Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort.

BACKGROUND: The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants. OBJECTIVE: This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from a substudy of platelet counts among newborns are also presented. METHODS: The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study. RESULTS: Among singleton infants in the EXPECT study, the prevalence of major congenital anomalies was 8.1%, which was similar to the 8.9% seen in the QECC. In the EXPECT study 99.1% of pregnancies resulted in live births, which was similar to 99.3% in the QECC. Premature birth was identified in 15.0% of EXPECT infants and 11.3% in the QECC. Small for gestational age was identified in 9.7% of EXPECT infants and 15.8% in the QECC. CONCLUSION: There was no evidence of an increased risk of major congenital anomalies among pregnant women exposed to omalizumab compared with a disease-matched unexposed cohort. Given the observational nature of this registry, however, an absence of increased risk with omalizumab cannot be definitively established.

Intra-operative Tranexamic Acid Administration Significantly Decreases Incidence of Postoperative Bleeding Without Increasing Venous Thromboembolism Risk After Laparoscopic Sleeve Gastrectomy: a Retrospective Cohort Study of Over 400 Patients.

BACKGROUND: There is evidence that tranexamic acid (TXA) reduces surgical bleeding and is widely used in trauma, obstetrics and other specialties. This practice is less well-established in laparoscopic sleeve gastrectomy (LSG) due to concerns surrounding venous thromboembolism (VTE); equally postoperative bleeding is a serious complication often requiring re-operation. METHODS: This retrospective cohort study compared 30-day outcomes following primary LSG in patients receiving intra-operative TXA (March 2020-July 2022) to those who did not (March 2011-March 2020). The primary outcome was postoperative bleeding (Hb < 9 g/dL) requiring transfusion or re-operation. Secondary outcomes were incidence of VTE, serious postoperative complications (Clavien-Dindo > grade 3) and death. Patients underwent standardised-protocol LSG without staple line re-enforcement under a single surgeon within the independent sector (private practice). TXA 1 g intravenous was administered immediately after a methylene blue leak test, prior to extubation. RESULTS: TXA group had 226 patients and non-TXA group had 192 patients. Mean age was 40.5 ± 10.3 and 39.1 ± 9.8 years, respectively. In the TXA group, no postoperative bleeds [versus 3 (1.6%) in non-TXA group, p = 0.0279] occurred. One staple line leak (0.4%) occurred in the TXA group compared to zero in the non-TXA group (p = ns). There was no VTE or death. CONCLUSIONS: This is the largest cohort study of intra-operative TXA in primary LSG to date, which demonstrates significant decrease in postoperative bleeding without increasing VTE risk. The authors recommend administration of TXA immediately following leak test, or removal of bougie to maximise efficacy. Data of TXA in LSG is awaited from the randomised controlled PATAS trial.

Oral and maxillofacial injuries in children: a retrospective study.

OBJECTIVES: The purpose of this retrospective epidemiological study was to determine the etiology and pattern of maxillofacial injuries in a pediatric population. MATERIALS AND METHODS: Data for pediatric maxillofacial trauma patients aged 12 years and younger who were registered at the Department of Pediatric and Preventive Dentistry, Dr. R. Ahmed Dental College and Hospital, Kolkata, India, were reviewed and examined. Patients who were treated between October 2016 and September 2018 were analyzed according to age, sex, cause of injury, frequency and site of facial fractures, and soft tissue injuries. The chi-square tests were carried out for statistical analyses with a significance level of 5%. RESULTS: Of 232 patients with a mean age of 6.77±3.25 years, there were 134 males (57.8%) and 98 females (42.2%). The overall male to female ratio was 1.39:1. The most common causes of injuries were falls (56.5%) and motor vehicle accidents (16.8%). Incidence of falls decreased significantly with age (P<0.001). Dentoalveolar injuries (61.6%) and soft tissue injuries (57.3%) were more common than facial fractures (42.7%). Mandibular fractures (82.8%) were the most common facial fractures, and perioral or lip injuries were the most prevalent injuries in our patient population. There was a positive association between facial fractures and soft tissue injury (P<0.01) (odds ratio 0.26; confidence interval 0.15-0.46). CONCLUSION: Falls were the leading cause of maxillofacial trauma in our sample of children, and the most common site of fractures was the mandible.

