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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 8  |  Issue : 1  |  Page : 35-40

A comparative assessment of secondary surgeries between nasoalveolar molding-treated and non nasoalveolar molding-treated patients with unilateral cleft lip and palate


Department of Oral and Maxillofacial Surgery, Smile Train Clinic, Bhagwan Mahavir Jain Hospital, Bengaluru, Karnataka, India

Date of Submission06-Oct-2020
Date of Acceptance17-Nov-2020
Date of Web Publication13-Jan-2021

Correspondence Address:
Dr. Tulasi Nayak
Department of Oral and Maxillofacial Surgery, Smile Train Clinic, Bhagwan Mahavir Jain Hospital, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jclpca.jclpca_36_20

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  Abstract 


Introduction: Secondary surgeries are a commonly documented element of cleft treatment. It adds to the surgical and economic burden of care. Nasoalveolar molding (NAM) is one of the techniques which has gained popularity as it has proven to reduce the pre surgical severity. NAM has also been proposed to reduce the need for future secondary surgeries. In this retrospective study, we aimed to compare the incidence of secondary surgeries in NAM treated and non-NAM-treated patients with unilateral cleft lip and palate (UCLP). Methods: In this retrospective study, all consecutively treated NAM and non-NAM patients with UCLP who had undergone primary surgeries in 2011–2013 were considered. Only those patients who had a complete clinical and surgical record at 5 years of age were included for this study. Thirty-eight patients in NAM group and 48 patients in non-NAM group were compared. All patients had received the same protocol with the exception of NAM. The cleft severity index was used to check the preoperative cleft severity. The type of lip defect was described for all patients who had received the secondary surgery. Results: Pre NAM clefts were found to be more severe than the non-NAM group. However, after the NAM therapy, the cleft severity was less than the non-NAM group. Non-NAM group had a statistically higher number of lip revision surgeries with a broader variety of defects than the NAM group. There was no statistically significant difference for the Fistula closures. Conclusion: NAM reduced the cleft severity at the pre surgical stage. At 5 years of follow-up, NAM-treated patients had a lower surgical burden of care in comparison to the non-NAM-treated patients.

Keywords: Burden of care, cleft lip and palate, nasoalveolar molding, revision surgery, secondary surgeries, unilateral


How to cite this article:
Nayak T, Krishnamurthy B, Parmar R, Shetty PN. A comparative assessment of secondary surgeries between nasoalveolar molding-treated and non nasoalveolar molding-treated patients with unilateral cleft lip and palate. J Cleft Lip Palate Craniofac Anomal 2021;8:35-40

How to cite this URL:
Nayak T, Krishnamurthy B, Parmar R, Shetty PN. A comparative assessment of secondary surgeries between nasoalveolar molding-treated and non nasoalveolar molding-treated patients with unilateral cleft lip and palate. J Cleft Lip Palate Craniofac Anomal [serial online] 2021 [cited 2021 Jan 26];8:35-40. Available from: https://www.jclpca.org/text.asp?2021/8/1/35/306775




  Introduction Top


All patients with unilateral cleft lip and palate (UCLP) undergo multiple interventions including surgeries, orthodontics, and speech therapy. Secondary surgeries are also a common part of the treatment.[1],[2],[3],[4],[5],[6] As the patient experiences the primary surgeries early in life, it is important that the treating team perform the best treatment in the first attempt; reduce the magnitude of the secondary deformities and finally the number of secondary procedures. Pre surgical nasoalveolar molding (NAM)[7] is one of the methods proposed for reducing the pre surgical cleft severity[8],[9],[10],[11],[12] and the future necessity for secondary surgeries.[11],[13],[14],[15]

In this retrospective study, we aimed to assess and compare the need for and the type of secondary surgeries in NAM-treated and non-NAM-treated patients with UCLP at 5 years' follow-up.


