COVID-19 vaccine and non-syndromic orofacial clefts in five arab countries. A case-control study.

OBJECTIVES: Risk factors for non-syndromic orofacial cleft (NSOFCs) include genetic profile and environmental exposure to medication and illnesses during pregnancy. We assessed the association between the COVID-19 vaccination and the incidence of NSOFC across five Middle Eastern countries. MATERIALS AND METHODS: This multi-country, hospital-based, case-control study included infants with NSOFCs whose first 3 intrauterine months coincided with the time when pregnant women were allowed to receive COVID-19 vaccination in the countries participating in the study. Newborns with NSOFCs were examined for cleft type and their parents were interviewed for maternal exposures and COVID-19 vaccination. Controls were newborns matched to cases in gender and setting. RESULTS: The study recruited 977 (348 children with NSOFCs and 629 controls). Maternal use of nicotine (Adjusted Odds Ratio (AOR): 2.437; P = 0.044) and family history of NSOFC (AOR: 11.059; P < 0.001) increased significantly the AOR of having a child with NSOFC. On the other hand, COVID-19 vaccine administration to pregnant mothers have significantly decreased the AOR of having a child with NSOFC (AOR: 0.337; P = 0.006). CONCLUSION: This study suggests that COVID-19 vaccination is not related to NSOFC and might protect against having a child affected with such a congenital anomaly. CLINICAL RELEVANCE: The finding of this study is important for healthcare providers for considering COVID-19 vaccination for pregnant woman. Clear communication and education about the potential risks and benefits would be crucial for informed decision-making. The study's results would directly impact pregnant individuals, as they would need accurate information to make informed decisions about their health and the health of their infants.

Maternal Exposure to Stress During Covid-19 and Non-Syndromic Orofacial Clefts: A Cohort Retrospective Study.

OBJECTIVE: The coronavirus (COVID-19) pandemic presents an opportunity to study stress's effect on the development of non-syndromic orofacial clefts (NSOFCs). This study was aimed at assessing maternal stress exposure during the pregestational to first trimester pregnancy periods and the development of NSOFCs during a year of the COVID-19 pandemic. DESIGN: Cohort study of infants with NSOFCs and controls matched based on recruitment site and age. SETTING: Government hospitals in Saudi Arabia between November 2020 and November 2021. MAIN OUTCOME MEASURES: Data collection included NSOFC clinical examination and maternal stress exposure assessment using the Modified Life Events Questionnaire, the Fear of COVID-19 Scale, and a focus on the lack of pregnancy planning and a threatened miscarriage. RESULTS: Of the 557 infants recruited, 191 had NSOFCs. Logistic regression analysis with adjusted odds ratios (AORs) that removed the effects of confounders showed that any of the seven stressful life events (AOR:3.78, P < .001) and the family histories of relatives with NSOFCs (AOR:9.73, P < .001) increased the AOR for NSOFC development. In contrast, maternal folic acid (AOR:0.56, P.010), threatened miscarriage (AOR:0.17, P = .001), fear of COVID-19 (AOR:0.83, P = .038), and suspected COVID-19 infection (AOR:0.43, P = .008) decreased the AOR for NSOFC development. CONCLUSION: Along with an established risk associated with family history of birth defects, stressful life events may be a risk factor for NSOFC development. Beyond folic acid's known benefit, it may be that higher maternal health concerns contribute to increased protective health behaviors during pregnancy. Ongoing research is needed to specify the maternal risk factors for NSOFC.

Incidence of non-syndromic orofacial cleft during the COVID-19 pandemic in Saudi Arabia.

