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.

COVID-19 related risk factors and their association with non-syndromic orofacial clefts in five Arab countries: a case-control study.

BACKGROUND: The environmental etiology of non-syndromic orofacial clefts (NSOFCs) is still under research. The aim of this case-control study is to assess COVID-19 associated factors that may be related to the risk of NSOFC in five Arab countries. These factors include COVID-19 infection, COVID-19 symptoms, family member or friends infected with COVID-19, stress, smoking, socioeconomic status and fear of COVID-19. METHODS: The study took place in governmental hospitals in five Arab countries from November 2020 to November 2021. Controls are matched in the month of delivery and site of recruitment. A clinical examination was carried out using LASHAL classification. Maternal exposure to medication, illnesses, supplementation, COVID-19 infection during their pregestation and 1st trimester periods were evaluated using a validated questionnaire. Maternal exposure to stress was assessed using the Life Events scale, fear of covid-19 scale, family member or friend affected with covid-19 infection, pregnancy planning and threatened abortion. RESULTS: The study recruited 1135 infants (386 NSOFC and 749 controls). Living in urban areas, maternal exposure to medications 3-months pregestation, maternal exposure to any of the prenatal life events and maternal fear of COVID-19 significantly increased the risk of having a child with NSOFC. On the other hand, mothers exposed to supplementation 3-months pregestation, mothers suspected of having COVID-19 infection, family members or friends testing positive with COVID-19 significantly decreased the risk of having a child with NSOFC. CONCLUSIONS: This study suggests that NSOFC may be associated with maternal exposure to lifetime stress and COVID-19 fear in particular, with no direct effect of the COVID-19 infection itself. This highlights the importance of providing psychological support for expecting mothers during stressful events that affect populations such as the COVID-19 pandemic, in addition to the usual antenatal care.

Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.

BACKGROUND: The aim of this randomized controlled trial was to assess the effectiveness of taping alone in changing nose and lip aesthetics in infants with unilateral complete cleft lip and palate before and after surgical lip repair. METHODS: The study design was a prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. All the steps were carried out in the Department of Orthodontics of Cairo University in Egypt. Thirty-one infants with nonsyndromic unilateral complete cleft lip and palate were randomly assigned to either no treatment (control) or taping groups. In the taping group, all infants received horizontal tape between the two labial segments, aiming to decrease the cleft gap. No other interventions were performed in this group. Standardized photographs and videos were taken of the infants in both groups at the beginning of the treatment (T1), directly before surgical lip repair (T2), and 2 weeks after surgical lip repair (T3). Photographs and shots from videos were calibrated and used for outcome assessment. Blinded assessors carried out all the measurements digitally on the standardized photographs at T1, T2, and T3 using computer software. RESULTS: Significant changes in all the measurements were recorded in the taping group at T2 before surgical lip repair in comparison with the control group. At T3, no differences were found between the two groups. CONCLUSIONS: Taping is a successful intervention in changing nose and lip aesthetics before surgical lip repair. After surgical lip repair, both groups had matching aesthetics. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial.

OBJECTIVE: The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. DESIGN: A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial. SETTING: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. PARTICIPANTS: Thirty-four, nonsyndromic infants with UCLP. INTERVENTIONS: The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only. MAIN OUTCOMES MEASURES: A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment. RESULTS: Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group. CONCLUSIONS: The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.

Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.

OBJECTIVE: The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. DESIGN: A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. SETTING: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. PARTICIPANTS: Thirty-one, nonsyndromic infants with UCLP. INTERVENTIONS: The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment. MAIN OUTCOMES MEASURES: A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment. RESULTS: Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group. CONCLUSIONS: It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.

Is PRP Effective in Reducing the Scar Width of Primary Cleft Lip Repair? A Randomized Controlled Clinical Study.

OBJECTIVE: To evaluate and analyze the effect of platelet-rich plasma (PRP) injection on the scar formed after unilateral complete cleft lip scar repair using a modified Millard technique. HYPOTHESIS: An unavoidable cheiloplasty scar is a result of the wound healing process that not only influences patient self-esteem for life but also affects muscle function. DESIGN: Blind, randomized, controlled clinical trial. PATIENTS: From December 2016 to February 2018, 24 patients with unilateral complete cleft lip undergoing primary cheiloplasties were equally assigned to study and control groups. INTERVENTION: All patients were treated by modified Millard cheiloplasty. In the study group, PRP was injected into the muscle and skin layers immediately after wound closure, while the control group patients were treated with no PRP injection. OUTCOMES MEASURES: Scar width was assessed after 6 months through the muscle using ultrasonography and at the skin surface via photographs. RESULTS: Scar width showed a significant improvement in the study group. CONCLUSIONS: Injection of autologous PRP provides effective improvement of cutaneous and muscular wound healing and decreases scar tissue formation.