  Methods Top


This research was conducted per the Helsinki Declaration. In this retrospective study, all consecutively treated NAM and non-NAM patients with UCLP who had undergone primary surgeries in 2011–2013 were considered. Only those patients who had a complete clinical and surgical record at 5 years of age were included for this study. Patients with incomplete clefts and other craniofacial anomalies were excluded from this study. All infants who had arrived at the center before 6 weeks of age were treated with Eric Liou's technique[16] of NAM for an average of 4 months. All patients were treated with Modified Millard's cheiloplasty at an average age of 6 months of age without primary rhinoplasty or gingivoperiosteoplasty [Table 1]. One stage palatoplasty was done with Bardach's technique with repositioning of the soft palate musculature at an average of 1 year of age [Table 1]. All the surgeries were done by the same two surgeons. No rhinoplasty had been performed on any of the patients during the follow-up period. Lip revision was performed using Millard's principles and palatal fistula closure with local flaps was performed on patients who warranted the procedures. The final study group consisted of 86 consecutively treated patients with UCLP. Thirty-eight of the patients had received NAM and 48 of the patients had not received NAM. The NAM group consisted of 19 male and 19 female patients; the non NAM group consisted of 16 male and 32 female patients [Table 2]. As the original inclusion into the NAM and non-NAM groups were done without randomization, the pre NAM photos, post NAM photos, and non-NAM group photos were retrieved and graded on the cleft severity index scale[17] by a trained cleft surgeon who had been blinded. The index was designed for UCLP and graded patients from mild incomplete cleft lip (Grade 1) to severe complete cleft lip (Grade 4) based on the extent of severity of the lip and nasal defect. The records were then studied to compare the number of secondary surgeries in both the groups.
Table 1: Comparison of mean age for cheiloplasty and palatoplasty performed between two groups using Mann–Whitney test

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Table 2: Gender distribution between two study groups using Chi-square test

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Statistical analysis

Statistical package for social sciences (SPSS) for Windows, Version 22.0. Released in 2013. Armonk, NY, USA: IBM Corp., was used to perform statistical analyses.

The mean cheiloplasty age and palatoplasty age were compared between two groups using Mann–Whitney test [Table 1]. Chi-square test was used to compare the gender distribution and secondary surgeries. The comparison of mean scores of the cleft severity index between pre-NAM and non-NAM groups as well as the post-NAM and non-NAM groups was done using Independent Student's t-test. The comparison of mean scores of the cleft severity index between pre-NAM and non-NAM groups was done using the Student Paired t-test. The comparison of the varying grades of cleft severity index between pre-NAM and non-NAM groups as well as the post-NAM and non-NAM groups was done using Chi-square test. The comparison of the varying grades of cleft severity index between pre-NAM and post-NAM groups was done using the McNemar's Test. The level of significance (P Value) was set at P < 0.05.


  Results Top


In this retrospective study, the photographs of 38 consecutive NAM treated UCLP and 48 consecutive non-NAM treated UCLP were studied. There was no statistically significant difference found between the two groups with regards to the gender or age of primary surgeries.

On comparing the cleft severity index scale between the pre-NAM, post-NAM, and non-NAM groups.

Prenasoalveolar molding v/s nonnasoalveolar molding

On comparing the mean cleft severity index scores of the pre-NAM and non-NAM groups, the pre-NAM group (mean value - 3.89) has a statistically significant (P-0.03*) more severe cleft presentation than the non-NAM group (mean value - 3.67) [Table 3]. When the individual percentages are studied, the differences are statistically significant (P-0.01*). The pre-NAM has a lower percentage of patients (10.5%) with Grade 3 in comparison to the non-NAM group (33.3%). The pre-NAM has a higher percentage of patients (89.5%) with Grade 4 in comparison to the non-NAM group (66.7%) [Table 4].
Table 3: Comparison of mean scores of cleft severity index between prenasoalveolar molding and nonnasoalveolar molding groups using independent Student's t-test

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Table 4: Comparison of varying grades of cleft severity index between prenasoalveolar molding and nonnasoalveolar molding groups using Chi-square test

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Prenasoalveolar molding v/s postnasoalveolar molding

On comparing the mean cleft severity index scores of pre-NAM and post-NAM groups, the pre-NAM group (Mean value - 3.89) has a statistically significant (P-0.001*) more severe cleft presentation than the post-NAM group (mean value - 3.26) [Table 5]. When the individual percentages are studied, the differences are statistically significant (P-0.001*). The pre-NAM has a lower percentage of patients (10.5%) with Grade 3 in comparison to the Post-NAM group (73.3%). The pre-NAM has a higher percentage of patients (89.5%) with Grade 4 in comparison to the post-NAM group (26.3%) [Table 6].
Table 5: Comparison of mean scores of cleft severity index between pre nasoalveolar molding and post nasoalveolar molding groups using student paired t-test

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Table 6: Comparison of varying grades of cleft severity index between prenasoalveolar molding and postnasoalveolar molding group using McNemar's test

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Postnasoalveolar molding v/s nonnasoalveolar molding

