Cleft Care Research Articles

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.

Epidemiologic Trends of Cleft Lip and Palate in a Southern State: A 30-Year Follow-Up.

Children's of Mississippi at the University of Mississippi Medical Center serves as the state's only American Cleft Palate-Craniofacial Association-approved cleft team at the only pediatric hospital in the state. The goal of this study is to report geographic and demographic patterns of patients with orofacial cleft (OFC) treated at Children's of Mississippi, which are lacking. Patients with OFC treated at Children's of Mississippi from 2015 to 2020 were included. Demographic data were collected, including birth county and total live births from state data. Significant differences between incidence of OFC among public health regions of Mississippi were examined using analysis of variance (P < 0.05). Cases were compared with historical data from 1980 to 1989. There were 184 patients who presented with OFC, with a statewide incidence of 0.83 per 1000 live births among 222,819 live births in the state across 6 years. The incidence of OFC was 0.83/1000 for Whites and 0.82/1000 for non-Whites versus a historical rate of 1.36 and 0.54, respectively. Significantly fewer children in the northern region (0.25/1000) were born with OFC than in central (1.21; P < 0.001) and southern (0.86; P < 0.001) regions. Results from this study suggest changing regional patterns of OFC in Mississippi. Although rates increased among non-White infants, the overall incidence of OFC has decreased compared with historical data. The findings may reflect actual incidence patterns in the state or the proximity of certain regions to Children's of Mississippi. Further study may reveal regional differences in risk factors underlying OFC incidence, and/or issues with access to cleft care for different regions in the state.

Gingivoperiosteoplasty in Children with Cleft Lip and Palate: The Need for Alveolar Bone Grafting.

This study aimed to determine the efficacy of gingivoperiosteoplasty (GPP) in preventing alveolar bone grafting (ABG) among children with cleft lip and palate (CLP). Retrospective university hospital single center study. Children with CLP treated with GPP from 2000-2015 were included. Those under eight years of age, without definitive conclusions regarding need for ABG or with incomplete data were excluded. Included patients were analyzed for demographics, cleft type, age at GPP, associated cleft surgery, use of nasoalveolar molding (NAM), indication for ABG, operating surgeon and presence of residual alveolar fistula. T-tests and Fisher's exact tests were utilized for statistical analysis. The need for ABG. Of the 1682 children identified with CLP, 64 underwent GPP and met inclusion criteria. 78% of patients with CLP who underwent GPP were recommended for ABG. Those who received GPP at a younger age (P = .004) and at the time of initial cleft lip repair (P = .022) were less likely to be recommended for ABG. Patients with complete CLP were more likely to be recommended for ABG than patients with cleft lip and alveolus only (P = .015). The operating surgeon impacted the likelihood of ABG (P = .004). Patient gender, race, ethnicity, laterality, and NAM were not significantly associated with recommendation for ABG. GPP does not preclude the need for ABG. Therefore, the success of ABG after GPP and maxillary growth restriction should be analyzed further to determine if GPP is a worthwhile adjunct to ABG in cleft care.

Crowdsourcing the Impact of Illustration in Cleft Surgery Education.

This study aimed to (1) assess layperson preferences for how surgical information is presented; (2) evaluate how the format of visual information relates to layperson comfort with undergoing surgery, perceptions of surgeon character traits, and beliefs about artistic skill impacting plastic surgery practice; and (3) identify sociodemographic characteristics associated with these outcomes. A survey was developed in which one of five standardized sets of information depicting a unilateral cleft lip repair was presented as (1) text alone, (2) quick sketches, (3) simple drawings, (4) detailed illustrations, or (5) photographs. Online crowdsourcing platform. Raters aged 18 years and older from the United States. None. After viewing the surgical information, participants answered three sets of Likert scale questions. Ratings were averaged to produce three composite scores assessing (1) comfort with undergoing surgery (2) perceptions of surgeon character traits, and (3) beliefs about plastic surgery and artistry. Four hundred seventy-nine participants were included. Surgeon character traits score was highest among participants who viewed detailed illustrations at 4.46 ± 0.59, followed by photographs at 4.43 ± 0.54, text alone at 4.28 ± 0.59, simple drawings at 4.17 ± 0.67, and quick sketches at 4.17 ± 0.71 (p = 0.0014). Participants who viewed detailed illustrations rated surgical comfort score and plastic surgery and artistry score highest, although differences did not achieve statistical significance. Viewing detailed cleft lip repair illustrations was significantly associated with positive perceptions of surgeon character traits. Our data help to contextualize methods of communication and education valued by the public when seeking cleft care.

