This study compared craniofacial morphology between three groups of children with complete unilateral cleft lip and palate, treated with different surgical protocols. The study included 66 10-year-old children (42 boys and 20 girls) with a complete unilateral cleft lip and palate (22 patients in each of the three groups). Children aged 7 months underwent one-stage surgery, performed by a single surgeon. During surgery, the soft and hard palate and the lip underwent correction. The difference between the groups depended on the hard palate closure. Group I patients had the mucoperiosteal flap elevated on both sides of the cleft. Group II patients had the mucoperiosteal flap elevated on the non-cleft side, and had only a minimal 2–3 mm mucoperiosteal flap elevated on the cleft side. Group III patients had mucoperiostium elevated from the septum vomer to create a single-layered caudally pedicled flap, and had only a minimal 2–3 mm palatal flap elevated on the cleft side. Craniofacial morphology was defined using lateral cephalometric analysis. Significant craniofacial morphological differences were identified between groups I, II and III. Group III demonstrated the most favourable morphology. This indicates that the technique of hard palate closure has significant influence on craniofacial growth and development.
Treatment of children with complete unilateral cleft lip and palate employs different surgical protocols. Shaw demonstrated that in 201 European centers treating cleft disorders; 194 different surgical protocols were used. All protocols involve various surgical techniques, patient age, sequence of lip, soft and hard palate closure, and treatment with presurgical maxillary orthopedics and orthodontics. A comparison of the treatment results achieved by different centers would be valuable for cleft disorder studies. Several papers have investigated craniofacial morphology in children with cleft disorders, but there are only a handful of cross-center trials indicating the impact of different surgical protocols on craniofacial growth and development. A large number of different surgical treatment techniques and varied assessment criteria impede the formulation of an optimum treatment method.
The aim of this study was to compare craniofacial morphology in children with complete unilateral cleft lip and palate treated by three different surgical protocols. Comparative studies were devised to determine elements of particular surgical protocols with the highest impact on future results in the treatment of cleft disorders.
Materials and methods
The study protocol was reviewed and approved by the Research Review Board and Ethical Scientific Board of National Research Institute for Mother and Child. The study was performed at the National Research Institute for Mother and Child, Center of Craniofacial Disorders. The study group comprised 66 children patients with complete unilateral cleft lip and palate who underwent surgical treatment from 1981 to 1992. The study material included 66 lateral radiographs and clinical documentation that contributed to identification of the type of cleft.
In the years 1981–1992, the same basic surgical treatment protocol had been used in all cases. From 1981 until 1985, the protocol consisted of non presurgical orthopedics and the one-stage operation at about 7 months. The one-stage operation consisted of lip repair with triangular flaps, closure of the hard palate according to the bilateral von Langenbeck procedure and closure of the soft palate with three layers. Since 1986 the protocol has only been changed regarding hard palate closure. The authors started using the unilateral von Langenbeck procedure, then after 1990, hard palate closure using a single-layered caudal-pedicled vomer flap was introduced. One-stage surgery for cleft lip and palate closure was performed by the same surgeon (ZD). All patients were 7 months old.
As a result of modification of the surgical palate closure technique, the patients were separated into three homogenous groups, with 22 patients in each group ( Table 1 ). Group I patients had the mucoperiosteal flap elevated from both sides of the cleft (bilateral von Langenbeck palatoplasty; Fig. 1 ). Group II patients had the mucoperiosteal flap separated only from the non-cleft side (unilateral von Langenbeck palatoplasty; Fig. 2 ). Lateral relaxation incisions were closed during the von Langenbeck procedure as much as possible, so the denudated bone was seldom left exposed. Group III patients had the mucoperiostium elevated from the septum vomer to create a single-layered caudal-pedicled flap, and only minimal 2–3 mm palatal flap elevation on the cleft side ( Fig. 3 ). Treatment of all cases involved the same lip closure using triangular flaps.
The study was expanded with patients from the Centre of Craniofacial Disorders database who met the following criteria: complete cleft lip and palate (patients with Simonard’s band were excluded); absence of additional syndromes and psychiatric illness; absence of presurgical orthopedics and current orthodontic treatment; all patients were operated on by the same surgeon (ZD); assessed lateral cephalography was undertaken between the age of 9 years 6 months and 10 years 6 months.