On comparing the mean cleft severity index scores of post-NAM and non-NAM groups, the post-NAM group (mean value - 3.26) has a statistically significant (P-0.001*) less severe cleft presentation than the non-NAM group (mean value - 3.67) [Table 7]. When the individual percentages are studied, the differences are statistically significant (P-0.001*). The post-NAM has a higher percentage of patients (73.7%) with Grade 3 in comparison to the non-NAM group (33.3%). The post-NAM has a lower percentage of patients (26.3%) with Grade 4 in comparison to the non-NAM group (66.7%) [Table 8].
Table 7: Comparison of mean scores of cleft severity index between postnasoalveolar molding and nonnasoalveolar molding groups using Independent Student t-test

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Table 8: Comparison of varying grades of cleft severity index between post nasoalveolar molding and non nasoalveolar molding groups using Chi-Square test

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Secondary surgeries nasoalveolar molding group v/s nonnasoalveolar molding group

In the comparison between the NAM and non-NAM groups with regards to the number of secondary surgeries performed in each group, the number of lip revision was statistically higher in the non-NAM group (P-0.04*). 7.9% of the patients in the NAM group had undergone lip revision in comparison to the non NAM group where 25% underwent lip revisions. The number of fistula closure performed however had no statistically significant difference [Table 9].
Table 9: Comparison of different surgeries performed between two groups using Chi-Square test

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When further assessing the nature of the secondary lip deformity using the scale by Assuncao [Table 10],[18] we found that in the NAM group one patient exhibited notching at the site of the scar (V2) and one had a thick drooping lateral lip in the vermillion patterns (V5); two patients had a short lip (L1) and one had a bulge of the orbicularis oris in the lip patterns (L3). There were no patients with a deformity in the scar pattern. In contrast, the number of deformities was more in the non-NAM group. In the vermillion pattern, one patient exhibited thinning at the suture line and notching at the site of the scar (V1 and V2), one patient exhibited only a notching at the site of the scar (V2), one patient exhibited a notching at the site of the scar and a thin lateral lip (V2 and V4). One patient exhibited a notching at the site of the scar and a complete thinning of the vermillion of the upper lip including the noncleft side (V2 and V6), one patient exhibited only a thick drooping lateral lip in the vermillion patterns (V5), one patient exhibited only the whistling deformity (V3), one patient exhibited only the whistling deformity and an irregular vermillion border (V3 and V7), two patients exhibited a thin lateral lip (V4), one patient exhibited a thick drooping lateral lip in the vermillion patterns (V5), one patient exhibited only a complete thinning of the vermillion of the upper lip including the noncleft side (V6), one patient exhibited only an irregular vermillion border (V7). In the Lip patterns, eight patients exhibited only a short lip (L1) and one patient had a short lip as well as philtral damage with the scar invading the philtrum (L1 and L4). In the scar pattern two patients exhibited a wide scar (S1), one patient exhibited a scar which was wide only at the vermillion border (S2), one patient exhibited a hypertrophic scar (S3), one patient exhibited a depressed scar (S4), and one patient exhibited an irregular scar (S5).
Table 10: Lip deformity classified as per Assuncao 1992

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  Discussion Top


Secondary surgeries are frequently performed in cleft lip and palate patients.[19],[20],[21],[22] While the lip revision is typically performed in the preschool period before isolation or bullying by peers may take place, a fistula closure is performed when it is symptomatic.[20] The published rate of secondary deformities vary widely. The fistula closure rates vary between 0% and 70%.[1],[23],[24] The rate of lip revision vary between 4.5% and 24.7%[21] and even a rate of 45%[25] has been reported. The inter-center comparative study by Kornbluth et al.,[26] showed that 3% of the NAM treated patients had received lip revision in contrast to 8% of no PSIO group and 94% in the Latham appliance group. The centers however all had different surgical protocols and ages at which the revisions were performed. Comparing the results in cleft treatment is difficult due to the large number of confounding factors. This study is unique as both groups are similar except for the NAM treatment. This helps us discern the exclusive relation of NAM and secondary surgeries in UCLP.

In this retrospective study, two similarly treated groups of UCLP patients–one who had received NAM therapy and one who had not received NAM therapy were compared to assess the number of secondary surgeries. As the inclusion of the patients into the NAM and non-NAM groups was not randomized, the cleft severity index, a validated scale,[17] was used to determine the difference between the two groups in terms of the severity of the cleft. The index was designed for UCLP and graded patients from mild incomplete cleft lip (Grade 1) to severe complete cleft lip (Grade 4) based on the extent of severity of the lip and nasal defect. Using this scale, we found that the initial cleft severity in the pre-NAM group was higher than the non-NAM group. The NAM therapy helped reduce the preoperative severity of the NAM group. Hence, the final preoperative NAM severity was lesser than the non-NAM group. Apart from the NAM treatment, both the groups had received a similar treatment protocol. The comparison of the secondary surgeries showed us that the number of fistula closures was not statistically significant however, the number of lip revisions performed were statistically higher in the non-NAM group. Only 7.9% of the NAM treated patients had received lip revision in contrast to 25% of the non NAM patients who received it.