OBJECTIVES: This is the first national study to investigate the incidence of non-syndromic oro-facial clefts (NSOFC) and Pierre-Robin-Sequence in Saudi Arabia over the Covid-19 pandemic period. METHODS: All maternity hospitals (30-hospitals) in the major regions and cities of Saudi from November 2020-to-2021 were included in the study. Patients were evaluated for cleft phenotype using the LASHAL-classification system. The incidence of NSOFC in Saudi Arabia was calculated by comparing the number of NSOFCs cases born out of all live births during the study period at the included hospitals. Clinical examination was performed and information was gathered using a validated data collection form. RESULTS: In one year, 140,380 live-infants were born at the selected hospitals. Of these, 177 were diagnosed with NSOFC giving an incidence of 1.26/1,000 live-births in Saudi Arabia and the highest incidence in Medina city (2.46/1000 live-births). The incidence of cleft lip-and-palate (0.67/1000 live-births) was higher than that of cleft-palate (0.37/1000 live-births) and cleft-lip (0.22/1000 live-births). Pierre-Robin Sequence incidence was (0.04/1000 live-births). There were 21(12.1) or 23(13.2%) of NSOFC's mothers exposed or vaccinated with Covid-19, respectively. CONCLUSION: The national incidence of NSOFC in Saudi Arabia was 1.26/1000 live births with variation between phenotypes and regions in the country. In addition, to reporting Covid-19 infection prevalence and vaccine exposure among NSOFC's mothers, this study represents the first of its type to evaluate NSOFC prevalence in Saudi Arabia on a national level.

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

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

Care Barriers for Patients With Nonsyndromic Orofacial Clefts in Saudi Arabia: A Cross-Sectional Study.

OBJECTIVE: To evaluate the barriers faced by patients with nonsyndromic orofacial clefts (NSOFC) throughout their treatment course in Saudi Arabia. DESIGN: A cross-sectional study. SETTING: Eleven different governmental health care centers across Saudi Arabia. Patients: Records of pediatric patients with NSOFC. INTERVENTIONS: A questionnaire with multiple validation stages was designed to assess the barriers in care of these patients through telephonic interviews with the parents or guardians of patients with NSOFC. MAIN OUTCOME MEASURES: We identified 3 care-barrier-related factors: (1) geographic accessibility, (2) appointment availability and accessibility, and (3) scheduling-related barriers. RESULTS: Overall, 240 participants of both sexes, with orofacial cleft of various types and with various demographic characteristics (residence, family monthly income, and caregiver level of education) were included. The highest mean score of care barriers was reported for scheduling-related barriers. Overall, 186 individuals reported sometimes/often not receiving the required medical care for the following reasons: scheduling difficulties (89%; 37.1%), prolonged waiting room time (40%; 16.7%), and transportation difficulties (36%; 15.0%). A linear regression showed that parents cited late appointments as the main reason for patients with NSOFC not receiving adequate medical care. Care-barrier factors were significantly related to gender (P = .035), patient age (P < .001), place of residency (P < .001), and caregiver's level of education (P = .015). CONCLUSIONS: Gaps in the health care system directly related to common care barriers need to be addressed to ensure adequate care for patients with NSOFC.

Relationship of Velopharyngeal Insufficiency With Face Mask Therapy in Patients With Cleft Lip and Palate.

OBJECTIVE: To determine whether orthodontic/dentofacial orthopedic maxillary protraction face mask therapy induces changes in velopharyngeal functioning in a cohort of pediatric patients having cleft palate with or without cleft lip. DESIGN: Retrospective chart review. SETTING: A children's hospital in the United States. PARTICIPANTS: Forty-three pediatric patients with cleft palate, with or without cleft lip, syndromic or with isolated clefts, who received face mask therapy from January 2009 to April 2016. INTERVENTION: Clinical data were extracted for review and analysis from medical records obtained from the Cleft Database/Research Registry (CDB-RR). MAIN OUTCOME MEASURES: Pittsburgh Weighted Speech Scores (PWSS) before and after therapy. RESULTS: There was a significant increase in PWSS after face mask therapy for patients with a PWSS score of 0 prior to treatment. Patients with PWSS >0 before treatment remained largely stable after face mask therapy. Maxillary advancement was not significantly associated with change in PWSS or fistula presence/absence. CONCLUSIONS: There is an increased risk of velopharyngeal insufficiency with maxillary protraction face mask treatment in patients with cleft palate. Patient counseling and obtaining consent regarding speech changes during treatment are recommended.

Significance of Cephalometric Radiograph in Orthodontic Treatment Plan Decision.

