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Midface Growth in Patients With Unilateral Cleft Lip and Palate Treated With a Nasoalveolar Molding Protocol

Rubin, Marcie S; Clouston, Sean A P; Esenlik, Elçin; Shetye, Pradip R; Flores, Roberto L; Grayson, Barry H
This retrospective cohort study aimed to determine the impact of a nasoalveolar molding (NAM) protocol on midface growth in school-aged children with non-syndromic unilateral cleft lip and palate (UCLP). Data from 56 consecutively treated, NAM-prepared, Caucasian patients with non-syndromic UCLP from a single US cleft palate center were compared to pooled center data based on 56 patients with non-syndromic UCLP treated at 2 Eurocleft centers that did not use presurgical infant orthopedics (non-PSIO). Lateral cephalograms were obtained and 28 landmarks were identified. Published cephalometric measurements from Eurocleft centers were used for comparison. Seven cephalometric measurements (SNA, SNB, ANB, A'N'B', G'-Sn'-Pg', Sn-CT-LS, ANS-Me/N-Me%), available or derivable for both centers, were analyzed. Means and standard deviations for the 7 measurements were calculated for the NAM center. Student's t-tests were used to compare group means for 6 of the measures and a test of proportion was used for ANS-Me/N-Me%. No significant differences were found between the NAM protocol-prepared group and the Eurocleft non-PSIO centers on any of the 7 analyzed cephalometric relationships after accounting for false discovery rate. The NAM treatment protocol does not appear to impact skeletal or soft tissue facial growth in school-aged children with non-syndromic UCLP.
PMID: 30950956
ISSN: 1536-3732
CID: 3826272

Nasolabial Aesthetics Following Cleft Repair: An Objective Evaluation of Subjective Assessment

Kantar, Rami S; Maliha, Samantha G; Alfonso, Allyson R; Wang, Maxime M; Ramly, Elie P; Eisemann, Bradley S; Shetye, Pradip R; Grayson, Barry H; Flores, Roberto L
OBJECTIVE/UNASSIGNED:Assess the weight and contribution of each of the parameters of the Asher-McDade Scale to overall subjective assessment of nasolabial aesthetics following cleft lip repair. DESIGN/UNASSIGNED:Retrospective cohort evaluation. SETTING/UNASSIGNED:Cleft and craniofacial center. PARTICIPANTS/UNASSIGNED:Forty-one patients who underwent unilateral cleft lip repair. INTERVENTIONS/UNASSIGNED:Unilateral cleft lip repair. MAIN OUTCOME MEASURES/UNASSIGNED:Nasolabial rating using the Asher-McDade scale and overall subjective assessment of nasolabial aesthetics using a rank score following unilateral cleft lip repair. RESULTS/UNASSIGNED:= .69; P < .001). CONCLUSION/UNASSIGNED:The parameters evaluated in the Asher-McDade scale have different weights and contribute differently to overall subjective assessment of nasolabial aesthetic outcomes following cleft lip repair. Adjusting for their weights results in a modified score that demonstrates superior correlation with overall subjective assessment of nasolabial aesthetic outcomes.
PMID: 31117813
ISSN: 1545-1569
CID: 4055152

Developing an oral hygiene instruction (OHI) protocol to parallel the surgical postoperative care after cleft lip/palate surgery [Meeting Abstract]