A large number of factors may be responsible for secondary deformities in the treated cleft.[6] The flap designs, the surgeon factors, preoperative width of the cleft may all individually or in combination cause secondary deformities. While the primary deficiency of tissue or inappropriate design of lip rotation, predisposes the shortening of lips in clefts; excessive width of the cleft makes it inevitable.[5] Poor scar presentations are also seen in cases where there is excessive cleft width, inadequate muscle release and tension across the suture line.[20] In the current study, all patients had received the same cheiloplasty and palatoplasty design, by the same two operative surgeons. While both groups had a similar rate of fistula occurrence, the non NAM patients had higher and more varied combinations of secondary lip deformities. Nine patients had short lips, four patients had notching at the site of the scar and six patients had unsightly scars. The preoperative cleft severity of the non-NAM group was higher than the NAM group and this could have probably predisposed these patients to the greater secondary deformities.

UCLP has no universally accepted protocol for treatment. Secondary procedures cause an increase in the number of visits, surgical costs, missed school days and lost wages for the parents.[6] Hence, it is important to minimize the number of secondary surgeries. In this study, we have found that NAM helps to not only reduce the preoperative cleft severity but at the 5-year postoperative period show lesser number of secondary lip procedures.

Limitations

The current study is a single-center report with a limited number of patients. The follow-up duration is short. The senior surgeons had achieved unpredictable results from primary rhinoplasty and had excluded it from the protocol. Hence, a scale which excluded the nasal scores was chosen.


  Conclusion Top


In the current study, we found that NAM reduced the pre surgical cleft severity. At the 5 year follow-up, NAM-treated patients had a lower surgical burden of care and lesser number of lip revision surgeries in comparison to the non–NAM-treated patients. The results are a short-term follow-up report and the patients will be followed up till the end of growth to determine the final need for secondary surgery.

Financial support and sponsorship

This funded research is the product of the “ISCLPCA Research Fellowship” for the year 2019 which was awarded to the First author by the Indian Society of Cleft Lip, Palate and Craniofacial Anomalies (ISCLPCA).

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Bardach J, Morris H, Olin W, McDermott-Murray J, Mooney M, Bardach E. Late results of multidisciplinary management of unilateral cleft lip and palate. Ann Plast Surg 1984;12:235-42.  Back to cited text no. 1
    
2.
Marsh JL. When is enough enough? Secondary surgery for cleft lip and palate patients. Clin Plast Surg 1990;17:37-47.  Back to cited text no. 2
    
3.
Cohen SR, Corrigan M, Wilmot J, Trotman CA. Cumulative operative procedures in patients aged 14 years and older with unilateral or bilateral cleft lip and palate. Plast Reconstr Surg 1995;96:267-71.  Back to cited text no. 3
    
4.
Trotman CA, Faraway JJ, Phillips C, van Aalst J. Effects of lip revision surgery in cleft lip/palate patients. J Dent Res 2010;89:728-32.  Back to cited text no. 4
    
5.
Stal S, Hollier L. Correction of secondary cleft lip deformities. Plast Reconstr Surg 2002;109:1672-82.  Back to cited text no. 5
    
6.
Sitzman TJ, Carle AC, Lundberg JN, Heaton PC, Helmrath MA, Trotman CA, et al. Marked variation exists among surgeons and hospitals in the use of secondary cleft lip surgery. Cleft Palate Craniofac J 2020;57:198-207.  Back to cited text no. 6
    
7.
Grayson BH, Cutting C. Presurgical nasoalveolar orthopedic molding in primary correction of the nose, lip, and alveolus of infants born with unilateral and bilateral clefts. Cleft Palate Craniofac J 2001;38:193-8.  Back to cited text no. 7
    
8.
Liou EJ, Subramanian M, Chen PK. Progressive changes of columella length and nasal growth after nasoalveolar molding in bilateral cleft patients: A 3-year follow-up study. Plast Reconstr Surg 2007;119:642-8.  Back to cited text no. 8
    
9.
Lee CT, Garfinkle JS, Warren SM, Brecht LE, Cutting CB, Grayson BH. Nasoalveolar molding improves appearance of children with bilateral cleft lip-cleft palate. Plast Reconstr Surg 2008;122:1131-7.  Back to cited text no. 9
    
