Plastic Surgery Outreach Clinics Expand Access to Cleft and Craniofacial Care in Mississippi.

ABSTRACT: Accessing treatment at ACPA (American Cleft Palate-Craniofacial Association)-approved centers is challenging for individuals in rural communities. This study aims to assess how pediatric plastic surgery outreach clinics impact access for patients with orofacial cleft and craniosynostosis in Mississippi. An isochrone map was used to determine mean travel times from Mississippi counties to the sole pediatric hospital and the only ACPA-approved team in the state. This analysis was done before and after the establishment of two outreach clinics to assess differences in travel times and cost of travel to specialized plastic surgery care. Two sample t-tests were used for analysis.The addition of outreach clinics in North and South Mississippi led to a significant reduction in mean travel times for patients with cleft and craniofacial diagnoses across the state's counties (1.81 hours vs 1.46 hours, P < 0.001). Noteworthy travel cost savings were observed after the introduction of outreach clinics when considering both the pandemic gas prices ($15.27 vs $9.80, P < 0.001) and post-pandemic prices ($36.52 vs $23.43, P < 0.001).The addition of outreach clinics in Mississippi has expanded access to specialized healthcare for patients with cleft and craniofacial differences resulting in reduced travel time and cost savings for these patients. Establishing specialty outreach clinics in other rural states across the United States may contribute significantly to reducing burden of care for patients with clefts and craniofacial differences. Future studies can further investigate whether the inclusion of outreach clinics improves follow-up rates and surgical outcomes for these patients.

In-vivo assessment of application of folinic acid and botulinum toxin A in cleft lip surgical defects.

INTRODUCTION: Folinic acid and botulinum toxin A have shown promising results in wound healing in different studies. This study aimed to compare the effects of these approaches on wound healing after simulating cleft lip surgery in rats. METHODS: In this experimental animal study, after creating lip defects, 30 rats were randomly divided into three groups and received normal saline (CTL), botulinum toxin A (BOT), and folinic acid (FOL). Biopsy from the skin wounds was performed after 14- and 28-days. These samples were stained with haematoxylin and eosin and Masson trichrome staining. Finally, each pathological parameter of wound healing was rated in this study. RESULTS: While the inflammatory response was not different among the study groups, fibroblast proliferation and collagen deposition were significantly higher in FOL group compared to BOT group. Moreover, both BOT and FOL facilitated epithelial healing and 14-day angiogenesis as compared with normal saline. CONCLUSIONS: Improved wound healing was observed using both botulinum toxin A and folinic acid in rat animal models. However, the application of botulinum toxin A caused less fibroblast proliferation and collagen deposition which can potentially lead to less scar formation, which can be particularly important in the aesthetic zone.

Validation and comparison of 2D grading scales and 3D volumetric measurements for outcome assessment of bone-grafted alveolar clefts in children.

BACKGROUND: Several methods have been proposed to assess outcome of bone-grafted alveolar clefts on cone beam computed tomography (CBCT), but so far these methods have not been compared and clinically validated. OBJECTIVES: To validate and compare methods for outcome assessment of bone-grafted clefts with CBCT and provide recommendations for follow-up. METHODS: In this observational follow-up study, two grading scales (Suomalainen; Liu) and the volumetric bone fill (BF) were used to assess the outcome of 23 autogenous bone-grafted unilateral alveolar clefts. The mean age at bone grafting was 9 years. The volumetric BF was assessed in five vertical sections. The bone-grafted cleft outcome was based on a binary coding (success or regraft) on a clinical multidisciplinary expert consensus meeting. Grading scales and volumetric assessment were compared in relation to the bone-grafted cleft outcome (success or regraft). Reliability for the different outcome variables was analyzed with intra-class correlation and by calculating kappa values. LIMITATIONS: The study had a limited sample size. Clinical CBCT acquisitions had a varying tube current and exposure time. RESULTS: Volumetric 3D measurements allowed for outcome assessment of bone-grafted alveolar clefts with high reliability and validity. The two grading scales showed highly reliable outcomes, yet the validity was high for the Suomalainen grading scale but low for the Liu grading scale. CONCLUSIONS: Volumetric 3D measurement as well as the Suomalainen grading can be recommended for outcome assessment of the bone-grafted cleft. Yet, one must always make a patient-specific assessment if there is a need to regraft.

Most Efficient and Meaningful Patient-Reported Appearance Assessment in Different Cleft Types and Age Groups with CLEFT-Q.

