Safety analysis of Oseltamivir and Baloxavir Marboxil after market approval: a pharmacovigilance study based on the FDA adverse event reporting system.

BACKGROUND AND OBJECTIVES: Amidst limited influenza treatment options, evaluating the safety of Oseltamivir and Baloxavir Marboxil is crucial, particularly given their comparable efficacy. This study investigates post-market safety profiles, exploring adverse events (AEs) and their drug associations to provide essential clinical references. METHODS: A meticulous analysis of FDA Adverse Event Reporting System (FAERS) data spanning the first quarter of 2004 to the fourth quarter of 2022 was conducted. Using data mining techniques like reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multiple Gamma Poisson Shrinkage, AEs related to Oseltamivir and Baloxavir Marboxil were examined. Venn analysis compared and selected specific AEs associated with each drug. RESULTS: Incorporating 15,104 Oseltamivir cases and 1,594 Baloxavir Marboxil cases, Wain analysis unveiled 21 common AEs across neurological, psychiatric, gastrointestinal, dermatological, respiratory, and infectious domains. Oseltamivir exhibited 221 significantly specific AEs, including appendicolith [ROR (95% CI), 459.53 (340.88 ∼ 619.47)], acne infantile [ROR (95% CI, 368.65 (118.89 ∼ 1143.09)], acute macular neuroretinopathy [ROR (95% CI), 294.92 (97.88 ∼ 888.64)], proctitis [ROR (95% CI), 245.74 (101.47 ∼ 595.31)], and Purpura senile [ROR (95% CI), 154.02 (81.96 ∼ 289.43)]. designated adverse events (DMEs) associated with Oseltamivir included fulminant hepatitis [ROR (95% CI), 12.12 (8.30-17.72), n=27], ventricular fibrillation [ROR (95% CI), 7.68 (6.01-9.83), n=64], toxic epidermal necrolysis [ROR (95% CI), 7.21 (5.74-9.05), n=75]. Baloxavir Marboxil exhibited 34 specific AEs, including Melaena [ROR (95% CI), 21.34 (14.15-32.18), n = 23], cystitis haemorrhagic [ROR (95% CI), 20.22 (7.57-54.00), n = 4], ileus paralytic [ROR (95% CI), 18.57 (5.98-57.71), n = 3], and haemorrhagic diathesis [ROR (95% CI), 16.86 (5.43-52.40)), n = 3]. DMEs associated with Baloxavir Marboxil included rhabdomyolysis [ROR (95% CI), 15.50 (10.53 ∼ 22.80), n = 26]. CONCLUSION: Monitoring fulminant hepatitis during Oseltamivir treatment, especially in patients with liver-related diseases, is crucial. Oseltamivir's potential to induce abnormal behavior, especially in adolescents, necessitates special attention. Baloxavir Marboxil, with lower hepatic toxicity, emerges as a potential alternative for patients with liver diseases. During Baloxavir Marboxil treatment, focused attention on the occurrence of rhabdomyolysis is advised, necessitating timely monitoring of relevant indicators for those with clinical manifestations. The comprehensive data aims to provide valuable insights for clinicians and healthcare practitioners, facilitating an understanding of the safety profiles of these influenza treatments in real-world scenarios.

The Impact of Hippocampal-Sparing Whole-Brain Radiotherapy on Survival and Cognitive Function in Patients with Brain Metastases.

Objective: To explore the effects on cognitive function and survival time of whole-brain intensity-modulated radiotherapy using radiotherapy equipment to protect the hippocampus. Methods: Thirty-six patients with brain metastases treated at Qianjiang Central Hospital were enrolled in this study from January 2019 to September 2022. The patients were randomly divided into 2 groups: 15 patients received hippocampal-protection whole-brain radiotherapy, and 21 patients received conventional whole-brain radiotherapy. The Montreal Cognitive Assessment was used to evaluate the cognitive function of patients before and 24 hours, 2 months, 6 months, and 12 months after radiotherapy. Cognitive dysfunction and survival time were compared between the 2 groups. Results: The overall mean differences in the Montreal Cognitive Assessment scores between the hippocampal-protection group and the conventional whole-brain radiotherapy group were statistically significant at 6 months (P = .006) and 12 months (P = .04) after radiotherapy. The median overall survival was 16 months (95% CI, 11.54-20.46) for the hippocampal-protection group and 14 months (95% CI, 12.9-15.21) for the conventional whole-brain radiotherapy group (P = .578). The median progression-free survival was 12 months (95% CI, 9.74-14.26) for the hippocampal-protection group and 9 months (95% CI, 6.60-11.44) for the conventional whole-brain radiotherapy group (P = .494). Conclusion: Whole-brain radiotherapy for protecting the hippocampus can delay cognitive dysfunction in patients to some extent.