Evaluating the Impact of a Global Cleft Speech Mentorship Program on Expanding Practitioner Competency in Low- and Middle-Income Countries.

A primary challenge in global cleft care lies in the limited opportunities for cleft-specific training and mentorship available to speech practitioners worldwide, particularly in low-income and middle-income countries (LMICs). In addition, the limited number of speech therapists with cleft experience in LMICs creates a significant barrier to access to care for individuals with cleft lip and palate globally. The inaccessibility of cleft-specific clinical instruction and cleft-trained speech therapists impacts the effectiveness of intervention and, subsequently, the speech-language development of cleft-affected individuals worldwide. A structured virtual clinical mentorship program targeting speech practitioners of all skill levels in LMICs was established to address this gap in comprehensive cleft care provision. This article will examine the effectiveness of a structured cleft speech mentorship program in expanding practitioner competency in LMIC communities and, as a result, building capacity for cleft speech care globally. The authors will outline various aspects of the development and implementation of this cleft speech mentorship program, including rationale, participant recruitment, program requirements, and impact assessment tools utilized. An analysis of pre-program and post-program data will be conducted to evaluate the degree to which clinical skills were improved, identify persistent areas of weakness, and examine the effectiveness of the program in expanding speech practitioner competency.

Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial.

The Timing of Primary Surgery (TOPS) trial was published August 2023 in the New England Journal of Medicine and is a milestone achievement for a study focused on cleft palate. Due to the complexity of outcome reporting in cleft and the rarity of such comparative trials, TOPS presents a useful opportunity to critically review the design, analysis and reporting strategies utilised. This perspective article focused on the inclusion of participants, the choice of the primary outcome measure and the analysis of ordinal data within the trial. Considerations for future comparative studies in cleft care are discussed.

Incomes to Outcomes: A Global Assessment of Disparities in Cleft and Craniofacial Treatment.

Recent investigations focused on health equity have enumerated widespread disparities in cleft and craniofacial care. This review introduces a structured framework to aggregate findings and direct future research. Systematic review was performed to identify studies assessing health disparities based on race/ethnicity, payor type, income, geography, and education in cleft and craniofacial surgery in high-income countries (HICs) and low/middle-income countries (LMICs). Case reports and systematic reviews were excluded. Meta-analysis was conducted using fixed-effect models for disparities described in three or more studies. N/A. Patients with cleft lip/palate, craniosynostosis, craniofacial syndromes, and craniofacial trauma. N/A. One hundred forty-seven articles were included (80% cleft, 20% craniofacial; 48% HIC-based). Studies in HICs predominantly described disparities (77%,) and in LMICs focused on reducing disparities (42%). Level II-IV evidence replicated delays in cleft repair, alveolar bone grafting, and cranial vault remodeling for non-White and publicly insured patients in HICs (Grades A-B). Grade B-D evidence from LMICs suggested efficacy of community-based speech therapy and remote patient navigation programs. Meta-analysis demonstrated that Black patients underwent craniosynostosis surgery 2.8 months later than White patients (P < .001) and were less likely to undergo minimally-invasive surgery (OR 0.36, P = .002). Delays in cleft and craniofacial surgical treatment are consistently identified with high-level evidence among non-White and publicly-insured families in HICs. Multiple tactics to facilitate patient access and adapt multi-disciplinary case in austere settings are reported from LMICs. Future efforts including those sharing tactics among HICs and LMICs hold promise to help mitigate barriers to care.

Perspectives on the state of cleft lip and cleft palate patient care in Africa.

Patients with cleft lip -palate (CLP) experience morbidity and social stigma, particularly in low-income and middle-income countries (LMICs) such as those of sub-Saharan Africa (SSA). Delays in treatment secondary either to lack of awareness, skills, equipment and consumables; poor health infrastructure, limited resources or a combination of them, has led to SSA having the highest rates of death and second highest rates of disability-adjusted life years in patients with CLP globally. Here we review current perspectives on the state of comprehensive cleft lip and palate repair in Africa. To bridge gaps in government health services, nongovernmental organizations (NGOs) have emerged to provide care through short-term surgical interventions (STSIs). These groups can effect change through direct provision of care, whereas others strengthen internal system. However, sustainability is lacking as there continue to be barriers to achieving comprehensive and longitudinal cleft care in SSA, including a lack of awareness of CLP as a treatable condition, prohibitive costs, poor follow-up, and insufficient surgical infrastructure. With dedicated local champions, a comprehensive approach, and reliable partners, establishing sustainable CLP services is possible in countries with limited resources. The replacement of CLP 'missions' with locally initiated, internationally supported capacity building initiatives, integrated into local healthcare systems will prove sustainable in the long-term.

