Latham, working with the anatomist James Scott in England, went to Ontario, Canada, to become an orthodontist and be involved in cleft treatment. He soon developed a presurgical orthopedic appliance held in place by pins into the palate. Its mechanics were very efficient and quickly moved the laterally distorted palatal segments into a normal anatomic relationship. He continued his procedure at Duke University16 and then went to Miami to work with D. Ralph Millard, Jr. at The University of Miami School of Medicine. Millard started with lip adhesion followed by the Latham appliance and added an alveolar periosteoplasty hoping to replace the need for a secondary alveolar bone graft. Although there were no outcome studies from Canada or Duke, Millard still wished all cleft surgery to be completed earlier than was previously done. The new treatment plan with presurgical orthopedics, periosteoplasty, and lip adhesion (POPLA)17 was used for 20 years.
Because of my reluctance to use the untested procedure, another orthodontist in Miami performed the manipulation of the palatal segments, whereas I took extensive serial records of casts, cephs, and photographs as well as performing the later orthodontia for 20 years. A comparative study by Berkowitz et al16 followed to compare it with the conservative protocol previously described. The results clearly showed that POPLA led to severe facial and occlusal distortions. In both complete unilateral cleft lip and palate and complete bilateral cleft lip and palate (CBCLP), the resulting midface recessiveness with an anterior crossbite became more severe over time. Computerized tomography scans and periapical films of CBCLP cases showed a synostatic premaxillary vomerine suture changes with solid bone uniting the retruded premaxilla to the vomer. The closed alveolar cleft space became occupied with the solid bone preventing the opening of the lateral incisor space. This outcome study was the only comparative POPLA longitudinal treatment study published on the use of neonatal premaxillary orthopedics in complete unilateral cleft lip and palate and CBCLP cases. Unfortunately other surgeons, both Mulliken and Cutting, who had also used POPLA for many years, have failed to perform their own facial and occlusal outcome studies as well.
After 15 years, Cutting discontinued POPLA’s use and joined with Grayson, an orthodontist at NYU, to introduce a modification of POPLA calling it nasoalveolar molding (NAM) with a removable appliance and a gingivoperiosteoplasty (GPP).19,20 The removable palatal appliance carried an extended stent to contact the premaxilla hoping to stimulate columella size. Their palatal appliance was found to accomplish one of its goals of bodily retracting the premaxilla to create an aesthetic lip and nose during the neonatal period. They only reported aesthetic lip/nose results avoiding any developing occlusal comments but fortunately a serial cephaloradiographic study of the NAM + GPP procedure from Taiwan21 reported severe midfacial recessiveness. No similar comparative cast, ceph, or photographic study has been published by Cutting and Grayson since its inception. Unfortunately, none of the surgeons who adopted the NAM + GPP treatment procedure reported their occlusal/profile outcome studies either.
WHAT WE LEARNED
My 40-year serial clinical records of more than 400 patients from birth through adolescence of all cleft types with conservative treatment have shown that varied surgical staged treatment procedures were necessary to achieve good treatment results with all treatment goals to be reached at least by 7 to 8 years of age.
Current methods of treatment favor staged treatment, ie, closing the lip cleft in 2 stages: the first year and the palate at a later age usually between 18 and 24 months8 or sometimes earlier, or even later, depending on the 15% to 20% ratio of cleft to palate size. Doing so offers a more encouraging prognosis than that of the surgeons who closed the palatal cleft before 1 year, a practice that has prevailed for the last 50 years. This finding was determined by a Multicenter International serial cast study from the South Florida Cleft Palate Clinic, the University of Illinois College of Dentistry Cleft-Craniofacial Clinic and Northwestern University Craniofacial Clinic in the United States, the University of Goteborg in Sweden, the University of Amsterdam, and the University of Nijmegen in the Netherlands. The age of the patient and the type of surgery to be applied are the 2 variables needed in determining the long-term effect of surgery on facial growth. Quantitative and qualitative characteristics of the cleft defect, plus the general health and genotype (facial growth pattern) of the individual patient, are additional determining factors that affect outcome results. Under certain conditions, surgical repair of the palate is feasible quite early, at about 1 year of age, when the cleft space is very small with good posterior occlusion. In others, as already stated, optimal conditions for repair will not become evident until a later age to reduce cleft size and encourage good palatal growth (Fig. 11).
The pattern of progress in dealing with the sequence of scientific advances with the evolution of diagnosis and therapy in cleft lip and palate is excellent. Although the literature on facial clefts can be traced back for several centuries, it is principally concerned with surgical and prosthetic rehabilitation. Furthermore, such therapy in the recent past was based largely on empiricism and reflected no real understanding of the morphology and pathophysiology. Reconstructive procedures were rarely founded on an intimate knowledge of the embryology and comparative anatomy of the region involved.