BACKGROUND: The CLEFT-Q, a questionnaire developed and validated specifically for cleft patients, contains seven appearance scales. The International Consortium of Health Outcomes Measurement (ICHOM) has incorporated only some CLEFT-Q appearance scales in the Standard Set to minimize burden. This study evaluates which appearance scales provide the most meaningful information in the different cleft types at specific ages, for the most efficient cleft appearance outcome assessment. METHODS: Within this international multicenter study, outcomes of the seven appearance scales were collected, either as part of the ICHOM Standard Set, or as part of the field test study performed to validate the CLEFT-Q. Analyses were performed in separate age groups and cleft types, and involved univariate regression analyses, trend analyses, t tests, correlations, and floor and ceiling effects. RESULTS: A total of 3116 patients were included. Scores for most appearance scales showed a downward trend by age group, with the exception of the Teeth and Jaw scales. In all cleft types, several scales correlated strongly with each other. No floor effects were observed, but ceiling effects were found in several scales in different age groups, most often in the CLEFT-Q Jaw scale. CONCLUSIONS: A proposition for the most meaningful and efficient appearance outcome assessment in cleft patients is made. It was composed so that recommendations are of value for different cleft protocols and initiatives. Suggestions for the use of scales in the ICHOM Standard Set at different ages are given, and also from a clinical perspective. Use of the CLEFT-Q Scar, Lips, and Nose scales will provide additional relevant information.

Dental Protraction Versus Surgery for Cleft Lip and Palate: A Budget Impact Analysis.

Class III malocclusion for individuals with cleft lip and palate has historically been managed with surgery. Orthodontic protraction is a noninvasive alternative that may be associated with lower costs. This analysis investigated the budget impact of protraction versus surgery from an institutional perspective. Using a decision tree, analysis was conducted using costs derived from Medicaid reimbursement codes and using actual institutional reimbursement. Probabilities of success, failure, and complications were based on a clinical trial comparing the 2 treatment modalities. One-way and probabilistic sensitivity analyses tested the robustness of results to model parameters. Based on Medicaid fee schedules and failure rates requiring additional surgery, the total cost of protraction was $79,506 versus $172,807 for surgery, resulting in $93,302 cost-savings per patient. The cost and probability of surgery success, as well as the cost of surgery failure and repeat surgery, had the largest impact on these cost-savings. Probabilistic sensitivity analysis showed cost-savings of nearly $92,000 or higher in >50% of simulations. This study showed that protraction is associated with lower costs than surgery and may present a cost-effective alternative to surgery in eligible, appropriate patients.

Healthcare use and direct medical costs in a cleft lip and palate population: an analysis of observed and protocolized care and costs.

This study was performed to describe observed healthcare utilization and medical costs for patients with a cleft, compare these costs to the expected costs based on the treatment protocol, and explore the additional costs of implementing the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set for Cleft Lip and Palate (CL/P). Forty patients with unilateral CL/P between 0 and 24 years of age, treated between 2012 and 2019 at Erasmus University Medical Center, were included. Healthcare services (consultations, diagnostic and surgical procedures) were counted and costs were calculated. Expected costs based on the treatment protocol were calculated by multiplying healthcare products by the product prices. Correspondingly, the additional expected costs after implementing the ICHOM Standard Set (protocol + ICHOM) were calculated. Observed costs were compared with protocol costs, and the additional expected protocol + ICHOM costs were described. The total mean costs were highest in the first year after birth (€5596), mainly due to surgeries. The mean observed total costs (€40,859) for the complete treatment (0-24 years) were 1.6 times the expected protocol costs (€25,198) due to optional, non-protocolized procedures. Hospital admissions including surgery were the main cost drivers, accounting for 42% of observed costs and 70% of expected protocol costs. Implementing the ICHOM Standard Set increased protocol-based costs by 7%.

Knowledge assessment on cleft lip and palate among recently graduated dentists: a cross-sectional study.