Telepractice Parent Training of Enhanced Milieu Teaching With Phonological Emphasis (EMT+PE) For Persian-Speaking Toddlers With Nonsyndromic Cleft Palate: Protocol for a Randomized Controlled Trial.

Children born with a cleft palate with or without a cleft lip (CP/L) are at increased risk for delayed language development and speech sound disorders. Enhanced Milieu Teaching with Phonological Emphasis (EMT+PE) is a recommended naturalistic intervention for toddlers with CP/L. The parents' role in providing naturalistic interventions is critical and they need training based on learning principles to implement these interventions. Telepractice is an appropriate method for training parents and children with various speech-related disorders. This study aims to determine and compare the effectiveness of telepractice and the parent-implemented EMT+PE intervention on language and speech measures in toddlers with CP/L with usual interventions and determine the effectiveness maintenance of the intervention. A randomized controlled trial (RCT) will assess the efficacy of telepractice and the parent-implemented EMT+PE intervention in enhancing speech and language measures in toddlers with CP/L. Eligible participants will be randomly assigned to one of 2 groups: the conventional intervention group and the EMT+PE intervention group. Participants' speech and language measures will be evaluated remotely by trained raters before and after the intervention and 2 months after the intervention. Parents of participants in the intervention group will receive 3 months of training in speech and language supportive strategies from trained therapists using telehealth fidelity scales. Parents of participants in the control group will receive the conventional speech and language intervention by cleft team therapists. Study outcomes will include language variables (mean length of utterance) and speech production variables (percent correct consonants). The protocol was approved by the Research Ethics Committee of the University of Social Welfare and Rehabilitation Sciences in February 2022. The selection process of participants, as well as training therapists and raters, commenced in January 2022, the therapy and follow-up period ended in June 2023, and pre- and postintervention assessments have been conducted. Data analysis is ongoing, and we expect to publish our results by the summer of 2024. Funding is yet to be received. The results of this study may help us develop a speech and language intervention with a different delivery model for toddlers with CP/L, and the cleft team care can use these results in service delivery. Consistent with our hypothesis, speech and language measures are expected to improve. DERR1-10.2196/54426.

Cleft Summit 2022: The Impact of a Unified Voice

Objective The inaugural Cleft Summit aimed to unite experts and foster interdisciplinary collaboration, seeking a collective understanding of velopharyngeal insufficiency (VPI) management. Design An interactive debate and conversation between a multidisciplinary cleft care team on VPI management Setting A two-hour discussion within a four-day comprehensive cleft care workshop (CCCW). Participants Thirty-two global leaders from various cleft disciplines Interventions Cleft Summit that allows for meaningful interdisciplinary collaboration and knowledge exchange. Main Outcome Measures Ability to reach consensus on a unified statement for VPI management. Results Participants agreed that a patient with significant VPI and a dynamic velum should first receive a surgery that lengthens the velum to optimize patient outcome. A global, multicenter prospective study should be done to test this hypothesis. Conclusion The 1st Cleft Summit successfully distilled global expertise into actionable best-practice guidelines through iterative discussions, fostering interdisciplinary collaboration and paving the way for a transformative multi-center prospective study on VPI care.

Timing of Alveolar Bone Graft and Barriers to Care.

The current standard timing for alveolar bone grafting (ABG) occurs during mixed dentition, typically between the ages of six and twelve. A delay in receiving this operation is associated with an increase in graft loss and an overall thinner maxilla. This study aims to determine whether socioeconomic barriers are associated with a delay in timely ABG. A retrospective analysis of patients who received ABG at our institution since 2012. Patient demographics, cleft classifications, operative details, and surgical dates were examined. A logistic regression model was created using socioeconomic variables to predict patients receiving delayed ABG. Significant variables were then included in a backwards selection logistic regression, followed by a final analysis of maximum likelihood estimates. Single-institution, primary cleft care center. 202 patients with cleft palates who underwent ABG. ABG. Timing in which patients received ABG: standard (6-12 years) and delayed (>12 years). Female sex was a protective factor in the timing of ABG in our initial univariate analysis (OR = 0.44; p = .015). Socioeconomic factors resulting in delayed presentation for ABG include median income (OR = 1.0; p = .018) and public insurance status (OR = 3.75; p < .001). Median income, sex, and driving distance to the cleft clinic were not significant following backward elimination, however, private insurance status remained significant (OR = 3.71; p = .0001). Patients with public insurance are approximately 3.75 times more likely to receive ABG during permanent dentition. Multidisciplinary teams should work closely with patients on public insurance to ensure timely delivery of ABG.Level of Evidence III, Retrospective.