These criticisms do not imply that surgery for cleft lip and palate is in a state of chaotic disorganization. As in all branches of surgery, plastic reconstruction of the face has benefited from advances in all of the sciences. Indeed, plastic repair of the face reflects some of our most imaginative and skillful surgery and has produced remarkable cosmetic and functional results. Nevertheless, it is only in recent years that we have noted attempts to classify and delineate clinical entities among the large variety of anomalies that comprise the complex of cleft lip and palate, and only recently we have begun to make full use of the new radiographic techniques, cephs, and dental casts to study palate size, position, and function in the oropharyngeal region. The accumulation of longitudinal data to describe the natural history of facial anomalies during postnatal development and the effects of various modes of therapy is still in progress. Our understanding of the developmental processes in the formation of the face is adequate to explain the variety of problems encountered and their varying patterns of postnatal development.
As the relationship between speech, facial growth, the timing of palatal surgery, and the use of presurgical orthopedics to bodily retract the premaxilla, the reliance on clinical insight and upon case reports that lack independent documentation of results, still prevails. On the one hand, one must commend the continuing and indeed zealous pursuit of this critical question: Are serial records necessary? On the other hand, we must ask whether there is a way to increase the relative proportion of reliable, valid data and decrease the dependence on undocumented opinion.
A bilateral cleft of the lip and palate can be complete or incomplete on 1 or both sides. Any number of variations can exist in all cleft types, and the size and shape of the premaxilla is dependent on the number of tooth buds and their distribution making it symmetrical or asymmetrical. Because clefts of the lip/alveolus and the hard and soft palate come from different embryological sources, the cleft may involve the lip and alveolus with or without involving the hard and soft palate.
A critical review of the literature on the clinical management of the cleft lip and cleft palate, together with an evaluation of the cumulative palatal and cleft size data from longitudinal palatal growth studies, has led most orthodontists to the following hypothesis: conservative lip and palatal surgery facilitates rather than inhibiting growth in both the maxillofacial skeletal complex and the soft tissue of the labio-facial complex. In the cleft palate cases, operative intervention that involved bone growth potential will guide maxillofacial growth in the individual in such a way that postoperative “catch up” growth of the palate will result in acceptably normal development (Fig. 12).
Most facial and palatal skeletal malformations in cleft patients are the result of surgical procedures that cause some growth retardation or there are osteogenic deficiencies that lead to maxillary hypoplasia. All maxillary discrepancies are 3 dimensional, and bone size relative to cleft size at the time of surgery is crucial.
Differences between surgeons, variance in the performance by the same surgeon from day to day, and during the course of several years, and differences in techniques that are difficult to identify and compare, complicate the analysis. However, the research objectives to test the influence of presurgical orthopedic treatment and the relationship of cleft palate space to surgical outcome can be reached. It is possible to statistically test and covary for effects because of difference between and within surgeons.
The facial and palatal natural history of children with clefts and those with specific syndromes demonstrates that some improve over time, some grow worse, and others remain unchanged despite the surgical effort. Presurgical orthopedics to bodily retrude the premaxilla by “telescoping” it, except for the use of a facial elastic to ventroflex the premaxilla to aid the surgeon before uniting the lip, have no long-term utility. Primary bone grafting at the neonatal period also has a deleterious effect on future palatal and facial growth.
These findings show that within certain defined limits, the success or failure of the surgical procedure depends on the initial state and the variables inherent in the maneuver. Subtle differences among patients will be prognostic of the subsequent state and the differences between surgeons. No matter what type of treatment surgeons have favored, they have not been able to explain why their surgical method of choice, when performed on similar clefts at the same age, often yielded different results. Why some cases appear to show “catch-up growth” resulting in good facial and palatal form and functional dental occlusion, whereas others show poor facial and palatal development?
If we assume that qualified surgeons within a given institution or region, practicing a specific series of techniques over a given period of time represent a constant, the differences in success or failure should reside in (1) the initial state (the geometric and size relationship of the palatal segments to the size and shape of the cleft space, which reflects the degree of palatal-skeletal deficiency and palatal segment displacement) and (2) the facial growth pattern. Of course, the sample must separate cases, subjected to or not subjected to presurgical maxillary orthopedics, as well as cases utilizing various cleft closure procedures, because these variables can influence the subsequent state.
Cleft palate surgery is best performed between 18 and 24 months or later if the ratio of the cleft space to the palatal soft tissue medial to the alveolar ridges is greater than 15%.7
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Copyright © 2016 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Plastic Surgeons. All rights reserved.
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