Evaluating SWAG and Its Validity When Compared to 3D Imagery of Secondarily Grafted Cleft Sites.

OBJECTIVE: To test validity of 2D Standardized Way to Assess Grafts (SWAG) ratings to assess 3D outcomes of bone grafting (ABG). PATIENTS: 43 patients (34 UCLP, 9 BCLP) with non-syndromic complete clefts, bone-grafted at mean age 9yrs/3mos, with available post-graft occlusal radiographs and cone beam computed tomography (CBCT) (taken mean 4yrs/9mos post-ABG). MAIN OUTCOME MEASURES: 2D occlusal radiographs rated twice using SWAG by 6 calibrated raters. 12 scores were averaged and converted to a percentage reflecting bone-fill. Weighted Kappas were assessed for SWAG reliability. 3D cleft-site bone volume was calculated by 1 rater using ITK-SNAP. 13 cleft sites were re-measured by the 'one rater' for 3D reliability using Intraclass Correlation Coefficient (ICC). 2D versus 3D ratings were compared using paired t-test, independent samples t-test, Bland-Altman and Linear Regression. Significance level was P = .5. RESULTS: 2D reliability was 0.724 (intra-rater) and 0.546 (inter-rater). 3D reliability was 0.986. Bland-Altman plot comparing 2D vs 3D showed for 45 of 47 graft-sites were within 2 SD's. Mean % bone-fill was 64.11% with 2D and 69.06% with 3D (mean difference = 4.95%) that was a non-significant difference in both t-tests. Regression showed a statistically significant relation between the two methods (r2 = 0.46; P = .0001). CONCLUSION: 2D SWAG systematically and non-significantly underestimated bone-fill. There was a significant correlation between 2D/3D methods. Bland-Altman analysis illustrated the similarity of the two methods. For comparisons of group (cleft treatment Centers') bone grafting outcomes, the 2D method may suffice as a proxy for the 3D method. However, with individual variation up to 40% in 2D estimates of actual 3D volume, 2D SWAG method cannot be used in place of 3D images.

Early Secondary Alveolar Bone Grafting and Facial Growth of Patients with Complete Unilateral Cleft Lip and Palate.

OBJECTIVE: To investigate the craniofacial growth outcomes of early secondary alveolar bone grafting(ABG) around 6 years of age. DESIGN: Retrospective cohort study. SETTING: 1 North-American and 5 Northern-European cleft centers. SUBJECTS: 33 subjects with CUCLP consecutively treated with secondary ABG around 6 years of age were compared to 105 subjects from 4 centers treated with late secondary ABG and 19 subjects from 1 center with primary ABG. METHODS: Preorthodontic standardized lateral cephalometric radiographs taken after 12 years of age were traced and analyzed according to the Eurocleft Study protocol. Fourteen angular and two proportional measurements were performed. Measurement means from the Study Center(SC) were compared to 5 Northern-European centers using analysis of variance and Welch's modified t-tests, and P < .05 was considered statistically significant. RESULTS: For the SC, the mean age ± SD at the time of bone graft was 5.85 ± 0.71 years and the mean age at the time of the lateral cephalogram was 13.4 ± 1.8 years. The sagittal maxillary prominence of the SC was favorably comparable to the 5 Northern-European centers. The mean SNA (78.1 ± 4.3) for the SC was significantly higher compared to 4 of the 5 Northern-European centers(all P < .05), and the mean ANB angle was comparable to 4 of the 5 centers. Similarly, the mean soft tissue ANB angle was not significantly different to the 5 centers. The soft tissue vertical proportions compared favorably to all 5 Northern-European centers(all P < .01). CONCLUSIONS: Craniofacial growth outcomes of early secondary ABG around 6 years compare favorably to the outcomes of late secondary ABG.

The Effect of Earlier Bone Grafting, Prior to Orthodontic Treatment, on SWAG Ratings of Graft Outcomes.

OBJECTIVE: To compare the outcomes between 2 groups of patients with complete clefts treated with early secondary alveolar bone grafting (ABG) at 2 centers (5-7 years, before orthodontic intervention) and to a third group of patients treated at one of those centers (center 1) who had received later secondary ABG (8-10 years, after orthodontic intervention). DESIGN: Blind retrospective analysis of cleft site radiographs using Americleft Standardized Way to Assess Grafts (SWAG) scale. PATIENTS: A total of 99 patients with complete clefts from 2 North American cleft/craniofacial centers. INTERVENTIONS: Secondary ABG representing 2 protocols: early grafting at a mean age of 6.6 years prior to any orthodontic intervention, and later grafting at a mean age of 10.2 years following pregrafting orthodontic intervention. MAIN OUTCOME MEASURES: Using occlusal radiographs, the SWAG scale from 0 (failed graft) to 6 (ideal) was used. Six trained, calibrated raters scored each radiograph twice, with the average of the 2 ratings used as the final score. Reliability was assessed using the weighted κ statistic. The significance of differences between groups was determined using the Kruskal-Wallis test and Dunn test for pairwise comparisons. RESULTS: Inter-rater reliability of SWAG method was good (0.631). Intra-rater reliability was excellent (0.817). There was a tendency for improved total graft outcome in the early grafted group from center 1 compared to the later grafted group with improvement being significantly different in only the coronal third of the early, preorthodontic grafted group. However, the difference was not statistically significant for the graft overall.

