DISCUSSION
Discussion on: Nasoalveolar Molding Therapy for the Treatment of Unilateral Cleft Lip and Palate Improves Nasal Symmetry and Maxillary Alveolar Dimensions Michael Alperovich, MD, Lawrence E. Brecht, DDS, and Stephen M. Warren, MD, FACS
I
n their article entitled ‘‘Nasoalveolar molding therapy for the treatment of unilateral cleft lip and palate improves nasal symmetry and maxillary alveolar dimensions’’ Ruı´z-Escolano et al1 report their analysis of 20 consecutive patients with unilateral cleft lip and palate treated with nasoalveolar molding therapy (NAM). The authors find improvements in a half dozen different nasal symmetry measurements as well as an improvement in all maxillary alveolar dimensions, an increase in the alveolar rim width and shape of the maxillary dental arch, and, finally, a reduction in the size of alveolar cleft gap. The authors are to be commended for their thoroughness in analyzing numerous parameters of nasal and dentoalveolar forms. Furthermore, as circulating maternal estrogens peak in the first 3 weeks of a life, it is impressive that, in a country as large as Spain, the mean age for starting NAM therapy was at day 10 of life.2 Since its initial description, NAM has been controversial.3 While the article by Ruı´z-Escolano et al1 adds to the scores of articles documenting the improvement in nasal symmetry, tip projection, columellar length, and the reduction in the dentoalveolar gap width, etc., critics have lamented the lack of randomization, blinding, anthropomorphic/anthropometric analyses, and inadequately powered studies.4,5 The litany of criticisms may be valid, but they can also be applied to nearly every other treatment offered in cleft surgery. For example, randomized assignment to receive or not to receive NAM is, in principle, an excellent idea. In practice, randomization is not possible. For example, randomizing patients within a given center would require patients to consent to the possibility of not receiving NAM. In the authors’ experience few patients would agree to the possibility of not receiving NAM when other patients in that center are receiving the treatment. Since only 37% of cleft centers in the United States offer NAM, cluster randomizing centers to provide or not to provide NAM would be impractical because it would require centers offering NAM to potentially stop offering it and would simultaneously require centers that do not provide NAM to possibly provide it.5 Nasoalveolar molding therapy is a technically demanding treatment and, therefore, it is technician-dependent. Variability in experience among orthodontists/prosthodontists at different centers would undoubtedly lead to substantial noise around the mean.6 To compound the inter-operator variability in NAM treatment, surgeons choose different surgical techniques. So to compare an From the Department of Plastic Surgery, NYU Langone Medical Center, New York, NY. Received August 31, 2016. Accepted for publication September 1, 2016. Address correspondence and reprint requests to Stephen M. Warren, MD, FACS, 875 Park Avenue, New York, NY 10075; E-mail: [email protected] The authors report no conflicts of interest. Copyright # 2016 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000003232
NAM-treated patient with an anatomic lip repair and primary nasal surgery to a non-NAM-treated patient with a nonanatomic Randall– Tennison lip repair and no/limited primary nasal surgery would be comparing apples to oranges. Moreover, blinding patients and treatment providers to NAM or no NAM is obviously impractical. A more practical approach to comparing cleft treatment programs would be to standardize the outcome measures. As the authors did in this study, in addition to adopting standardized anthropometric measures as described by Barillas et al, investigators could agree upon a standardized nasolabial appearance scoring system as well as a validated patient-reported outcome measure such as the Cleft-Q.7,8 By standardizing our assessments, we can more accurately make comparisons between different treatment programs and can improve the power to detect difference by conducting meta-analyses. While randomized, prospective, double-blind controlled trials are lacking and standardized outcome measures have not been agreed upon, we should not discount the importance of the dozens of studies demonstrating improved nasal symmetry and reduced alveolar gaps prior to cleft repair.4 When presented with pre- and post-NAM photographs, cleft surgeons consistently prefer operating on the post-NAM patients. As the plastic surgery group from the University of Pittsburgh wrote, ‘‘lack of definitive evidence for improved outcomes with nasoalveolar molding must not be equated with a lack of efficacy.’’6 Beyond the immediate advantages in the initial cleft repair, NAM affords multiple other benefits to the patient. When the alveolar gap is closed, gingivoperiosteoplasty is possible at the time of cleft repair, which can reduce the need for future alveolar bone grafting.9 Improved preoperative symmetry can lead to an improved postoperative aesthetic nasal result and an overall reduction of lifetime revisionary procedures reducing patient morbidity and total healthcare expenditures.10 Finally, as outlined by Ruı´z-Escolano et al, NAM empowers patients’ families to be actively involved in their child’s cleft care. Parents feel that they are contributing to their child’s clinical result. In a recent study, NAM did not unduly influence caregivers’ views of their infants over time.11 Overall, Ruı´z-Escolano et al performed a carefully planned and well-executed analysis of the benefit of NAM on preoperative nasal symmetry. Although there are limited high-level studies evaluating this procedure, over 100 heterogeneous studies exist validating the positive impact of NAM of which this study is the latest addition.