Kassam, S; Almas, F; Kreps, B; Ahmed, M; Kantar, R; Ramly, E; Hughes, C; Herman, L; Grayson, B; Hamdan, U
Background/Purpose: To develop guidelines for oral hygiene procedures following cleft lip/palate (CL/P) surgery. To share post surgical oral hygiene protocols with other organizations/institutions to stimulate dialogue between their Surgical and Dental Teams. Methods/Description: Global Smile Foundation (GSF), a registered nonprofit organization, whose volunteers have over 3 decades of follow-up care, would like to develop a parallel OHI protocol after each stage of CL/P surgery. GSF has explored the use of various combined OHI methods (including toothbrush, sponge, chlorhexidine, and CPC). GSF's surgical and dental team are developing their own OHI protocol(s) specific to the age of patient and type of surgery, including: (a) type of instrument (toothbrush, sponge on a stick) to use initially postsurgery, (b) timing to restart toothbrushing postsurgery, (c) type of toothpaste (fluoridated or not-fluoridated) to use initially postsurgery, (d) use of mouth rinse postoperatively, such as chlorhexidine (alcohol or alcohol-free) or cetylpyridinium chloride (CPC), (e) location/surfaces of tooth brushing and which surgical sites to avoid, (f) liquid or soft food diet recommendations, and (g) timing of when normal routine should be resumed. A literature review was conducted of surgical and nonsurgical methods, along with a review of the existing OHI protocols from 30 registered US cleft centers, and guidelines of various national and international organizations/institutions (ACPA, ICHOM, CLEFTSIS, etc).
Result(s): Literature search revealed that most cleft care organizations have a set of protocols for postoperative care of the wound site after surgery. However, a specific OHI protocol wasn't found. Rinsing with water, traditional protocols and what NOT to do (pacifier, bottle, thumb, etc) was the extent of the information found. There is a wide range of post surgical protocols among clinicians and different centers. Despite these contradictory approaches (liquid diet vs soft food, brushing vs rinse only, chlorhexidine vs no rinsing), there seems to be no difference in outcome of surgery and long-term oral health. Nonetheless, this is an area that has not been formerly studied.
Conclusion(s): The goal of postsurgical OHI protocol should be to reduce the burden of bacterial load /bio film and to keep the wound site as healthy as possible, allowing for optimal healing. The post surgical OHI protocol should be mutually supported by both the surgical and dental teams. However, does the specific OHI protocol affect the surgical outcome? Further testing to measure the markers of post surgical oral hygiene and its impact on the outcome of surgery is needed
EMBASE:629085401
ISSN: 1545-1569
CID: 4071002

Learner satisfaction with 3-dimensional affordable stone models for cleft lip markings: Results from a prospective study [Meeting Abstract]

Kantar, R; Gonchar, M; Maliha, S; Ramly, E; Alfonso, A; Eisemann, B; Shetye, P; Grayson, B; Saadeh, P; Flores, R
Background/Purpose: Knowledge of cleft lip (CL) surgical markings is essential prior to performing the repair. Work hours restrictions, increased patient care documentation time, and requests by patients not to have trainees involved in their care are limiting the acquisition of this skill in the operating room. Textbooks provide 2-dimensional illustrations of CL markings; while the cost of 3-dimensional (3D) printed CL models prohibit their widespread utilization for this purpose. We propose 3D stone models as simple and affordable tools to teach surgical trainees unilateral CL markings. Methods/Description: Polyvinyl siloxane (PVS) impression material was used to create a negative of a patient with unilateral CL. Snapstone mixed with water was poured into the PVS impression to create unilateral CL stone models. Eleven plastic surgery residents were prospectively recruited in the study. They were provided with a textbook chapter and online module detailing surgical markings for unilateral CL repair, and were given 15 minutes of study time, before providing them with a unilateral CL stone model for performing the CL markings within 10 minutes. The participants were then provided with a standardized patient photograph for the same purpose. Learner satisfaction with the stone model and patient photograph as educational tools for learning surgical markings were evaluated using a modified survey based on the Student Evaluation of Educational Quality (SEEQ) survey, a validated tool for measuring higher education student satisfaction. Learner satisfactions with each tool were compared using a Mann-Whitney U test.
Result(s): The total production time of one stone model, including the PVS impression, was 10 minutes. The cost of one PVS impression and one stone model were 64 and 83 cents respectively, for a total of $1.47. Participants reported that when compared to the standardized patient photograph, the stone model was more stimulating (4.72 +/- 0.47 vs 3.82+/-0.87; U = 25.5; P = .01), increased their interest in the subject (4.63 +/- 0.50 vs 3.45 +/- 1.29; U = 26.5; P = .02), allowed better learning of the subject matter (4.54 +/- 0.52 vs 2.91 +/- 0.83; U = 5.0; P < .001), had greater clarity (4.64 +/- 0.50 vs 3.00 +/- 0.89; U = 6.0; P < .001), and was a more effective means of teaching CL markings (4.73 +/- 0.47 vs 2.91 +/- 1.04; U = 6.0; P < .001). Participants were also more likely to recommend the stone model (4.82+/-0.40) over the standardized patient photograph (3.00 +/- 1.10; U = 5.0; P < .001).
Conclusion(s): 3D stone models of the unilateral cleft lip deformity are affordable and simple to produce. Plastic surgery residents report that these models are superior training tools to learn cleft lip markings compared to patient photographs. These educational tools have the potential to overcome significant financial, logistic, and time constraints in teaching cleft lip surgery markings
EMBASE:629085954
ISSN: 1545-1569
CID: 4070972

Advancednam training as part of comprehensive cleft care in an outreach setting, creating a sustainable model: Seven years later [Meeting Abstract]

