lip and palate. Natl J Maxillofac Surg 2010;1:91-3.
] [Full text]
Grayson BH, Maull D. Nasoalveolar molding for infants born with clefts of the lip, alveolus, and palate. Clin Plast Surg 2004;31:149-58, vii.
Rubin MS, Clouston S, Ahmed MM, M Lowe K, Shetye PR, Broder HL, et al.
Assessment of presurgical clefts and predicted surgical outcome in patients treated with and without nasoalveolar molding. J Craniofac Surg 2015;26:71-5.
Millard DR, Latham R, Huifen X, Spiro S, Morovic C. Cleft lip and palate treated by presurgical orthopedics, gingivoperiosteoplasty, and lip adhesion (POPLA) compared with previous lip adhesion method: A preliminary study of serial dental casts. Plast Reconstr Surg 1999;103:1630-44.
Berkowitz S, Mejia M, Bystrik A. A comparison of the effects of the Latham-Millard procedure with those of a conservative treatment approach for dental occlusion and facial aesthetics in unilateral and bilateral complete cleft lip and palate: Part I. Dental occlusion. Plast Reconstr Surg 2004;113:1-18.
Niranjane PP, Kamble RH, Diagavane SP, Shrivastav SS, Batra P, Vasudevan SD, et al.
Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian J Plast Surg 2014;47:293-302.
] [Full text]
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]