REFERENCES 1. Ruı´z-Escolano MG, Martı´nez-Plaza A, Ferna´ndez-Valade´s R, et al. Nasoalveolar molding therapy for the treatment of unilateral cleft lip and palate improves nasal symmetry and maxillary alveolar dimensions. J Craniofac Surg 2016;27:1978–1982 2. Doft MA, Goodkind AB, Diamond S, et al. The newborn butterfly project: a shortened treatment protocol for ear molding. Plast Reconstr Surg 2015;135:577e–583e
1983 Copyright © 2016 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery
Volume 27, Number 8, November 2016
Alperovich et al
The Journal of Craniofacial Surgery
3. Grayson BH, Cutting C, Wood R. Preoperative columella lengthening in bilateral cleft lip and palate. Plast Reconstr Surg 1993;92:1422–1423 4. Grayson BH. Discussion: limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:75e–76e 5. van der Heijden P, Dijkstra PU, Stellingsma C, et al. Limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:62e–71e 6. Smith DM, Macisaac ZM, Losee JE. Discussion: limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:72e–74e 7. Barillas I, Dec W, Warren SM, et al. Nasoalveolar molding improves long-term nasal symmetry in complete unilateral cleft lip-cleft palate patients. Plast Reconstr Surg 2009;123:1002–1006
Volume 27, Number 8, November 2016
8. Wong KW, Forrest CR, Goodacre TE, et al. Measuring outcomes in craniofacial and pediatric plastic surgery. Clin Plast Surg 2013;40:305– 312 9. Dec W, Shetye PR, Davidson EH, et al. Presurgical nasoalveolar molding and primary gingivoperiosteoplasty reduce the need for bone grafting in patients with bilateral clefts. J Craniofac Surg 2013;24:186–190 10. Patel PA, Rubin MS, Clouston S, 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;26:1229–1233 11. Broder HL, Flores RL, Clouston S, et al. Surgeon’s and caregivers’ appraisals of primary cleft lip treatment with and without nasoalveolar molding: a prospective multicenter pilot study. Plast Reconstr Surg 2016;137: 938–945
# 2016 Mutaz B. Habal, MD 1984 Copyright © 2016 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
Discussion on: Nasoalveolar Molding Therapy for the Treatment of Unilateral Cleft Lip and Palate Improves Nasal Symmetry and Maxillary Alveolar Dimensions Michael Alperovich, MD, Lawrence E. Brecht, DDS, and Stephen M. Warren, MD, FACS
I
n their article entitled ‘‘Nasoalveolar molding therapy for the treatment of unilateral cleft lip and palate improves nasal symmetry and maxillary alveolar dimensions’’ Ruı´z-Escolano et al1 report their analysis of 20 consecutive patients with unilateral cleft lip and palate treated with nasoalveolar molding therapy (NAM). The authors find improvements in a half dozen different nasal symmetry measurements as well as an improvement in all maxillary alveolar dimensions, an increase in the alveolar rim width and shape of the maxillary dental arch, and, finally, a reduction in the size of alveolar cleft gap. The authors are to be commended for their thoroughness in analyzing numerous parameters of nasal and dentoalveolar forms. Furthermore, as circulating maternal estrogens peak in the first 3 weeks of a life, it is impressive that, in a country as large as Spain, the mean age for starting NAM therapy was at day 10 of life.2 Since its initial description, NAM has been controversial.3 While the article by Ruı´z-Escolano et al1 adds to the scores of articles documenting the improvement in nasal symmetry, tip projection, columellar length, and the reduction in the dentoalveolar gap width, etc., critics have lamented the lack of randomization, blinding, anthropomorphic/anthropometric analyses, and inadequately powered studies.4,5 The litany of criticisms may be valid, but they can also be applied to nearly every other treatment offered in cleft surgery. For example, randomized assignment to receive or not to receive NAM is, in principle, an excellent idea. In practice, randomization is not possible. For example, randomizing patients within a given center would require patients to consent to the possibility of not receiving NAM. In the authors’ experience few patients would agree to the possibility of not receiving NAM when other patients in that center are receiving the treatment. Since only 37% of cleft centers in the United States offer NAM, cluster randomizing centers to provide or not to provide NAM would be impractical because it would require centers offering NAM to potentially stop offering it and would simultaneously require centers that do not provide NAM to possibly provide it.5 Nasoalveolar molding therapy is a technically demanding treatment and, therefore, it is technician-dependent. Variability in experience among orthodontists/prosthodontists at different centers would undoubtedly lead to substantial noise around the mean.6 To compound the inter-operator variability in NAM treatment, surgeons choose different surgical techniques. So to compare an From the Department of Plastic Surgery, NYU Langone Medical Center, New York, NY. Received August 31, 2016. Accepted for publication September 1, 2016. Address correspondence and reprint requests to Stephen M. Warren, MD, FACS, 875 Park Avenue, New York, NY 10075; E-mail: [email protected] The authors report no conflicts of interest. Copyright # 2016 by Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000003232