Facial Growth of Patients With Complete Unilateral Cleft Lip and Palate Treated With Alveolar Bone Grafting at 6 Years.

OBJECTIVE: To investigate the effect that alveolar bone grafting (ABG) around 6 years of age has on facial growth by assessing craniofacial growth outcomes. DESIGN: Retrospective cohort study. SETTING: North American cleft centers. PARTICIPANTS: A total of 33 children with complete unilateral cleft lip and palate who were consecutively treated with secondary ABG around 6 years of age were compared to 148 participants from 4 centers with late secondary ABG. METHODS: Preorthodontic standardized lateral cephalometric radiographs were analyzed and traced according to the Americleft Study protocol. Sixteen angular and 2 proportional measurements were performed. The outcomes of all ABG were assessed using the Standardized Way to Assess Graft scale. Measurement means from the study center (SC) were compared to 4 North American centers using analysis of variance and Welch modified t tests, and P < .05 was considered statistically significant. RESULTS: For the SC, the mean age (SD) at the time of bone graft was 5.85 (0.71) years and the mean age at the time of the lateral cephalogram was 13.4 (1.8) years. The sagittal maxillary prominence of the SC was comparable to the 4 other centers. The mean SNA (78.1 [4.3]) for the SC was significantly higher compared to one center that used primary bone grafting ( P = .03). The soft tissue mean ANB (3.52 [4.09]) for the SC was significantly lower compared to 3 of the centers. CONCLUSIONS: Early secondary ABG around 6 years of age did not result in reduced midface projection as assessed by SNA and thus did not compromise anterior maxillary growth.

Burden of Care of Various Infant Orthopedic Protocols for Improvement of Nasolabial Esthetics in Patients With CUCLP.

OBJECTIVES: 1. To evaluate the orthodontic burden of care of nasoalveolar molding (NAM) and modified McNeil for the treatment of patients with complete unilateral cleft lip and palate (CUCLP). 2. To compare the esthetic outcomes of each with those of centers not utilizing infant orthopedics (IO). DESIGN: Retrospective cohort study. SETTING: Institutional. PARTICIPANTS: Four cohorts with repaired CUCLP (n = 149) from 3 centers. INTERVENTIONS: Two cohorts were treated in the same center and had either traditional infant orthopedics (TIO) or NAM and 2 were treated in centers not employing IO. MAIN OUTCOME MEASURES: Burden of care data for the IO groups were compared using t tests. Frontal and profile photographs at approximately age 5 were collected for ratings of nasolabial esthetics, using a modification of the Asher-McDade method. Intrarater and interrater reliabilities were determined using weighted κ statistics. Median ratings were compared using a Kruskal-Wallis test. RESULTS: The burden of care of NAM was significantly greater than TIO for both the number of visits (9.9 vs 6.6, [ P < .001]); and treatment duration (127 vs 112 days, [ P < .05]). Significant differences in nasolabial esthetic ratings were noted among the 3 centers. No significant differences were observed in the nasolabial esthetic outcomes between the NAM and TIO groups. CONCLUSIONS: 1. NAM required more visits and longer overall duration compared with TIO. 2. The center employing IO showed favorable nasolabial esthetics compared to those not utilizing IO. 3. No significant differences were found in the nasolabial esthetics of patients who have received NAM compared with TIO.

The Americleft Project: Comparison of Ratings Using Two-Dimensional Versus Three-Dimensional Images for Evaluation of Nasolabial Appearance in Patients With Unilateral Cleft Lip and Palate.