In group I, 22 of 54 patients with complete unilateral cleft lip and palate treated by the above-mentioned protocol between 1981 and 1985 (16 male, 6 female) fulfilled the inclusion criteria. Surgery was performed at 7.4 months of age. Hard palate closure was performed using mucoperiosteal flap elevation on both sides of the cleft (bilateral von Langenbeck palatoplasty).
In group II, 22 of 64 patients with complete unilateral cleft lip and palate treated by the protocol between 1986 and 1990 (14 male, 8 female) met the inclusion criteria. Surgery was performed at the age of 7.2 months. Hard palate closure was performed by means of mucoperiosteal flap elevation on the non-cleft side (unilateral von Langenbeck palatoplasty).
In group III, 22 of 38 patients with complete unilateral cleft lip and palate treated with the protocol from 1990 to 1991 (16 male, 6 female) met the inclusion criteria. Surgery was performed at the age of 7.3 months. These patients had the mucoperiostium elevated from the septum vomer to create a single-layered caudal-pedicled flap, and only minimal 2–3 mm palatal flap elevation on the cleft side.
Lip and soft palate closure techniques were the same in all groups. All groups were subjected to the same elements of the surgical protocol, with the sole exception of the hard palate closure technique.
Craniofacial morphology was evaluated from a lateral cephalogram taken at 10 years of age. Radiographic analysis was performed by one person (MK) on Kefalo orthodontic software (version 3.5; Kefalo Orthodontic Software; Ostrava; Czech Republic), with 0.1 mm and 0.1° resolution. Radiographs were entered into the computer database using a Hewlett-Packard 6100C optic scanner. Prior to reference point digitalization on the computer screen using the mouse, radiographic calibration was carried out on the computer screen. Craniofacial morphology was identified using a lateral cephalogram carried out at the age of 10 years (between 9 years and 6 months and 10 years and 6 months). The analysis covered reference points and Steiner’s cephalometric analysis. Each lateral cephalogram was evaluated twice, the final result being the mean value of two measurements. Figure 4 depicts the reference points. 10 points per cephalogram were identified and 20 variables parameters (10 angular and 10 linear) were calculated at each registration using Kefalo 3.5 cephalometric software. All linear parameters referred to the length of the anterior cranial fossa.
The control group comprised 22 non-orthodontically treated non-cleft patients from the same population (14 boys, 8 girls) with Class I occlusion, matched according to age and gender. All data were compared with normal values first, then the parameters were compared among the three groups to highlight differences in craniofacial morphology caused by the specific type of hard palate surgery.
The cephalometric measurement error (Dahlberg’s method— SE = ( SD 2 /2 n ) −1/2 ) was calculated where D was the difference between two measurements and n the number of evaluated radiographs.
Variance analysis (Student’s t- test) was used to compare the average value generated by cephalometric measurements. Differences exceeding 0.05 were defined as statistically significant, p = 0.01 as particularly significant and p = 0.001 as extremely significant.
To determine the sensitivity of the method, each parameter was measured twice. Double cephalometric analysis of 20 cephalograms indicated that the method error for angular measurements ranged from 0.3° to 0.75° (mean 0.525°), and for linear measurements from 0.15 to 0.70 mm (mean 0.425 mm). Discrepancy s(i)2 measurement error for all researched variables was under 3%. This indicated that the method was sufficiently accurate with respect to morphological descriptive differences between the groups studied. A higher method error was revealed for the parameters N-ANS and N-A, probably due to difficulties with precise positioning of ANS point on the lateral cephalogram.
Cephalometric parameter comparison analysis determining cranial morphology demonstrated significant differences between groups I, II, and III. Table 2 shows the results of the cephalometric analysis and a combined comparison of particular groups and the non-cleft sample.
|Group I||Group II||Group III||Non-cleft|
|1 + NS||88.09||6.83||84.70||7.00||85.60||6.51||102.5||6.6||***||***||***||NS||NS||NS|