First Nations Patients’ Experience Receiving Care for Cleft Lip and Palate in a Multidisciplinary Clinic Setting

Purpose: Our small-scale qualitative study sought to explore the experiences of Indigenous patients receiving care for cleft lip and/or palate at a multidisciplinary clinic. There currently are no published studies that demonstrate the experiences of cleft lip and/or palate patients receiving care in multidisciplinary clinics in Canada. This work is foundational to informing future care in a way that is reflective and cognizant of Indigenous ways of life and lived experiences. Method: Participants were recruited via purposive and snowball sampling through community networks and public advertising in relevant healthcare spaces. Semi-structured interviews were completed; transcribed verbatim and descriptive codes were generated using Indigenist research methodologies through the Blackfoot medicine wheel. Results: Five participants that included patients, parents of patients with cleft lip and/or palate, and Indigenous health liasions were interviewed. Participants indicated a lack of spiritual health, the physical demands of having a cleft lip and/or palate on a patient and their families, the fear and unknown associated with a new cleft lip and/or palate diagnosis, and lack of cultural support, awareness and racism may negatively impact mental health. Conclusion: Indigenous patients must receive cleft lip and/or palate care that is cognizant of both their cultural needs identified in our study but also reflective of the ways in which health may be conceptualized for Indigenous patients. The following models of care suggested in our study must also seek to address historic mandates that include UNDRIP and the Truth and Reconciliation Commission's Calls to Action.

Barriers in Cleft Service Access in Sub-Saharan Africa: A Thematic Analysis of Practical Needs of Rural Families.

To explore the experiences and perceptions of barriers of parents and family members of patients with cleft lip and palate in accessing cleft services in remote northwest Nigeria. Face-to-face semi-structured audio recorded interviews were used to obtained qualitative textual data. Thematic analysis using interpretative descriptive techniques was employed to understand the participants' lived experiences with barriers and accessibility to cleft services. Participants were from Sokoto, Kebbi and Zamfara states in remote northwest, Nigeria. Consisted of 22 caregivers (17 parents and 5 extended family members) were purposively sampled between 2017 and 2020. Barriers experienced while accessing cleft services were identified during thematic analysis. Over three quarter of the respondents had patients with both cleft lip and palate and without any previous family history (n = 20). About two-thirds of the participants (n = 15) were females. Most of the interviews were conducted before the surgeries (n = 15). lack of information, financial difficulty, misrepresentation from health workers, multiple transportation and previous disappointment. Areas of poor awareness, misinformation from primary health care workers, financial hurdles, multiple transportation logistics and others were identified. Aggressive broadcasting of information through radio, timely treatment and collaboration with influential religious leaders were emphasized. Support, grants and subsidies from government and voluntary agencies are encouraged to mitigate the huge out of pocket cost of cleft care in the region.

Outcomes of primary repair of cleft palate using sommerled intravelar veloplasty associated with velocardiofacial syndrome

ObjectivesVelocardiofacial syndrome, a prevalent microdeletion syndrome occurring in 1 in 2000–4000 live births, is marked by speech and language disorders, notably velopharyngeal dysfunction. This study investigates speech outcomes, nasometric and videofluoroscopic results before and after primary repair of cleft palate using the Sommerlad intravelar veloplasty (SIVV) technique within the Isfahan cleft care team for patients with velocardiofacial syndrome. MethodsEmploying a quasi-experimental design, 19 participants with velocardiofacial syndrome, who underwent primary cleft palate repair by the Isfahan cleft care team, were included through convenience sampling. Perceptual and instrumental outcomes were assessed pre-and post-operatively. Statistical analysis encompassed paired t-tests and the non-parametric Wilcoxon signed-rank test (p < 0.05). ResultsThe study identified no statistically significant differences between pre-and post-surgical speech outcome parameters and nasalance scores. Nonetheless, a significant distinction emerged in the velopharyngeal closure ratio based on fluoroscopic evaluation (p = 0.038). ConclusionThe efficacy of the SIVV technique in treating velopharyngeal dysfunction in velocardiofacial syndrome patients is inconclusive, demanding further research. Post-surgical speech outcomes are influenced by surgical technique, hypotonia, apraxia of speech, and surgery timing. Notably, an elevated velopharyngeal valve closure ratio, though anatomically indicative, does not exclusively predict surgical success.