Three-dimensional positioning of the maxilla using novel intermediate splints in maxilla-first orthognathic surgery for correction of skeletal class III deformity.

OBJECTIVES: Successful orthognathic surgery requires accurate transfer of the intraoperative surgical plan. This study aimed to (1) evaluate the surgical error of a novel intermediate splint in positioning the maxilla during maxilla-first orthognathic surgery and (2) determine factors influencing surgical error. MATERIALS AND METHODS: This prospective study examined 83 patients who consecutively underwent Le Fort I osteotomy for correction of skeletal class III deformity using a novel intermediate splint and a bilateral sagittal split osteotomy. Surgical error was the outcome variable, measured as the difference in postoperative translational and rotational maxillary position from the virtual plan. Measures included asymmetry, need and amount for mandibular opening during fabrication of intermediate splints, and planned and achieved skeletal movement. RESULTS: Mean errors in translation for vertical, sagittal, and transversal dimensions were 1.0 ± 0.7 mm, 1.0 ± 0.6 mm, and 0.7 ± 0.6 mm, respectively; degrees in rotation for yaw, roll, and pitch were 0.8 ± 0.6, 0.6 ± 0.4, and 1.6 ± 1.1, respectively. The transverse error was smaller than sagittal and vertical errors; error for pitch was larger than roll and yaw (both p < 0.001). Error for sagittal, transverse, and roll positioning was affected by the achieved skeletal movement (roll, p < 0.05; pitch and yaw, p < 0.001). Surgical error of pitch positioning was affected by planned and achieved skeletal movement (both p < 0.001). CONCLUSIONS: Using the novel intermediate splint when performing Le Fort I osteotomy allowed for accurate positioning of the maxilla. CLINICAL RELEVANCE: The novel intermediate splint for maxillary positioning can be reliably used in clinical routines.

Stability between single and segmental maxillary osteotomies in bimaxillary surgery for cleft-associated class III deformity: a CBCT study.

OBJECTIVE: Segmental Le Fort I osteotomy through the cleft is a common strategy to narrow the alveolar cleft in adults. This study compared skeletal stability between single and segmental Le Fort I osteotomies in patients with unilateral cleft lip and palate (UCLP). MATERIALS AND METHODS: This retrospective analysis examined 45 adults with complete UCLP-associated class III deformities who underwent bimaxillary surgery with either single (n = 30) or segmental (n = 15) Le Fort I advancement. Cone beam computed tomography (CBCT) scans of the facial skeleton were acquired before surgery, 1-week postsurgery, and at follow-up. Measures of landmarks from the CBCT images for the two treatment groups were compared for translation (left/right, posterior/anterior, superior/inferior) and rotation (yaw, roll, pitch). RESULTS: Postsurgery, the downward movement of the maxilla was larger in the segmental group than the single group. At follow-up, the maxilla moved backward in both groups, and upward in the segmental group. The mandible moved forward and upward and rotated upward in both groups. The amount of upward movement and rotation was larger in the segmental group than the single group. CONCLUSIONS: Two years after bimaxillary surgery in patients with UCLP-associated class III deformity, greater relapse was found after segmental Le Fort I osteotomies in vertical translation of the maxilla and mandible, and pitch rotation of the mandible compared with single Le Fort I osteotomies. CLINICAL RELEVANCE: The vertical relapse of the maxilla was larger after segmental Le Fort I advancement compared with single Le Fort I advancement in clefts.

Site and severity of facial asymmetry after bimaxillary surgery for class III deformity: a case-control study.