A retrospective study of mandibular fractures in children.

OBJECTIVES: The incidence and patterns of mandibular fractures vary by country and population age. This retrospective study evaluated the etiologies and patterns of mandibular fractures in children. MATERIALS AND METHODS: The clinical records of 89 children (45 males and 44 females) aged 0 to 12 years who presented with mandibular fractures from July 2012 to June 2016 were retrospectively reviewed. The sex, patient age, site of fracture, etiology of trauma, and monthly variations of the fractures were recorded. Descriptive statistics, the z-test and chi-square test were used for statistical analysis and the P-value was set at <0.05. RESULTS: Eighty-nine children (male-to-female ratio 1.02:1) sustained 131 mandibular fractures. Within the study sample, the 6 to 9 year age group most frequently experienced fractures (47.3%). Falls and road traffic accidents (RTA) were the two most common etiological factors that accounted for 44.9% and 24.7% of cases. The condylar fracture was the most common anatomical location (38.9%) followed by the angle (20.6%), parasymphysis (18.3%), body (15.3%), and symphysis (5.3%). A single fracture (51.7%) was more common than multiple fractures (48.3%). The month-wise distribution of mandibular fractures was fairly constant. CONCLUSION: The condylar region was the most common anatomic site for fractures; in addition, a fall and RTA were the major etiological factors for mandibular fractures. A single fracture was observed in 51.7% of patients while multiple fracture lines accounted for 48.3% of cases.

Distance M-Me: A novel parameter having significant potential as a predictor of mandibular growth.

OBJECTIVES: The purpose of the present study was to investigate the relationship of the measured distance between two mandibular points (distance M-Me) to chronological age and to find out whether the absolute values of distance M-Me could be classified age-wise into a unique range, which could be directly read for predicting the stage of mandibular growth. METHODS AND MATERIALS: The study sample consists of lateral cephalometric records of 65 patients (34 females and 31 males; age range: 6-21 years). Chronological age was calculated in decimal years. Lateral cephalograms were assessed by two independent examiners. Points M and Me were located on the lateral cephalograms, and linear distance between them was measured. RESULTS: Pearson product-moment correlation coefficients showed a high correlation between chronological age and distance M-Me (0.746 for females and 0.869 for males, p < 0.01). When the values of distance M-Me were compared with chronological age, it was possible to make four age groups (for females and males separately), where each group showed a unique range of value for distance M-Me. The values increased with increasing age. CONCLUSIONS: Increase in value of distance M-Me with age, showing reduced individual variation, depicts a well-conserved linear dimension. Values of distance M-Me can be directly read for predicting the stage of mandibular growth and can be used as a valuable adjunct or substitute to chronological age.

Gorham's disease of mandible--a rare case presentation in pediatric patient.

Gorham's disease or vanishing bone disease is a rare, progressive musculoskeletal disorder characterized by resorption of bone matrix, and later replaced by fibrous connective tissue. The disease has no specific predilection for age, gender, or race. The most common sites of involvement are the shoulder and pelvic bones. To date, nearly 50 cases of Gorham's disease with maxillofacial involvement have been reported in the literature. The etiology of Gorham's disease is not known, clinical features are variable, and prognosis is generally good unless vital structures are involved. Due to the rarity of the condition, no definite treatment protocol exists for this disorder. Here, we described a pediatric case of Gorham's disease with mandibular involvement.

A comparative evaluation of dental caries status among hearing-impaired and normal children of Malda, West Bengal, evaluated with the Caries Assessment Spectrum and Treatment.