This study was conducted to determine if nasolabial appearance is rated with comparable results and reliability on 3-dimensional stereophotogrammetric facial images versus standard clinical photographs (2-dimensional). Twenty-seven consecutively treated patients with repaired complete unilateral cleft lip and palate were selected. Six trained and calibrated raters assessed cropped 2- and 3-dimensional facial images. Nasolabial profile, nasolabial frontal, and vermillion border esthetics were rated with the 5-point scale described by Asher-McDade using the modified Q-sort method. Cropped 3-dimensional images were available for viewing by each rater, allowing for complete rotational control for viewing the images from all aspects. Two- and three-dimensional ratings were done separately and repeated the next day.Interrater reliability scores were good for 2-dimensional (κ = 0.607-0.710) and fair to good for 3-dimensional imaging (κ = 0.374-0.769). Intrarater reliability was good to very good for 2-dimensional (κ = 0.749-0.836) and moderate to good for 3-dimensional imaging (κ = 0.554-0.855). Bland-Altman analysis showed satisfactory agreement of 2- and 3-dimensional scores for nasolabial profile and nasolabial frontal, but more systematic error occurred in the assessment of vermillion border.Although 3-dimensional images may be perceived as more representative of a direct clinical facial evaluation, their use for subjective rating of nasolabial aesthetics was not more reliable than 2-dimensional images in this study. Conventional 2-dimensional images provide acceptable reliability while being readily accessible for most cleft palate centers.

The Americleft Project: Plaster Dental Casts Versus Digital Images for GOSLON Yardstick Ratings When Used in Intercenter Comparisons.

The purpose of this investigation was to determine reliability and validity of GOSLON Yardstick ratings using plaster casts versus photo galleries of digital images in actual intercenter comparisons. The dental arch relationships of 112 patients with complete unilateral cleft lip and palate from 3 North American cleft/craniofacial centers were rated in 2 separate studies. In the first, plaster casts were used. For a later intercenter comparison, the same dental casts were scanned, digital bases added, and two-dimensional photographic galleries (6 views) were created for each set of casts. Three raters experienced with the GOSLON Yardstick carried out 2 separate ratings of the plaster casts in the first study, then of the photographic gallery of scanned digital images of the same casts in the second study. Inter- and intrarater reliabilities were calculated using the Weighted Kappa statistic. Average scores for each patient were calculated and compared between methods with correlation statistics and a Bland-Altman plot. Kruskal-Wallis test was used to compare results between centers using both media. Reliability using both methods was very good and comparable between methods. Mean weighted Kappas were: inter-rater = 0.815 (plaster) versus 0.891 (photo); and intrarater = 0.866 (plaster) versus 0.891 (photo). There was a highly significant correlation (r = 0.920). Mean difference between centers was 0.033 of a GOSLON category. The level of significance of the differences found between centers with both methods was identical, confirming the interchangeability of both media presentations.

Evaluation of objective structured clinical examination for advanced orthodontic education 12 years after introduction.

INTRODUCTION: Advanced education programs in orthodontics must ensure student competency in clinical skills. An objective structure clinical examination has been used in 1 program for over a decade. The results were analyzed cross-sectionally and longitudinally to provide insights regarding the achievement of competency, student growth, question difficulty, question discrimination, and question predictive ability. METHODS: In this study, we analyzed 218 (82 first-year, 68 second-year, and 68 third-year classes) scores of each station from 85 orthodontic students. The grades originated from 13 stations and were collected anonymously for 12 consecutive years during the first 2 decades of the 2000s. The stations tested knowledge and skills regarding dental relationships, analyzing a cephalometric tracing, performing a diagnostic skill, identifying cephalometric points, bracket placement, placing first-order and second-order bends, forming a loop, placing accentuated third-order bends, identifying problems and planning mixed dentition treatment, identifying problems and planning adolescent dentition treatment, identifying problems and planning nongrowing skeletal treatment, superimposing cephalometric tracings, and interpreting cephalometric superimpositions. Results were evaluated using multivariate analysis of variance, chi-square tests, and latent growth analysis. RESULTS: The multivariate analysis of variance showed that all stations except 3 (analyzing a cephalometric tracing, forming a loop, and identifying cephalometric points) had significantly lower mean scores for the first-year student class than the second- and third-year classes (P <0.028); scores between the second- and third-year student classes were not significantly different (P >0.108). The chi-square analysis of the distribution of the number of noncompetent item responses decreased from the first to the second years (P <0.0003), from the second to the third years (P <0.0042), and from the first to the third years (P <0.00003). The latent growth analysis showed a wide range of difficulty and discrimination between questions. It also showed continuous growth for some areas and the ability of 6 questions to predict competency at greater than the 80% level. CONCLUSIONS: Objective structure clinical examinations can provide a method of evaluating student performance and curriculum impact over time, but cross-sectional and longitudinal analyses of the results may not be complementary. Significant learning appears to occur during all years of a 3-year program. Valuable questions were both easy and difficult, discriminating and not discriminating, and came from all domains: diagnostic, technical, and evaluation/synthesis.