BACKGROUND: The complex presentation, associated co-morbidities and multi-disciplinary requirements dictate the requirement for in-depth knowledge in order to effectively manage patients with cleft lip and palate (CLP). We aimed to develop a validated questionnaire for cleft lip and palate knowledge assessment and to evaluate the knowledge of cleft lip and palate among a group of recently-graduated dentists. MATERIALS AND METHODS: A multiple-site, cross-sectional questionnaire-based study was conducted. The study population included recently graduated dentists involved in a dental internship program. A bespoke questionnaire was developed and validated, with internal consistency assessed using Cronbach's alpha and factor analysis performed. A 47-item prototype was distilled into a 15-item questionnaire. This was distributed to the participants with a response rate of 67% obtained. RESULTS: The overall proportion of correct responses among dental interns was moderate (73%). The best results were found in relation to CLP treatment including the effect of unfavorable surgical outcomes on speech (89.5%) and the impact of CLP on the occlusion (87.6%). The lowest rate of correct responses (26.7%) was identified in relation to the association between CLP and smoking. CONCLUSION: A validated CLP questionnaire was developed, permitting evaluation of the knowledge of cleft lip and palate and its management among recently graduated dentists. There is limited appreciation among dental interns of the risk factors for CLP as well as post-surgical complications. Given that general dentists are often the gatekeepers for the management of patients with cleft lip and palate, it is important that the findings of this survey are used to inform the curriculum and teaching of cleft lip and palate.

Volumetric assessment of the nose after primary unilateral cleft rhinoplasty using Laberge's technique.

BACKGROUND: There is a lack of standardized surgery for cleft rhinoplasty. We felt that the technique described by Dr Louise Caouette Laberge is an ideal way to approach this problem, thus we tried to quantify the outcome of surgery by volumetric assessment. MATERIAL AND METHOD: We recorded 3D images using an Artec scanner and performed volume calculations of the cleft side and noncleft side of the nose. These readings were taken once in the preoperative and then 2 weeks postoperative. Another scan of the face was performed 2 years after the surgery to compare the volumes of the cleft and noncleft side nostril. RESULTS: Of the 31 patients with unilateral cleft lip operated on (mean age 3-8 months), we found a significant increase in the cleft side volume at 3 weeks postoperative from 3.95 mm3 to 5.65 mm3 (p < 0.001 on paired t-test). A repeat scan done on the study population at 2 years postoperative found that the mean volume of the cleft side was 30.43 mm3 (standard deviation [SD], 2.49) and that of the normal side was 30.82 mm3 (SD, 2.51). An independent t-test found that there was no significant difference between the two volumes (p > 0.05) CONCLUSION: The use of volumetric data in the evaluation of postoperative outcomes provides an objective criterion for assessing the aesthetics as well as the growth. Our study concludes that the Laberge technique provides a good aesthetic outcome with minimal scarring for the management of cleft nose and lip with the anterior palate.

Associations Between Medicaid Expansion and Timely Repair of Cleft Lip and Palate.

The expansion of Medicaid under the Affordable Care Act (ACA) increased access to health care for many low-income children. However, the impact of this expansion on the timing of primary cleft lip and palate repair remains unclear. This study aimed to evaluate whether Medicaid expansion improved access to timely cleft lip and palate repair and whether it reduced preexisting ethnoracial disparities. Using a quasi-experimental design, the study analyzed data from 44 pediatric surgical centers across the United States. The results showed that Medicaid expansion was associated with a 9.0 percentage-point increase in delayed cleft lip repairs, resulting in an average delay of 16 days. Non-White patients were disproportionately affected by this delay, experiencing a 14.8 percentage-point increase compared with a 4.9 percentage-point increase for White patients. In contrast, Medicaid expansion had no significant effect on the timing of palate repair or on ethnoracial disparities in palate repair. The study underscores the importance of monitoring unintended consequences of large-scale health system changes, especially those affecting disadvantaged populations. Delayed cleft lip repair can lead to worse outcomes for patients, and the disproportionate impact on non-White patients is concerning. Further research is needed to identify the reasons for this delay and to mitigate its effects. Overall, the study highlights the need for ongoing vigilance to ensure that health care policies and interventions do not inadvertently worsen health disparities.

Global Smile Foundation's Cleft Surgical Outreach Program: Clinical and Economic Impact During the Past 14 Years.

Clefts of the lip and/or palate can result in significant morbidity as well as economic and psychosocial distress for patients and families. Global Smile Foundation is a non-profit organization committed to providing comprehensive cleft care to patients with cleft of the lip/palate around the world. Primary cleft lip and primary cleft palate repairs performed by the Global Smile Foundation in the last decade were reviewed. Averted disability-adjusted life years were estimated and assessed for their economic value. A total of 15,310 disability-adjusted life years were averted. The financial gain was estimated between $78,323,624 and $152,906,604, with an average financial benefit of $48,021 to $93,750 per patient.

Closure of maxillary lateral incisor agenesis space in unilateral cleft lip and palate: a digital model assessment.

