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Bone Tissue Engineering Strategies for Alveolar Cleft: Review of Preclinical Results and Guidelines for Future Studies
Park, Jenn J; Rochlin, Danielle H; Parsaei, Yassmin; Shetye, Pradip R; Witek, Lukasz; Leucht, Philipp; Rabbani, Piul S; Flores, Roberto L
The current standard of care for an alveolar cleft defect is an autogenous bone graft, typically from the iliac crest. Given the limitations of alveolar bone graft surgery, such as limited supply, donor site morbidity, graft failure, and need for secondary surgery, there has been growing interest in regenerative medicine strategies to supplement and replace traditional alveolar bone grafts. Though there have been preliminary clinical studies investigating bone tissue engineering methods in human subjects, lack of consistent results as well as limitations in study design make it difficult to determine the efficacy of these interventions. As the field of bone tissue engineering is rapidly advancing, reconstructive surgeons should be aware of the preclinical studies informing these regenerative strategies. We review preclinical studies investigating bone tissue engineering strategies in large animal maxillary or mandibular defects and provide an overview of scaffolds, stem cells, and osteogenic agents applicable to tissue engineering of the alveolar cleft. An electronic search conducted in the PubMed database up to December 2021 resulted in 35 studies for inclusion in our review. Most studies showed increased bone growth with a tissue engineering construct compared to negative control. However, heterogeneity in the length of follow up, method of bone growth analysis, and inconsistent use of positive control groups make comparisons across studies difficult. Future studies should incorporate a pediatric study model specific to alveolar cleft with long-term follow up to fully characterize volumetric defect filling, cellular ingrowth, bone strength, tooth movement, and implant support.
PMID: 35678607
ISSN: 1545-1569
CID: 5248492
Implementation of an Ambulatory Cleft Lip Repair Protocol: Surgical Outcomes
Park, Jenn J; Colon, Ricardo Rodriguez; Chaya, Bachar F; Rochlin, Danielle H; Chibarro, Patricia D; Shetye, Pradip R; Staffenberg, David A; Flores, Roberto L
OBJECTIVES/OBJECTIVE:Cleft lip repair has traditionally been performed as an inpatient procedure. There has been an interest toward outpatient cleft lip repair to reduce healthcare costs and avoid unnecessary hospital stay. We report surgical outcomes following implementation of an ambulatory cleft lip repair protocol and hypothesize that an ambulatory repair results in comparable safety outcomes to inpatient repair. DESIGN/SETTING/METHODS:This is a single-institution, retrospective study. PATIENTS/PARTICIPANTS/METHODS:Patients undergoing primary unilateral (UCL) and bilateral (BCL) cleft lip repair from 2012 to 2021 with a minimum 30-day follow-up. A total of 226 patients with UCL and 58 patients with BCL were included. INTERVENTION/METHODS:Ambulatory surgery protocol in 2016. OUTCOME MEASURES/METHODS:Variables include demographics and surgical data including 30-day readmission, 30-day reoperation, and postoperative complications. RESULTS:There were no differences in rates of 30-day readmission, reoperation, wound complications, or postoperative complications between the pre- and post-protocol groups. Following ambulatory protocol implementation, 80% of the UCL group and 56% of the BCL group received ambulatory surgery. Average length of stay dropped from 24 h pre-protocol to 8 h post-protocol. The 20% of the UCL group and 44% of the BCL group chosen for overnight stay had a significantly higher proportion of congenital abnormalities and higher American Society of Anesthesiology (ASA) class. Reasons for overnight stay included cardiac/airway monitoring, prematurity, and monitoring of comorbidities. There were no differences in surgical outcomes between the ambulatory and overnight stay groups. CONCLUSIONS:An ambulatory cleft lip repair protocol can significantly reduce average length of stay without adversely affecting surgical outcomes.
PMID: 35469454
ISSN: 1545-1569
CID: 5205502
Craniofacial Distraction: Orthodontic Considerations
Avinoam, Shayna; Shetye, Pradip R
A combined surgical and orthodontic approach to midface and mandibular distraction optimizes stability and outcomes. Orthodontic considerations include proper planning of the distraction vector, appropriate device use, and thorough follow-up through the consolidation and postoperative period. The dental occlusion must be managed throughout treatment in order to achieve ideal results.