10.
Barillas I, Dec W, Warren SM, Cutting CB, Grayson BH. Nasoalveolar molding improves long-term nasal symmetry in complete unilateral cleft lip-cleft palate patients. Plast Reconstr Surg 2009;123:1002-6.  Back to cited text no. 10
    
11.
Grayson BH, Garfinkle JS. Early cleft management: the case for nasoalveolar molding. Am J Orthod Dentofacial Orthop 2014;145:134-42.  Back to cited text no. 11
    
12.
Zuhaib M, Bonanthaya K, Parmar R, Shetty PN, Sharma P. Presurgical nasoalveolar moulding in unilateral cleft lip and palate. Indian J Plast Surg 2016;49:42-52.  Back to cited text no. 12
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13.
Pfeifer TM, Grayson BH, Cutting CB. Nasoalveolar molding and gingivoperiosteoplasty versus alveolar bone graft: An outcome analysis of costs in the treatment of unilateral cleft alveolus. Cleft Palate Craniofac J 2002;39:26-9.  Back to cited text no. 13
    
14.
Sischo L, Chan JW, Stein M, Smith C, van Aalst J, Broder HL. Nasoalveolar molding: Prevalence of cleft centers offering NAM and who seeks it. Cleft Palate Craniofac J 2012;49:270-5.  Back to cited text no. 14
    
15.
Patel PA, Rubin MS, Clouston S, Lalezaradeh F, Brecht LE, Cutting CB, et al. Comparative study of early secondary nasal revisions and costs in patients with clefts treated with and without nasoalveolar molding. J Craniofac Surg 2015;26:1229-33.  Back to cited text no. 15
    
16.
Chen PK, Noordhoff MS, Liou EJ. Treatment of complete bilateral cleft lip-nasal deformity. In: Seminars in Plastic Surgery. Germany: Thieme Medical Publishers; 2005. p. 329-342.  Back to cited text no. 16
    
17.
Campbell A, Restrepo C, Deshpande G, Bernstein SM, Tredway C, Wendby L, et al. Validation of the unilateral cleft lip severity index for surgeons and laypersons. Plast Reconstr Surg Glob Open 2017;5:e1479.  Back to cited text no. 17
    
18.
Assuncao AG. The V.L. Classification for secondary deformities in the unilateral cleft lip: Clinical application. Br J Plast Surg 1992;45:293-6.  Back to cited text no. 18
    
19.
Grewal NS, Kawamoto HK, Kumar AR, Correa B, Desrosiers AE 3rd, Bradley JP. Correction of secondary cleft lip deformity: The whistle flap procedure. Plast Reconstr Surg 2009;124:1590-8.  Back to cited text no. 19
    
20.
Monson LA, Khechoyan DY, Buchanan EP, Hollier LH Jr. Secondary lip and palate surgery. Clin Plast Surg 2014;41:301-9.  Back to cited text no. 20
    
21.
Sittah GA, Ghanem OA, Hamdan U, Ramia P, Zgheib E. Secondary cleft nasolabial deformities: A new classification system for evaluation and surgical revision. Cleft Palate Craniofac J 2018;55:837-43.  Back to cited text no. 21
    
22.
Peanchitlertkajorn S, Mercado A, Daskalogiannakis J, Hathaway R, Russell K, Semb G, et al. An intercenter comparison of nasolabial appearance including a center using nasoalveolar molding. Cleft Palate Craniofac J 2018;55:655-63.  Back to cited text no. 22
    
23.
Maeda K, Ojimi H, Utsugi R, Ando S. A T-shaped musculomucosal buccal flap method for cleft palate surgery. Plast Reconstr Surg 1987;79:888-96.  Back to cited text no. 23
    
24.
Senders CW, Sykes JM. Modifications of the Furlow palatoplasty (six- and seven-flap palatoplasties). Arch Otolaryngol Head Neck Surg 1995;121:1101-4.  Back to cited text no. 24
    
25.
Henkel KO, Gundlach K, Saka B. Incidence of secondary lip surgeries as a function of cleft type and severity: One center's experience. Cleft Palate Craniofac J 1998;35:310-2.  Back to cited text no. 25
    
26.
Kornbluth M, Campbell RE, Daskalogiannakis J, Ross EJ, Glick PH, Russell KA, et al. Active presurgical infant orthopedics for unilateral cleft lip and palate: Intercenter outcome comparison of Latham, modified Mcneil, and nasoalveolar molding. Cleft Palate Craniofac J 2018;55:639-48.  Back to cited text no. 26
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10]



 

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