AIM: The lateral cephalometric radiograph is a standard component of clinical records taken for orthodontic diagnosis and treatment planning. The present study was conducted to assess the utility of cephalometric radiography and analysis in modern orthodontic diagnosis and treatment planning. MATERIALS AND METHODS: A research survey was conducted at Jacksonville University School of Orthodontics. Thirty-one residents and faculty were the participants. The survey sample was collected from the university patients' pool. A survey was given to participants at two time points. At the first time point (T1), the participants were given full records without lateral cephalogram. At the second time point (T2), they were given full records with lateral cephalogram. Two measures were analyzed: (1) a change in orthodontic treatment decision and (2) a change in the orthodontic treatment plan. A traditional McNemar's test was used on paired binary data. We used the conditional logistic regression model with robust variance at a participant level to adjust for a participant-level clustering effect to test the difference in treatment decision before and after. A statistical significance was determined at p = 0.05. RESULTS: It was found that 93.6% of the treatment decisions and 70% of the extraction decisions were consistent after the introduction of lateral cephalograms. There was no statistically significant association observed between two outcome measures and the use of cephalograms (p = 0.80). CONCLUSION: Sufficient evidence does not exist to warrant lateral cephalometric radiographs be taken as a part of standard diagnostic records on every individual seeking orthodontic treatment. CLINICAL SIGNIFICANCE: Evidenced-based selection criteria for prescribing lateral cephalometric radiographs should be developed to reduce the amount of radiation exposure to the general public.

Simonart's Band: Its Effect on Cleft Classification and Recommendations for Standardized Nomenclature.

OBJECTIVE: Accurate classification of cleft lip plays an important role in communication, treatment planning, and comparison of outcomes across centers. Although there is reasonable consensus in defining cleft types, the presence of Simonart's band can make classification challenging. Our objective was to survey cleft care providers to determine what all consider to be Simonart's band, how its presence effects cleft lip classification, and to provide recommendations for standardized nomenclature. DESIGN: A multiple-choice survey was e-mailed to 1815 members of the American Cleft Palate-Craniofacial Association, assessing each respondent's definition of Simonart's band and its effect on cleft classification. Cleft classification was drawn from the ICD system diagnosis billing codes. Descriptive analysis was performed. RESULTS: Three hundred seventy-three providers completed the survey (20.5% response), the majority of whom were surgeons (61.5%); 87.1% agreed with the definition that a Simonart's band is "any soft tissue bridge located at the base of the nostril or more internally, between the segmented ridges." However, only 41.8% felt that the presence of a Simonart's band rendered a cleft lip incomplete; 54.4% felt that an alveolar cleft was the defining difference between a complete and an incomplete cleft lip. When asked to define the child with a cleft involving the upper lip that extends into the naris but interrupted by a soft tissue bridge located only at the base of the nostril or more internally, without a cleft of the alveolar ridge and palate, 61.4% classified this as an incomplete cleft lip, 32.7% as a complete cleft lip, and 5.9% as an unspecified cleft lip. CONCLUSIONS: Responses revealed wide discrepancy in the classification of cleft phenotypes and in the interpretation of the significance of anatomical components in the classification of a cleft lip. We discuss the difficulty in aligning classification based on unclear definition of terms and variable anatomic parameters. We highlight this issue in the face of a need for comparability in clinical evidence-based practices. To ensure precision and uniformity in cleft classification, we recommend that use of the term "Simonart's band" be abandoned while incorporating a notation of the integrity of the nasal sill into the LAHSHAL system. We propose a uniform definition of incomplete versus complete cleft lip, wherein a cleft lip will be classified as complete in the presence or absence of narrow bands of tissue present at the base of the nasal sill or more internally.

Instrument Development and Validation to Assess Care Barriers for Patients in Saudi Arabia with Oral Clefts.

The study objective was to construct and validate a tool to assess, measure, and evaluate the barriers and obstacles that patients with orofacial clefts (OFCs), and their families, face during treatment. The Effective Accessibility and Accommodation subscale, based on the translated Primary Care Assessment Survey and Primary Care Assessment Tool scales, was used as a reference for the questionnaire. A total of 165 parents from three main cleft referral centers in Saudi Arabia were interviewed. Questionnaire content validity was conducted by calculation of a content validity index for each item (I-CVI) as well as for the total scale (S-CVI). Reliability was tested using Cronbach's alpha. Factor analysis and principal components analysis were performed to determine the factor structure of the instrument. The final questionnaire had nine items. Rating results showed both I-CVI and S-CVI scores of 1 and Cronbach's alpha was 0.86. There were three factors (geographic accessibility, appointment availability and accessibility, and scheduling-related barriers) with eigenvalues above 1.00, which collectively accounted for 73% of the variance. In conclusion, this tool is valid and reliable to evaluate accessibility and barriers to care of patients with OFCs in Saudi Arabia.