PMID: 34051904
ISSN: 1558-0504
CID: 5075012
Correction of Severe Facial Asymmetry in Patients With Unilateral Craniofacial Microsomia Using Computer-Aided Design/Computer-Aided Manufacturing Technology: An Evaluation of Postsurgical Results
Shetye, Pradip R; Grayson, Barry H; McCarthy, Joseph G
ABSTRACT/UNASSIGNED:This is a retrospective study to evaluate the postsurgical position of the maxilla and mandible in 5 matured craniofacial patients with unilateral craniofacial microsomia who underwent 2 jaw surgical procedures using computerized surgical planning. The craniofacial surgeon and orthodontist completed the virtual surgical treatment plan with a biomedical engineer's assistance via a web meeting. The treatment plan of each patient included 2 jaw surgery with genioplasty. At the maxillary dental midline, the planned mean advancement was 4 mm; yaw, a rotational correction towards the unaffected side was 4.96 mm; and impaction was 2.74 mm. The mean advancement measured at point B was 10.5 mm, and the rotational correction towards the unaffected side was 6.58 mm. The mean advancement following genioplasty was 8.43 mm, and the mean transverse correction was 6.33 mm towards the midsagittal plane. The intermediate surgical splint, final surgical splint, bone graft templates, and cutting guides were constructed utilizing computer-aided design/computer-aided manufacturing technology. The surgeon executed the treatment plan in the operating room using appropriate computer-generated guides and splints. A postsurgical cone-beam computed tomography scan was obtained and superimposed on the surgical treatment plan using Simplant OMS 10.1 software. The cranial base was used as a reference for superimposition. Three-dimensional color-coded displacement maps were generated to visually and quantitatively assess the surgical outcome. There was a mean error of 0.88 mm (+0.30) for the position of the maxillary anatomical structures from the planned position, and the anterior mandibular anatomical structures were on average 0.96 mm (+0.26) from the planned position.
PMID: 34260455
ISSN: 1536-3732
CID: 5038842
Longitudinal Skeletal Growth Analysis of Mandibular Asymmetry in Unoperated Patients With Unilateral Craniofacial Microsomia (UCFM)
Shetye, Pradip R; Grayson, Barry H; McCarthy, Joseph G
PURPOSE/OBJECTIVE:To examine the growth rate discrepancy of the affected and unaffected ramus heights in Pruzansky Type I and Type II mandibles. METHODS:This is a serial retrospective longitudinal growth study of 30 untreated patients (21 males and 9 females) with UCMF (age range from 5 years to 14 years). The mean age of patients was 8.5 years, and the mean follow-up records were 3.7 years. There were 13 patients in group I with a Pruzansky Type I mandible and 17 patients in group II with a Pruzansky Type II. The unaffected side of the mandible served as a control. Eighteen cephalometric parameters were examined at each of the two-time intervals. RESULTS:In patients with Pruzansky Type I mandible, the affected ramus grew on average 1.41 mm per year; the unaffected ramus grew 1.66 mm per year during the same period. In patients with Pruzansky Type II mandible, the affected ramus grew on average 0.84 mm per year; during the same period, unaffected ramus grew 1.79 per year. When the growth rate of the ramus height on the affected side was compared to the unaffected side, there was no statistically significant difference in Pruzansky Type I mandibles (p > .05); however, there was a statistically significant difference in the Pruzansky Type II mandibles (p < .05). CONCLUSION/CONCLUSIONS:The growth rate discrepancy of the affected and unaffected ramus heights was more severe in Pruzansky Type II mandibles than Pruzansky Type I mandibles explaining the progressive nature of facial asymmetry in Pruzansky II mandibles.
PMID: 34730031
ISSN: 1545-1569
CID: 5038142
One-Year Stability of LeFort I Advancement in Patients With Complete Cleft Lip and Palate Using a Standardized Clinical and Surgical Protocol
Parikh, Vrajkumar; Gonchar, Marina; Gibson, Travis L; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R
AIM/OBJECTIVE:To assess treatment outcome and 1-year stability of LeFort I advancement in patients with complete cleft lip and palate. METHODS:Thirty-five patients (age 20.65 ± 2.20 years) with unilateral (n = 25) or bilateral (n = 10) complete cleft lip and palate who underwent LeFort I advancement were included.Lateral cephalograms before surgery (T1), immediately postsurgery (T2), and at 1-year follow-up (T3) were superimposed, and the position of anterior nasal spine (ANS), A-point, and U1 Tip assessed using an x, y coordinate system. Differences between landmark positions at the 3-time points were analyzed using paired sample t-tests, with a significance defined as α ≤ 0.05. RESULTS:The mean surgical advancement in the horizontal direction (T2-T1) was 6.50 ± 2.62 mm at ANS (P < 0.001) and 7.05 ± 2.51 mm at A-point (P < 0.001). At a 1-year follow-up (T3-T2), the mean horizontal relapse at ANS was -1.41 ± 1.89 mm (P < 0.001) and -0.79 ± 1.48 mm at A-point (P 0.003). Mean horizontal relapse was 21.7% and 11% of surgical advancement when assessed at ANS and A-point, respectively. The central incisor tip position remained stable during the postsurgical period (0.12 ± 2.11 mm, P 0.732). At A-point, the mean vertical surgical change (T2-T1) was -0.96 ± 2.57 mm (P < 0.001). No significant post-treatment (T3-T2) vertical changes were detected at ANS or A-point. Phenotypic stability was excellent, with all patients maintaining positive overjet at 1-year follow-up. CONCLUSIONS:LeFort I advancement in complete cleft lip and palate is stable, with less than a 2 mm relapse after 1-year. Surgical overcorrection by 10% to 20% is recommended to compensate for the expected skeletal relapse.