Kassam, S; Ahmed, M; Roman, L; Franco, D; Ayala, F; Grayson, B; Hamdan, U
Background/Purpose: Identify components needed to create a sustainable model. Methods/Description: Global Smile Foundation (GSF) is a not-forprofit foundation whose volunteers have been providing outreach cleft care in Guayaquil, Ecuador, for over 3 decades. Building on GSF's efforts to provide comprehensive and multidisciplinary cleft care yearround, an advanced training program in NasoAlveolar Molding (NAM) therapy was started in 2012 as part of GSF's empowerment and sustainability initiative. Components needed in host country were (1) establishing infrastructure, (2) cleft team (including cleft surgeon, speech pathologist, dental and psychosocial health-care professionals), (3) training of qualified local cleft health-care providers to ensure continued treatment and follow up, (4) academic collaboration: provide qualified trainers for NAM (didactic, clinical, laboratory), (5) local ownership and leadership, (6) local empowerment and sustainability programs, (7) yearly Follow-up.
Result(s): Year 1 (2012): 3 months training of 2 NAM providers (prosthodontist, orthodontist) prior to yearly surgical mission. Twenty patients treated w/NAM, NAM center continued year round, new patients followed by local cleft surgeon. Year 2 (2013): Existing providers train additional new provider (orthodontist) under supervision of visiting trainers. Fifty-seven patients treated w/NAM for the cleft team. Year 3 (2014): under same model, 2 new NAM providers trained (pediatric dentists). Year 4 (2015): Both providers remain at center, one becomes cleft team coordinator. Official cleft team established. Year 5 (2016): 2 international providers (pediatric dentist, orthodontist) selected for training to integrate NAM into their comprehensive cleft care model. NAM training expanded to cover educational components needed to set up comprehensive cleft team and NAM clinic in home settings. Training timed during surgical mission to rotate in all specialties and expanded to include online modules. Year 6 (2017): 2 new providers trained (periodontist, dentist) to remain at cleft center year round. Year 7 (2018): 3 International GSF providers (dentist, orthodontists) trained to provide NAM treatment at their centers. Total of 175 patients treated w/NAM. 2012-2018: Twelve dental providers trained in presurgical NAM and comprehensive cleft care in an outreach setting (7 from Ecuador, 2 from Peru, 1 from Salvador, 1 from Nicaragua, 1 from Egypt). 2012 Fundacion Global Smile-Ecuador was founded to ensure sustainability of ongoing and expanding cleft care programs. 2015 Comprehensive Cleft Center officially established at Leon Becerra Hospital in Guayaquil, Ecuador. In addition to their support of GSF's surgical missions, the local governorship started funding a presurgical NAM position to deliver presurgical and dental care year-round. By 2018, 175 patients had received NAM therapy.
Conclusion(s): Over the 7 years, our experience has shown, in addition to academic training and follow-up, local empowerment is key for long-term sustainability of the model
EMBASE:629086018
ISSN: 1545-1569
CID: 4070952

Cleft lip and palate: Development of a dental database in an outreach setting [Meeting Abstract]

Kassam, S; Kreps, B; Almas, F; Kantar, R; Ramly, E; Hughes, C; Grayson, B; Hamdan, U
Background/Purpose: To develop a database that documents the oral health of patients with cleft lip/palate (CL/P). This will be used to assess outcomes of outreach cleft programs by Global Smile Foundation (GSF) in developing countries. Methods/Description: GSF, is a registered nonprofit organization, whose volunteers have been involved with outreach cleft programs for over 3 decades in Latin America, Africa, Middle East, and Indian subcontinent. GSF conducts 6 annual missions. At each site, 75 to 365 patients are screened and 35 to 127 surgical procedures are performed along with 20 to 80 speech therapy and psychosocial consultations and 150 to 1600 dental procedures. GSF has developed a surgical database and safety guidelines to provide and ensure long-term follow-up of patients. In 2017, GSF created its own electronic medical record system (EMR). GSF now proposes a parallel dental database to follow-up the oral health of its patients. Following the 13th International Cleft Congress in Chennai, India in 2017, the "Cleft without Caries" Task force group reconfirmed the need for a standardized platform to capture and compare this information, across all countries and centers represented. A Literature review of accepted guidelines and data collection references for CL/P (ICHOM, CRANE, CLEFTSiS, etc) was carried out to identify key factors being used to capture: condition, treatment approach, timing of data collection, phenotype, demographics, and oral health of the patient.
Result(s): A dental database template is being developed for long-term follow-up on oral health of patients in outreach settings with standardized recording times. This should include: (1) Collecting data: radiographs, dental casts, facial appearance (extraoral photos), intraoral photos. (2) Treatment: dental (procedures), presurgical (nasoalveolar molding/NAM), orthodontic (interceptive/phase II,) prosthodontic treatment needed. (3) Clinical examination: occlusion (overjet, overbite, crossbite), dental caries (DMFT/ICDAS index), gingival/periodontal health (near the cleft/outside the cleft region), disturbances in dental development and dental anomalies. (4) Overall dental health: COHIP OSS (Child Oral Health Impact Profile- Oral symptoms scale) and DMFT/ICDAS score. We are currently reviewing online platforms and existing dental software for standardization and data capture.
Conclusion(s): GSF's goal is to create an all-inclusive dental database platform. Recording these parameters would allow the measuring of differences between various geographic sites, taking into account several relevant factors (eg, presurgical treatment, dental anomalies, caries risk). Once a standardized dental database platform is created, this model will be shared with other organizations and centers. These results will allow comparable measurements for long-term followup on the oral health of patients with CL/P across different cultures and countries. This will eventually lead to improved delivery of care and oral health of our patients in outreach settings
EMBASE:629084935
ISSN: 1545-1569
CID: 4071062