OBJECTIVE: To compare dental positional and gingival parameters of maxillary anterior teeth in unilateral cleft lip and palate (UCLP) after orthodontic treatment with canine substitution due to lateral incisor agenesis. METHODS: This split-mouth study comprised 57 subjects with UCLP (31 male, 26 female) and agenesis of maxillary lateral incisor at the cleft side, from a single center. Canine substitution was completed after the secondary alveolar bone graft. Dental models were taken between 2 to 6 months after debonding (mean age: 20.4 years). The following variables were measured in the maxillary anterior teeth: crown height, width, proportion, and symmetry, as well as steps between incisal edges, gingival margins, tooth mesiodistal angulation and labiolingual inclination. Paired t-tests with Bonferroni post-hoc correction was used for comparisons between cleft and non-cleft sides (p<0.05). RESULTS: At the cleft side, canines replacing missing lateral incisors had a higher crown height (0.77mm) and an increased width (0.67mm), and first premolars showed a shorter crown height (1.39mm). Asymmetries were observed in the gingival level of central and lateral incisors, with a greater clinical crown at the cleft side (0.61 and 0.81mm, respectively). Cleft side central incisors were more upright than their contralaterals (2.12º). CONCLUSIONS: Maxillary anterior teeth demonstrated positional, size and gingival height differences between cleft and non-cleft side after space closure of maxillary lateral incisor agenesis. Slight asymmetries in tooth position and gingival margin in the maxillary anterior teeth should be expected after orthodontic treatment in UCLP patients.

Speech assessment following microsurgical soft palate repair.

The aim of this study was to analyze speech intelligibility of children, who had undergone microsurgical soft palate repair according to Sommerlad. Cleft palate patients were treated by closure of the soft palate according to Sommerlad at about 6 months of age. At the age of 11, their speech was evaluated through automatic speech recognition. Word recognition rate (WR) was used as the outcome parameter of automatic speech recognition. To validate automatic speech results, an institute for speech therapy evaluated the speech samples for perceptual intelligibility. The results of this study group were compared to an age-matched control group. A total of 61 children were evaluated in this study, 29 in the study group and 32 in the control group. Study group patients had a lower word recognition rate (mean 43.03, SD 12.31) compared to the control group (mean 49.98, SD 12.54, p = 0.033). The magnitude of the difference was considered small (95% CI of the difference 0.6-13.3). The study group patients received significantly lower scores in the perceptual evaluation (mean 1.82, SD 0.58) compared to the control group mean (mean 1.51, SD 0.48, p = 0.028). Again, the magnitude of the difference was small (95% CI of the difference 0.03-0.57). Within the limitations of the study it seems that microsurgical soft palate repair according to Sommerlad at the age of 6 months might be a relevant alternative to other well established surgical techniques.

Third-party Compliance With State-Mandated Orthodontic Coverage for Cleft Palate and Craniofacial Care in California: An Insurance Claim Thematic Analysis.

BACKGROUND: California Senate Bill 630 (SB630) enacted statutorily mandated health plan coverage for orthodontic care of patients with cleft palate and craniofacial anomalies in 2009, which was effective from July 1, 2010. In this qualitative analysis, third-party compliance with SB630 in a university-based cleft and craniofacial orthodontic program is evaluated. METHODS: Privately insured patients that experienced a coverage delay or denial of orthodontic treatment for cleft lip and palate in the University of California, San Francisco Cleft and Craniofacial Orthodontic Program between July 1, 2010 and October 28, 2020 were identified. A thematic analysis of reasons for delay or denial was conducted. RESULTS: Nearly three quarters of patients experienced coverage delay and/or denials. The most common reason given was that services were not covered. CONCLUSIONS: Despite state-mandated coverage, inappropriate denials of orthodontic care for patients with cleft lip and palate by private insurers persist in California.

A CBCT Based Assessment of Canine Eruption and Development Following Alveolar Bone Grafting in Patients Born With Unilateral Cleft lip and/or Palate.

To three-dimensionally assess and visualize the eruption path and development of the maxillary canine following alveolar bone grafting in patients born with cleft lip and palate. A further objective of this analysis was to assess how the presence of the lateral incisor impacts the eruption path of the canine.Observational follow-up study.Stockholm Craniofacial Team, Karolinska University Hospital, Sweden.Thirty children born with non-syndromic unilateral cleft lip with or without palate were consecutively included.CBCT scans of the maxilla were taken six months before and six months after the alveolar bone-grafting surgery for each patient.Canine eruption (angulation and vertical movement) and canine development (length and volume).There was a significant difference pre- and post-operatively of the canine angulation between the cleft and non-cleft sides. The mean angulation on the cleft side was 14.7° (SD = 11.1°) while on the non-cleft side, it was 4.9° (SD = 9.2°). No significant differences were noted between cleft-side and non-cleft side canines in terms of amount of vertical eruption and volumetric development. Absence of the lateral incisor did not significantly contribute to either canine angulation or its vertical eruption on the cleft-side.Higher angulation of the canine on the cleft side indicates a higher risk of future canine impaction. Presence or absence of the lateral incisor did not significantly affect canine angulation or its vertical eruption. Increased age and children born with total cleft lip and palate imply a higher risk of angulated canines on the cleft side.