PMID: 34260467
ISSN: 1536-3732
CID: 4938632
Prevalence of Dental Anomalies in Patients With Unilateral Cleft Lip and Alveolus Treated With Gingivoperiosteoplasty
Gibson, Travis L; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:To compare the prevalence of dental malformations and agenesis in patients who received or did not receive gingivoperiosteoplasty (GPP). DESIGN/UNASSIGNED:Retrospective cohort study. PATIENTS/UNASSIGNED:Review of patients born January 1, 2000, to December 31, 2007, with unilateral cleft lip and alveolus, with or without clefting of the secondary palate, who received GPP and/or secondary alveolar bone grafting (ABG). Patients were included if they had clinical images and dental radiographs available at ages 5 to 9 and 10 to 12 years. Ninety-four patients met the inclusion criteria; 46 treated with GPP, and 48 who did not receive GPP. OUTCOME MEASURES/UNASSIGNED:tests. RESULTS/UNASSIGNED:Cleft side lateral incisors were absent in 54% of GPP patients, compared to 50% in the no-GPP group. Two patients in the GPP group and 1 in the no-GPP group had supernumerary lateral incisors. Most lateral incisors were undersized or peg shaped in both the no-GPP (83.3%) and GPP (71.4%) groups. In the GPP group, 5 (10.9%) patients exhibited central incisor agenesis, and 3 had significant hypoplasia. In the no-GPP group, 4 (8.3%) patients exhibited central incisor agenesis, and 5 (10.5%) significant hypoplasia. These differences were not statistically significant. CONCLUSIONS/UNASSIGNED:Gingivoperiosteoplasty was not associated with increased prevalence of dental malformation or agenesis. When performed appropriately, GPP is a safe treatment technique that does not increase the risk of dental anomalies.
PMID: 34259074
ISSN: 1545-1569
CID: 4938562
Skeletal and Dental Stability Following Different Magnitude of Le Fort I Advancement in Patients With Cleft Lip and Palate
Wangsrimongkol, Buddhathida; Flores, Roberto L; Staffenberg, David A; Rodriguez, Eduardo D; Shetye, Pradip R
PURPOSE/OBJECTIVE:The purpose of this study was to measure the association between the magnitude of advancement and dental and skeletal relapse in patients with cleft lip and palate (CLP). METHODS:A single-institution retrospective cohort study of skeletally matured patients with CLP who underwent isolated Le Fort I advancement surgery between 2013 and 2019 was studied. Patients were included if they had lateral cephalograms or cone-beam computed tomography (CBCT) at preoperative (T1), immediately postoperative (T2), and 1-year follow-up (T3). Lateral cephalometric landmarks were digitized and measured. The sample was divided on the basis of the magnitude of skeletal advancement: minor (<5 mm), moderate (≥5 but <10 mm), and major (≥10 mm) advancement groups. The mean advancement and relapse were compared between groups using 1-way ANOVA. Correlation between the amount of surgical advancement and relapse was evaluated. RESULTS:Forty-nine patients with nonsyndromic CLP with hypoplastic maxilla met inclusion criteria and the sample consisted of 36 males and 13 females with the mean age of 19.5 years. In the minor, moderate, and major advancement groups, the mean advancement at point A was +4.1 ± 0.4, + 7.5 ± 1.4, and +11.3 ± 1.3 mm, respectively. At 1-year follow-up, the mean relapse at point A was -1.3 ± 1.2, -1.1 ± 1.2, and -1.7 ± 1.5 mm, respectively. There was no significant difference in the relapse amount between all surgical groups. No correlation between the magnitude of advancement and relapse was found. CONCLUSIONS:This study demonstrated no statistically significant difference in skeletal stability between a minor (<5 mm), moderate (≥5 but <10 mm), and major (≥10 mm) Le Fort I advancement groups in patients with clefts. Regardless of the degree of advancement, mild skeletal relapse was observed in all 3 groups.