NAM-treated patient with an anatomic lip repair and primary nasal surgery to a non-NAM-treated patient with a nonanatomic Randall– Tennison lip repair and no/limited primary nasal surgery would be comparing apples to oranges. Moreover, blinding patients and treatment providers to NAM or no NAM is obviously impractical. A more practical approach to comparing cleft treatment programs would be to standardize the outcome measures. As the authors did in this study, in addition to adopting standardized anthropometric measures as described by Barillas et al, investigators could agree upon a standardized nasolabial appearance scoring system as well as a validated patient-reported outcome measure such as the Cleft-Q.7,8 By standardizing our assessments, we can more accurately make comparisons between different treatment programs and can improve the power to detect difference by conducting meta-analyses. While randomized, prospective, double-blind controlled trials are lacking and standardized outcome measures have not been agreed upon, we should not discount the importance of the dozens of studies demonstrating improved nasal symmetry and reduced alveolar gaps prior to cleft repair.4 When presented with pre- and post-NAM photographs, cleft surgeons consistently prefer operating on the post-NAM patients. As the plastic surgery group from the University of Pittsburgh wrote, ‘‘lack of definitive evidence for improved outcomes with nasoalveolar molding must not be equated with a lack of efficacy.’’6 Beyond the immediate advantages in the initial cleft repair, NAM affords multiple other benefits to the patient. When the alveolar gap is closed, gingivoperiosteoplasty is possible at the time of cleft repair, which can reduce the need for future alveolar bone grafting.9 Improved preoperative symmetry can lead to an improved postoperative aesthetic nasal result and an overall reduction of lifetime revisionary procedures reducing patient morbidity and total healthcare expenditures.10 Finally, as outlined by Ruı´z-Escolano et al, NAM empowers patients’ families to be actively involved in their child’s cleft care. Parents feel that they are contributing to their child’s clinical result. In a recent study, NAM did not unduly influence caregivers’ views of their infants over time.11 Overall, Ruı´z-Escolano et al performed a carefully planned and well-executed analysis of the benefit of NAM on preoperative nasal symmetry. Although there are limited high-level studies evaluating this procedure, over 100 heterogeneous studies exist validating the positive impact of NAM of which this study is the latest addition.
REFERENCES 1. Ruı´z-Escolano MG, Martı´nez-Plaza A, Ferna´ndez-Valade´s R, et al. Nasoalveolar molding therapy for the treatment of unilateral cleft lip and palate improves nasal symmetry and maxillary alveolar dimensions. J Craniofac Surg 2016;27:1978–1982 2. Doft MA, Goodkind AB, Diamond S, et al. The newborn butterfly project: a shortened treatment protocol for ear molding. Plast Reconstr Surg 2015;135:577e–583e
1983 Copyright © 2016 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
The Journal of Craniofacial Surgery
Volume 27, Number 8, November 2016
Alperovich et al
The Journal of Craniofacial Surgery
3. Grayson BH, Cutting C, Wood R. Preoperative columella lengthening in bilateral cleft lip and palate. Plast Reconstr Surg 1993;92:1422–1423 4. Grayson BH. Discussion: limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:75e–76e 5. van der Heijden P, Dijkstra PU, Stellingsma C, et al. Limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:62e–71e 6. Smith DM, Macisaac ZM, Losee JE. Discussion: limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg 2013;131:72e–74e 7. Barillas I, Dec W, Warren SM, et al. Nasoalveolar molding improves long-term nasal symmetry in complete unilateral cleft lip-cleft palate patients. Plast Reconstr Surg 2009;123:1002–1006
Volume 27, Number 8, November 2016
8. Wong KW, Forrest CR, Goodacre TE, et al. Measuring outcomes in craniofacial and pediatric plastic surgery. Clin Plast Surg 2013;40:305– 312 9. Dec W, Shetye PR, Davidson EH, et al. Presurgical nasoalveolar molding and primary gingivoperiosteoplasty reduce the need for bone grafting in patients with bilateral clefts. J Craniofac Surg 2013;24:186–190 10. Patel PA, Rubin MS, Clouston S, 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;26:1229–1233 11. Broder HL, Flores RL, Clouston S, et al. Surgeon’s and caregivers’ appraisals of primary cleft lip treatment with and without nasoalveolar molding: a prospective multicenter pilot study. Plast Reconstr Surg 2016;137: 938–945
# 2016 Mutaz B. Habal, MD 1984 Copyright © 2016 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