Overview of orthodontic care for children with cleft lip and palate, 1915-2015.

The purpose of this article is to review and discuss the advances in the management of children born with cleft lip and palate (CLP) as it has evolved over the past 100 years. This overview is based on articles published in the American Journal of Orthodontics, which frequently changed its name, over the past century. Additionally, other journals will be cited as craniofacial anomalies became recognized during the 20th century and the biologic basis became refined, with the new discipline of genetics replacing the term hereditary and its connotations of eugenics. The Human Genome Project, completed in 2003, has now provided an understanding of syndromic and nonsyndromic CLP that has led to advances in the diagnosis and treatment of CLP in the 21st century. These evolving concepts will be discussed in an overview of the types of procedures published from 1915 to 2015 and the major transition in the mid-20th century from multiple uncoordinated interventions from various specialists to a coordinated team approach in which the orthodontist has a specific role in the timing and sequencing of interdisciplinary treatment goals. Major technologic advancements in treatment modalities and the contemporary approach to the health-related quality of life of the patient and the caregiver have resulted in their participation in treatment options and decisions. The requirement of informed consent reflects the legal doctrine that now emphasizes the ethical imperative of greater respect for patient autonomy in the decision-making process. The orthodontist no longer makes decisions alone, but rather with the team and the patient or the caregiver.

The Americleft Project: Burden of Care from Secondary Surgery.

BACKGROUND: The burden of care for children with cleft lip and palate extends beyond primary repair. Children may undergo multiple secondary surgeries to improve appearance or speech. The purpose of this study was to compare the use of secondary surgery between cleft centers. METHODS: This retrospective cohort study included 130 children with complete unilateral cleft lip and palate treated consecutively at 4 cleft centers in North America. Data were collected on all lip, palate, and nasal surgeries. Nasolabial appearance was rated by a panel of judges using the Asher-McDade scale. Risk of secondary surgery was compared between centers using the log-rank test, and hazard ratios estimated with a Cox proportional hazards model. RESULTS: Median follow-up was 18 years (interquartile range, 15-19). There were significant differences among centers in the risks of secondary lip surgery (P < 0.001) and secondary rhinoplasty (P < 0.001). The cumulative risk of secondary lip surgery by 10 years of age ranged from 5% to 60% among centers. The cumulative risk of secondary rhinoplasty by 20 years of age ranged from 47% to 79% among centers. No significant differences in nasolabial appearance were found between children who underwent secondary lip or nasal surgery and children who underwent only primary surgery (P > 0.10). CONCLUSIONS: Although some cleft centers were significantly more likely to perform secondary surgery, the use of secondary surgery did not achieve significantly better nasolabial appearance than what was achieved by children who underwent only primary surgery.

Restraint stress alters the expression of interleukin-1 and keratinocyte growth factor at the wound site: an in situ hybridization study.

Stress has a negative impact on wound healing. This murine study evaluated the effect of restraint stress (RST) on interleukin-1 (IL-1) and keratinocyte growth factor-1 (KGF-1) gene expression in cutaneous wounds by in situ hybridization. At day 1, RST mice had reduced frequency of IL-1beta mRNA-expressing fibroblasts compared to control mice. At day 3, RST mice had reduced frequencies of IL-1beta mRNA-expressing leukocytes, KGF-1 mRNA-expressing fibroblasts, and thin proliferating zones of epithelium. At day 5, RST mice had persistent leukocytic foci and reduced granulation tissue. Therefore, stress-induced alterations in cutaneous proinflammatory cytokine and growth factor expression are associated with significant histological changes in healing wounds.

Altered kinetics of IL-1 alpha, IL-1 beta, and KGF-1 gene expression in early wounds of restrained mice.

Inflammatory processes that occur after injury contribute to wound closure. Previous studies showed that wounds of restraint-stressed (RST) mice had a reduced number of inflammatory cells and healed more slowly compared to controls. To investigate the molecular mechanisms between stress and wound healing, we studied cutaneous gene expression of IL-1 alpha, IL-1 beta, and KGF-1. Female SKH-1 mice were restrained for 3 days before and for 5 days following placement of cutaneous wounds. Wounds were subjected to competitive RT-PCR. At day 1, RST mice had significantly lower IL-1 beta and KGF-1 mRNA than controls. At day 5, RST mice had significantly higher IL-1 alpha and IL-1 beta mRNA than controls. Treatment of RST mice with the glucocorticoid receptor antagonist RU486 restored IL-1 beta mRNA expression at day 1. Our results suggest that stress induces alterations in the kinetics of cutaneous proinflammatory cytokine and growth factor gene expression which could impair the quality of healing tissues.