'Suspension Palatoplasty' - A method of surgical correction of VPI post Cleft Palate repair.

To design the technique of 'Suspension Palatoplasty' for Velopharyngeal Insufficiency (VPI) post Cleft Palate (CP) based on optimal spatial positioning of palate at the time of VPI correction, by using a non-obstructive, high, midline pharyngeal flap for predictable velopharyngeal closure and normal speech. To evaluate the results of CP patients with VPI operated using the technique of 'Suspension palatoplasty'. An ambi-spective longitudinal clinical study. Comprehensive cleft care clinic in a private trust hospital. Patients operated using the 'Suspension Palatoplasty' technique for VPI post CP repair between 2014 and 2018 with a minimum follow-up period of 5 years. 'Suspension Palatoplasty' - Double Opposing Z (DOZ) plasty with palatal myoplasty is used to revise soft palate and a narrow superiorly based pharyngeal flap is used to suspend it for a dynamic velopharyngeal closure. Speech outcome and surgical complications. 70 out of 119 studied were found to have normal speech (59%), and another 25 patients (21%) had acceptable speech. Thus 95 out of 119 patients (80%) had normal or near-normal speech and did not require any further speech therapy or surgeries. 12 patients had snoring without difficulty in breathing. One patient had symptoms suggestive of obstructive sleep apnea. Younger patients had a higher percentage of normal speech outcomes. Many of our adult patients also attained normal speech. 'Suspension Palatoplasty' aims to achieve normal speech with little effort. It has minimal side effects. The author has performed 403 cases to date.

Are NHS cleft services in England ready for delegation to integrated care systems?

Cleft care services in the UK have been nationally funded since centralisation 25 years ago and during this time have been able to demonstrate improved clinical outcomes. Integrated care systems have been introduced into legislature as part of the Health Care Act of 2022 and will be responsible for the paradigm shift of allocating funds on a regional basis for cleft care services in England from 2024. The proposed population-based funding formulas present an opportunity to improve current inequities in cleft care, including access to speech therapy and adult services. However, the regional footprint of integrated care systems does not align with that of the centralised cleft service system and represents a threat to the standardised patient-centred care that has taken two decades to build. Awareness needs to be raised so that cleft care providers can proactively adapt to this mandatory change to service funding to ensure that clinical standards are maintained and continue to improve.

Utilising massive open online courses to enhance global learning dissemination in cleft lip and palate: a case report of penta helix collaboration

BackgroundEducating and raising awareness in cleft lip and palate future generations is one vital effort to ensure the improvement of cleft care and research in the future. This study reported the overview in organising and evaluating the Massive Open Online Course (MOOC) in Cleft Lip and Palate as the alternative way for students’ capacity building outside their study program whilst also earning credits towards their studies.MethodsSmile Train cleft charity generously donated recorded lectures from cleft experts around the world in which each of the experts agreed to provide one-hour live discussion sessions. The learning activities ranging from lectures, pre- and post-course evaluation, forum, live discussion sessions, virtual visits to Indonesian Cleft Centre, self-reflection assignments and final project. A survey was released to the participants to collect their feedback.ResultsThe course mainly attracted dental students, and several allied health professional students. In total, 414 out of 717 participants registered for this MOOC managed to finish the course and received a certificate of completion which was run between August–October 2021. In general, participants positively received the course.ConclusionsThe MOOC model and its objective of disseminating widespread information across geographical boundaries to enhance learning about cleft lip and palate treatment was achieved. This report serves as an example for other educational institutions and stakeholders who plan to use online educational engagement platforms to provide high-quality education and capacity building to participants in lower-middle income countries.