CONTEXT: Dental caries is one of the major modern-day diseases of dental hard tissue. It may affect both normal and hearing-impaired children. AIMS: This study is aimed to evaluate and compare the prevalence of dental caries in hearing-impaired and normal children of Malda, West Bengal, utilizing the Caries Assessment Spectrum and Treatment (CAST). SETTINGS AND DESIGN: In a cross-sectional, case-control study of dental caries status of 6-12-year-old children was assessed. SUBJECTS AND METHODS: Statistically significant difference was found in studied (hearing-impaired) and control group (normal children). In the present study, caries affected hearing-impaired children found to be about 30.51% compared to 15.81% in normal children, and the result was statistically significant. Regarding individual caries assessment criteria, nearly all subgroups reflect statistically significant difference except sealed tooth structure group, internal caries-related discoloration in dentin, and distinct cavitation into dentine group, and the result is significant at P < 0.05. STATISTICAL ANALYSIS USED: Statistical analysis was carried out utilizing Z-test. RESULTS: Statistically significant difference was found in studied (hearing-impaired) and control group (normal children). In the present study, caries effected hearing-impaired children found about 30.51% instead of 15.81% in normal children, and the result was statistically significant (P < 0.05). Regarding individual caries assessment criteria, nearly all subgroups reflect statistically significant difference except sealed tooth structure group, internal caries-related discoloration in dentin, and distinct cavitation into dentine group. CONCLUSIONS: Dental health of hearing-impaired children was found unsatisfactory than normal children when studied in relation to dental caries status evaluated with CAST.

Anomalies in primary dentition: Their distribution and correlation with permanent dentition.

BACKGROUND: Anomalies in primary dentition are often found to be associated with anomalies in permanent dentition. AIMS: This study was performed to evaluate the prevalence of supernumerary teeth, hypodontia, double teeth, and talon cusp in the primary dentition, and their effect on succedaneous permanent teeth. MATERIALS AND METHODS: In this prospective cross-sectional study, we clinically investigated 2757 Bengali speaking nursery children (1474 girls and 1283 boys), of age four to six years, at their respective schools, and the presence of supernumerary teeth, hypodontia, double teeth, and talon cusp in the primary dentition were recorded. Children with anomalous primary teeth were further subjected to periapical and panoramic radiographic examination, to determine the status of the underlying permanent teeth. RESULTS: The total prevalence of all anomalies in this study was 1.8%. A total of 38 children (21 girls and 17 boys) had anomalies. The prevalence of anomalies was as follows: Supernumerary teeth (0.4%), hypodontia (0.5%), double teeth (0.4%), and talon cusp (0.07%), in both sexes combined. Radiographic examination showed 50% of the patients (19 children) had anomalies in the permanent dentition. CONCLUSIONS: Anomalies in primary dentition exhibited a correlation with anomalies in permanent dentition.

Enamel hypoplasia of primary canine: Its prevalence and degree of expression.

BACKGROUND: Enamel hypoplasia is a unique lesion showing wide variations in prevalence among populations. The present study aimed to evaluate frequency and degree of expression of enamel hypoplasia of primary canine in populations living in the eastern part of India. MATERIALS AND METHODS: A prospective cross sectional study was performed in randomly selected 3539 school children. Labial surfaces of all primary canines were examined. The frequency and degree of expression of enamel hypoplasia between different ethnic groups were recorded. Based on the location of the defect on the tooth surfaces, the lesions were divided as prenatal, perinatal, and postnatal according to stage of mineralization. Statistical analysis was carried out using Chi square test. RESULTS: The overall prevalence of primary canine hypoplasia was 10.3%. The mandibular primary canines were significantly (P = 0.03) more frequently affected than maxillary canines among different ethnic groups. The side difference among populations was not significant (P = 0.96) statistically. In 8.5% Bengali population, 7% Rajbangsi population, and 9.4% in other group of population, the defect occurred prenatally. Most of the defects, 64.7% in Bengali, 66.1% in Rajbangsi, and 58.8% in others occurred during perinatal stage of mineralization. The defect occurred postnatally in 26.8%, 26.7%, and 31.8% in Bengali, Rajbangsi, and in other group of population respectively. CONCLUSION: The overall prevalence of primary canine hypoplasia was 10.3%. The mandibular primary canines were more frequently affected (P = 0.03) than their maxillary counterparts among populations. Most of the defects correspond to perinatal stage of mineralization.