Eruption of Maxillary Posterior Permanent Molars following Early Conventional Le Fort III Advancement and Early Le Fort III Distraction Procedures Compared to Late Surgical Intervention

Gonchar, Marina N; Bekisz, Jonathan M; Grayson, Barry H; McCarthy, Joseph G; Shetye, Pradip R
BACKGROUND:Le Fort III advancement and/or distraction involve osteotomies and dysjunction in the region of the maxillary tuberosity in proximity to the maxillary posterior tooth buds. The purpose of this study was to determine the effect of early conventional Le Fort III advancement and/or distraction on development and eruption of the maxillary posterior permanent molars. METHODS:A retrospective review of patients diagnosed with syndromic craniosynostosis, who underwent early Le Fort III or early midface distraction and late surgical intervention, was analyzed. RESULTS:In the early conventional Le Fort III surgery group, 93 percent of maxillary second molars and 28 percent of maxillary first molars experienced a disturbance in eruption. In the early distraction group, 82 percent of maxillary second molars and 20 percent of maxillary first molars experienced a disturbance in eruption. In the control group, the late conventional Le Fort III and the late distraction groups, only 26 percent of maxillary second molars and none of maxillary first molars experienced a disturbance in eruption. CONCLUSIONS:A common disruption seen postoperatively in the early Le Fort III and distraction groups was displacement of the second molars. The majority of the displaced tooth buds were located in the maxillary sinus. Overall, the early Le Fort III surgery groups experienced more frequent disturbances for both first and second molars, with the common sequela of displacement in the maxillary sinus, leading to the question of whether presurgical planning in cases of early intervention to address midface retrusion should include extraction/enucleation of the second molar tooth buds. CLINICAL QUESTION/LEVEL OF EVIDENCE/METHODS:Therapeutic, III.
PMID: 30817661
ISSN: 1529-4242
CID: 3698572

A Prospective Randomized Blinded Trial Comparing Digital Simulation to Textbook for Cleft Surgery Education

Plana, Natalie M; Rifkin, William J; Kantar, Rami S; David, Joshua A; Maliha, Samantha G; Farber, Scott J; Staffenberg, David A; Grayson, Barry H; Diaz-Siso, J Rodrigo; Flores, Roberto L
BACKGROUND:Simulation is progressively being integrated into surgical training, yet its utility in plastic surgery has not been well described. We present a prospective, randomized, blinded trial comparing digital simulation to a surgical textbook for conceptualization of cleft-lip repair. METHODS:Thirty-five medical students were randomized to learning cleft repair using a simulator or textbook. Participants outlined markings for a standard cleft-lip repair before (pre-intervention) and after (post-intervention) 20 minutes of studying their respective resource. Two expert reviewers blindly graded markings according to a 10-point scale, on two separate occasions. Intra-rater and inter-rater reliability were calculated using intra-class correlation coefficients. Paired and independent t-tests were performed to compare scoring between study groups. A validated student satisfaction survey was administered to assess the two resources separately. RESULTS:Intra-rater grading reliability was excellent among both raters for pre-intervention and post-intervention grading (rater 1 ICC=0.94 and 0.95, respectively; rater 2 ICC=0.60 and 0.92, respectively; p<0.001). Mean pre-intervention performances for both groups were comparable (0.82±1.17 vs. 0.64±0.95; p=0.31). Significant improvement from pre-intervention to post-intervention performance was observed in the textbook (0.82±1.17 v. 3.50±1.62; p<0.001) and simulator (0.64±0.95 vs. 6.44±2.03; p<0.001) groups. However, the simulator group demonstrated a significantly greater improvement (5.81±2.01 vs. 2.68±1.49; p<0.001). Participants reported the simulator to be more effective (p<0.001) and a clearer tool (p<0.001), that allowed better learning (p<0.001) than textbooks. All participants would recommend the simulator to others. CONCLUSIONS:We present level I evidence supporting online digital simulation as a superior educational resource for novice learners, compared to traditional textbooks.
PMID: 30325894
ISSN: 1529-4242
CID: 3368362