Two-stage palatal repair in non-syndromic CLP patients using anterior to posterior closure is associated with minimal need for secondary palatal surgery

ObjectiveThe aim of the present study was to assess the need for secondary palatal corrective surgery in a concept of palate repair that uses a protocol of anterior to posterior closure of primary palate, hard palate and soft palate.MethodsA data base of patients primarily operated between 2001 and 2021 at the Craniofacial and Cleft Care Center of the University Goettingen was evaluated. Cleft lips had been repaired using Tennison Randall and Veau-Cronin procedures in conjunction with alveolar cleft repair. Cleft palate repair in CLP patients was accomplished in two steps with repair of primary palate and hard palate first using vomer flaps at the age of 10–12 months and subsequent soft palate closure using Veau/two-flap procedures 3 months later. Isolated cleft palate repair was performed in a one-stage operation using Veau/two-flap procedures. Data on age, sex, type of cleft, date and type of surgery, occurrence and location of oronasal fistulae, date and type of secondary surgery performed for correction of oronasal fistula (ONF)and / or Velophyaryngeal Insufficiency (VPI) were extracted. The rate of skeletal corrective surgery was registered as a proxy for surgery induced facial growth disturbance.ResultsIn the 195 patients with non-syndromic complete CLP evaluated, a total number of 446 operations had been performed for repair of alveolar cleft and cleft palate repair (Veau I through IV). In 1 patient (0,5%), an ONF occurred requiring secondary repair. Moreover, secondary surgery for correction of VPI was required in 1 patient (0,5%) resulting in an overall rate of 1% of secondary palatal surgery. Skeletal corrective surgery was indicated in 6 patients (19,3%) with complete CLP in the age group of 15 – 22 years (n = 31).ConclusionsThe presented data have shown that two-step sequential cleft palate closure of primary palate and hard palate first followed by soft palate closure has been associated with minimal rate of secondary corrective surgery for ONF and VPI at a relatively low need for surgical skeletal correction.

Analysis of Different Facets of the Rule of 10 for Cleft Lip Repair for Their Application in the Current Era.

To evaluate the relevance of the "rule of 10" as a deciding factor preoperatively for patients undergoing cleft lip repair in the Indian sub-continent. A questionnaire survey was conducted. All tertiary cleft care centers in the Indian subcontinent participated in an online questionnaire survey with anesthetic and surgical professionals. The primary goal of this survey was to determine the relevance and applicability of various aspects of the rule of 10 as a preoperative guideline for determining the timing of cleft lip repair in ASA I infants. The survey also aids in understanding the systemic factors that need to be prioritized and factors that are no longer of primary relevance indefining the timeline to undertake cleft lip repair in infants inthe current era. Surgeons and anesthetists from 31 tertiary cleft centers in India responded to the questionnaire. Specifically, 64.5% do not apply the "rule of 10" for deciding the timing of cleft lip repair, and 77% of the centers reported that cleft lip repair can be taken up in infants with hemoglobin levels in the range of 9-10 g/dL and an average weight of 4.5 kg. The average blood loss in unilateral lip repair ranged between 5 and 10 mL and 10 and 40 mL in children with bilateral lip repair. Three to six months was the average age at which cleft lip repair was undertaken at most of the centers in India. The rule of 10 is not considered a gold standard by most of the centers in India, and the decision-making was based on the overall physiological status of the patients, the experience of the surgeon, and the anesthetic and post-operative care facilities available at the center.

Early Results on the Efficacy of Demineralized Bone Matrix, Bone Morphogenic Protein, and Freeze-dried Bone Chips in Alveolar Cleft Repair.

Conventional treatment for alveolar cleft repair is done using autologous iliac crest alveolar bone graft (ABG). However, this method may not be ideal in all patients. Analysis of the efficacy of a mixture of demineralized bone matrix (DBX), bone morphogenic protein (rhBMP-2), and freeze-dried bone chips (FDBC) as an alternative for alveolar cleft repair was performed. Consecutive patients from August 2019 to June 2022 undergoing early alveolar cleft repair, concomitant hard palate and alveolar cleft repair, secondary alveolar cleft repair, and regrafting from a previously failed ABG were analyzed. Computed tomography scans were performed to evaluate graft take at least 6 months postoperatively. Images were reviewed and scored. Alveolar graft height and graft thickness were recorded. A standardized scoring system was developed, with a score of 0 representing no graft take and 3 representing best possible graft take. Fifty-five consecutive alveolar clefts (43 patients) were identified as having undergone ABG and satisfied all the other inclusion criteria. Of these, 29 underwent first time ABG and 26 underwent redo ABG. The mean graft height and graft thickness recorded for all clefts was 2.2 and 2.0, respectively. Early results evaluating the efficacy of ABG using DBX, rhBMP-2, and FDBC show feasibility in regard to both graft height and thickness when using a maxillary computed tomography scan to measure the bone graft take. These results suggest that DBX, rhBMP-2, and FDBC may act as a versatile bone graft material in cleft care, although further studies are needed to determine long-term outcomes.