Three-dimensional Assessment of Autologous Calvarial Bone Grafting for Alveolar Clefts Reconstruction in Pediatric Population: A Retrospective Study.

Reconstruction of alveolar clefts using cancellous bone graft is associated with a high rate of resorption. The aim of this study was to evaluate the osseointegration capacity of cortical calvarial bone grafting using 3-dimensional imaging assessment for alveolar cleft reconstruction in pediatric population.All alveolar bone grafting procedures performed between January 2015 and October 2017 in the maxillofacial surgery department of Lille University Hospital were included. All patients were evaluated clinically and by 3-dimensional imaging before bone grafting and at 3 months after surgery. Cleft and bone graft volumes were assessed using Horos software, v. 3.3.5, through a segmentation process. The bone filled ratio at 3 months after surgery was calculated. A total of 48 alveolar bone grafting procedures were performed in 37 patients: 3 unilateral cleft lip and alveolar, 20 unilateral cleft lip and palate, and 25 bilateral full cleft lip and palate (3 patients had only unilateral surgery). The mean bone filled ratio was 72.27%±23.65%, 81% for unilateral cleft lip and alveolus, 75.4%±20.6 for unilateral cleft lip and palate, and 65.5%±30 for bilateral complete cleft lip and palate ( P =0.1981). Calvarial bone grafting seems to be a relevant alternative to other donor sites for alveolar cleft reconstruction.

The Impact of the Covid-19 Pandemic on Cleft Lip and Palate Service Delivery for New Families in the United Kingdom: Medical and Community Service Provider Perspectives.

OBJECTIVES: Professionals in the United Kingdom providing care to new families affected by cleft lip and/or palate (CL/P) had to adapt to ensure families' needs were met during a time of uncertainty due to Covid-19. The aims of this study were to explore the impacts of the pandemic on CL/P care provision for new families from the perspectives of professionals working in medical and community settings along with any personal impact on professionals and their reflections on the future of CL/P care. DESIGN: Semistructured interviews (n = 27) were completed about experiences from March 2020 to October 2020 with consultant cleft surgeons (n = 15), lead clinical nurse specialists (n = 8), and staff working at the Cleft Lip and Palate Association (n = 4). Transcripts were analyzed using inductive thematic analysis. RESULTS: Three themes were identified: (1) the impact of Covid-19 on the provision of cleft care in the United Kingdom, including working conditions, delays to treatment, and Covid-19 policies; (2) the impact of the pandemic on professionals' mental health, including personal distress and concerns about Covid-19 exposure; and (3) reflections on the future of CL/P care, whereby professionals expressed both hope and concern about the Covid-19 recovery effort. CONCLUSIONS: The ongoing Covid-19 pandemic has impacted CL/P service delivery for new families significantly, warranting recommendations for cohesive psychological support for families in addition to a safe and resourced recovery effort. Support for professionals is also suggested, following existing evidence-based models for providers' needs that address the difficulties of working throughout challenging times.

A Novel and Practical Protocol for Three-Dimensional Assessment of Alveolar Cleft Grafting Procedures.

OBJECTIVE: To evaluate the reproducibility and accuracy of a new, easy-to-use volumetric assessment of the alveolar cleft. DESIGN: Twelve cone-beam computed tomography (CBCT) datasets of patients with a unilateral cleft lip, alveolus, and palate were evaluated by two investigators. Residual alveolar cleft calcified volume one year after surgery was analyzed by using standardized landmarks to determine the borders of the cleft defect and semi-automatically segment the alveolar cleft defect. RESULTS: The Dice-coefficient between observers for the segmented preoperative alveolar cleft defect was 0.81. Average percentage of residual alveolar cleft calcified material was 66.7% one year postoperatively. CONCLUSIONS: This study demonstrates a reliable and practical semi-automatic three-dimensional volumetric assessment method for unilateral clefts using CBCT.