Comparative Analysis of Three-Dimensional Nasal Shape of Casts from Patients With Unilateral Cleft Lip and Palate Treated at Two Institutions Following Rotation Advancement Only (Iowa) or Nasoalveolar Molding and Rotation Advancement in Conjunction With Primary Rhinoplasty (New York)

Hosseinian, Banafsheh; Rubin, Marcie S; Clouston, Sean A P; Almaidhan, Asma; Shetye, Pradip R; Cutting, Court B; Grayson, Barry H
OBJECTIVES/OBJECTIVE:To compare 3-dimensional nasal symmetry in patients with UCLP who had either rotation advancement alone or nasoalveolar molding (NAM) followed by rotation advancement in conjunction with primary nasal repair. DESIGN/METHODS:Pilot retrospective cohort study. MATERIALS AND METHODS/METHODS:Nasal casts of 23 patients with UCLP from 2 institutions were analyzed; 12 in the rotation advancement only group (Iowa) and 11 in the NAM, rotation advancement with primary nasal repair group (New York). Casts from patients aged 6 to 18 years were scanned using the 3Shape scanner and 3-dimensional analysis of nasal symmetry performed using 3dMD Vultus software, Version 2507, 3dMD, Atlanta, GA. Cleft and noncleft side columellar height, nasal dome height, alar base width, and nasal projection were linearly measured. Inter- and intragroup analyses were performed using t tests and paired t tests as appropriate. RESULTS:; P = .02). Intergroup analysis performed on the most sensitive linear measure, alar base width, revealed significantly less asymmetry on average in group 2 than in group 1 ( P = .013). CONCLUSION/CONCLUSIONS:This study suggests the NAM followed by rotation advancement in conjunction with primary nasal repair approach may result in less nasal asymmetry compared to rotation advancement alone.
PMID: 29578802
ISSN: 1545-1569
CID: 3011262

Proptosis Correction in Pre-Adolescent Patients With Syndromic Craniosynostosis by Le Fort III Distraction Osteogenesis

Gibson, Travis L; Grayson, Barry H; McCarthy, Joseph G; Shetye, Pradip R
Le Fort III distraction osteogenesis may be indicated in the treatment of syndromic craniosynostosis with severe midface retrusion and proptosis. This study assesses the stability of proptosis correction over 10-years.A retrospective review identified 15 patients with syndromic craniosynostosis treated by Le Fort III distraction prior to age 10 (9 males, 6 females; age 4.9 ± 1.5 years). Untreated, non-craniosynostotic age- and gender-matched controls were obtained from historical growth records. Lateral cephalometric tracings at pre-surgery (T1), immediate (T2), 1 year (T3), 5 years (T4), and 10 years (T5) (n = 11) post-distraction were superimposed using the best-fit of cranial base. Proptosis severity was defined as the horizontal distance between the Ant. Globe cephalometric point and orbital rim landmarks Orbitale and Lat. Orbit.The orbital rim advanced 10.54 ± 3.78 mm (P < 0.001) at Orbitale and 9.73 ± 4.54 mm (P > 0.001) at Lat. Orbit from T1 to T2; Ant. Globe advanced 3.13 ± 3.02 mm (p 0.001). Proptosis decreased 7.41 ± 5.29 mm (P < .001) from Orbitale and 6.60 ± 6.50 mm (p 0.002) from Lat. Orbit. Comparison to controls demonstrated phenotypic correction. In craniosynostotic patients from T2 to T5, the bony orbital rim demonstrated non-significant remodeling posteriorly and inferiorly. Anterior Globe moved 3.79 ± 1.47 mm anteriorly (P < .001), which did not differ significantly from controls. Proptosis increased by 4.18 ± 2.94 mm in craniosynostotic patients from T2 to T5.Le Fort III distraction was stable, with no significant anteroposterior relapse of the maxilla or bony orbit. Phenotypic relapse of proptosis to pre-treatment levels occurred through deficient growth of the midface, surface resorption at the orbital rim, and preservation of normal forward movement of Ant. Globe.
PMID: 29771833
ISSN: 1536-3732
CID: 3121472