PMID: 34153247
ISSN: 1531-5053
CID: 4918192
Simulation-based comprehensive cleft care workshops: A reproducible model for sustainable education [Meeting Abstract]
Melhem, A; Al, Abyad O; Chahine, E; Breugem, C; Keith, K; Kassam, S; Vijayakumar, C; Bow, M; Alfonso, A; Esenlik, E; Patel, K; Shetye, P; Santiago, P; Losee, J; Steinbacher, D; Kummer, A; Flores, R; Rossell-Perry, P; Garib, D; Alonso, N; Mann, R; Pamplona, M; Giugliano, C; Prada-Madrid, J R; Padwa, B; Raposo-Amaral, C -E; Sommerlad, B; Tse, R; Bennun, R; Collares, M; Kantar, R; Hamdan, U
Background/Purpose: Newborns with cleft lip and/or palate (CLP) exceed 100 000 per year in low- and middle-income countries (LMICs). Patients, if left untreated, are at high risk of morbidity, due to functional deficits, malnutrition, aspiration, and infections. Limited resources in LMICs create barriers for establishing Interdisciplinary Cleft Care programs. Surgical missions driven by nonprofit organizations have been able to partially address this need, but their ability to promote long-term sustainable cleft care has come to a question. Simulation-based training has emerged as an essential tool for enhancing medical education and training. Global Smile Foundation, a nonprofit organization, is a leader in the establishment of Interdisciplinary Cleft Care programs, with its volunteers being involved in cleft care for over 3 decades. We were able to demonstrate the efficacy of our first Simulation-Based Comprehensive Cleft Care Workshop (SBCCW), in the Middle East-North Africa (MENA) region, and its wide acceptance by our recipients. In the current study, we want to prove the effectiveness and successfulness of our second SBCCW, in Latin America. Methods/Description: Our second SBCCW took place in Lima, Peru, in October 2019. Hands-on simulations of CLP repair using highfidelity CLP simulators were also provided to our participants. Participants were asked to complete a satisfaction survey at the end. Attendees were also asked about the obstacles facing cleft care in their countries and the possible interventions to overcome these obstacles. Short-term (at the end of the SBCCW) and medium-term (6 months later) follow ups were conducted by our team collecting data about improvements in the participants' competence, performance, outcomes, clinical care, and whether the SBCCW has changed their practice. Procedural confidence for pre- and postsimulation was evaluated using the psychometrically validated tool for measuring selfconfidence during surgical learning. Descriptive statistics were used for the collected data. Data analyses were performed using the Statistical Package for the Social Sciences. XXResult(s): Ninety-eight of the 198 participants from 29 different countries filled the satisfaction survey at the end of the workshop. The 2 most common barriers to cleft care in LMICs identified by our participants are the absence of financial support and the absence of multidisciplinary teams. Respondents claimed an improvement in their procedural confidence after the simulation sessions. Respondents had consistent short-term and medium-term impressions about the SBCCW positively impacting their competence, performance, outcomes, clinical care, and even changing their practice. XXConclusion(s): This study provides evidence that implementation of a SBCCW leads to a significantly improved procedural confidence, as well as a sustained positive impact on the clinical practice of the participants, reinforcing its role as a cleft care capacity-building tool
EMBASE:635187570
ISSN: 1545-1569
CID: 4911892
Three-Dimensional Nasolabial Changes After Nasoalveolar Molding and Primary Lip/Nose Surgery in Infants With Bilateral Cleft Lip and Palate
Mancini, Laura; Avinoam, Shayna; Grayson, Barry H; Flores, Roberto L; Staffenberg, David A; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:Utilize 3-dimensional (3D) photography to evaluate the nasolabial changes in infants with bilateral cleft lip and palate (BCLP) who underwent nasoalveolar molding (NAM) and primary reconstructive surgery. DESIGN/UNASSIGNED:coordinates to obtain the linear and angular measurements. Nasal form changes were measured and analyzed between T1 (0.5 months old), T2 (5 months old), and T3 (6 months old). Intraclass correlation coefficient was performed for intrarater reliability. Averaged data from the 3D images was statistically analyzed from T1 to T2 and T2 to T3 with Wilcoxon tests. Unaffected infant norms from the Farkas publication were used as a control sample. RESULTS/UNASSIGNED:After NAM therapy, statistically significant changes in the position of subnasale and labius superius improved nasolabial symmetry. Both retruded after NAM were displaced downward after NAM and surgical correction with respect to soft tissue nasion. The nasal tip's projection was maintained with NAM and surgical correction. The columella lengthened from 1.4 to 4.71 mm following NAM. CONCLUSIONS/UNASSIGNED:There was a significant improvement in the nasolabial anatomy after NAM, and this was further enhanced after primary reconstructive surgery.
PMID: 34032145
ISSN: 1545-1569
CID: 4887702