OBJECTIVES: The study aimed (1) to evaluate the site and severity of facial asymmetry in Class III patients before and after bimaxillary surgery, and (2) to identify the influence of initial severity and positional jaw asymmetry on residual facial asymmetry. MATERIALS AND METHODS: Preoperative and postoperative cone-beam computed tomography of 65 patients with Class III facial asymmetry who underwent bimaxillary surgery were evaluated. Five midline and 14 paramedian facial soft tissue landmarks were identified to assess facial asymmetry. The outcomes were compared to a control group consisting of 30 age- and gender-matched Class I subjects. The postoperative positional jaw asymmetry (i.e., shift, roll, yaw) of each osteotomy segment (maxilla, mandible, chin, ramus) was also measured. RESULTS: Before surgery, the asymmetry was more severe at the chin, middle and lower contour. Bimaxillary surgery effectively corrected facial asymmetry, particularly in achieving normalization of chin deviation. However, significant asymmetry persisted postoperatively in the middle and lower contour (p < 0.001 and p < 0.01, respectively), which was affected by the positional ramus asymmetry in the roll and shift. CONCLUSIONS: Deviation of the chin, middle and lower contour contributed significantly to overall facial asymmetry in Class III asymmetry. Despite normalization of the chin deviation after bimaxillary surgery, asymmetry persisted at the middle and lower contour, primarily as the result of insufficient correction of the positional ramus asymmetry. CLINICAL RELEVANCE: Understanding the residual asymmetry after bimaxillary surgery is important for minimizing deviation and optimizing the surgical planning for its correction.

Post-marketing safety concerns with nirmatrelvir: A disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System.

AIMS: Nirmatrelvir is an antiviral drug with a novel mechanism of action, targeting the 3-CL protease, and is used in the treatment of COVID-19. However, the potential side effects have not yet been fully studied. The aim of this study was to identify potential safety signals of nirmatrelvir by analysing post-marketing safety data based on the largest publicly available worldwide pharmacovigilance database. METHODS: We analysed nirmatrelvir adverse events to identify and characterize relevant safety signals based on the FDA Adverse Event Reporting System database in 2022. The case/non-case approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for adverse events (AEs) that numbered 4 or more. RESULTS: A total of 26 846 cases were included. Disease recurrence (ROR [95% CI] = 413.2 [395.6-431.59]), dysgeusia (ROR [95% CI] = 110.84 [106.04-115.85]), anosmia (ROR [95% CI] = 15.21 [12.76-18.11]), ageusia (ROR [95% CI] = 9.80 [8.50-11.3]) and urticaria (ROR [95% CI] = 1.91 [1.69-2.17]) were the main safety signals. In addition, abdominal pain upper and skin toxicity were two specific safety signals of nirmatrelvir. In the pregnant population, there was a significant increased ROR for life-threatening conditions (ROR [95% CI] = 8.00 [1.77-36.20]). CONCLUSIONS: Our study identified that the main and specific safety signals of nirmatrelvir were disease recurrence, dysgeusia, abdominal pain upper and skin toxicity. Clinicians and pharmacists should be vigilant of these AEs, although differentiating between COVID-19 symptoms and AEs can be challenging. Notably, a potential safety concern of nirmatrelvir should be a warning based on a small number of events in the pregnant population. However, the available data are insufficient, and further continued pharmacovigilance and surveillance is needed to fully understand this issue.

Outcomes of alveolar cleft repair in complete cleft lip and palate after tertiary gingivoperiosteoplasty and segmental Le Fort I osteotomy.

OBJECTIVES: Gingivoperiosteoplasty is often used for reconstruction of alveolar defects in infants with cleft lip and palate. This study aimed to examine outcomes of tertiary gingivoperiosteoplasty, which has not previously been investigated. MATERIALS AND METHODS: This prospective study included 11 adults with complete cleft lip and palate (n = 12 sites) who consecutively underwent segmental Le Fort I osteotomy and concomitant gingivoperiosteoplasty for correction of skeletal class III deformity, nasoalveolar fistula and alveolar cleft. Outcomes included clinical and radiographic evaluations of gingivoperiosteoplasty at the time of osteotomy (presence of nasoalveolar fistula, residual cleft defect and unsupported root ratio of cleft-adjacent teeth), and determination of influencing factors for the clinical success of alveolar cleft repair. Study variables included age, gender, pre-surgical orthodontic treatment and alveolar cleft width of cleft-adjacent canine and angulation between cleft-adjacent teeth before surgery and 1-week postsurgery. RESULTS: Posttreatment, no nasoalveolar fistula remained. The residual cleft defect decreased significantly (p < 0.01). The unsupported root ratio of cleft-adjacent teeth did not differ (p > 0.05); eight cleft sites reached Bergland I or II (67% success). One-week postsurgery, the minimal alveolar cleft width of cleft-adjacent canine was significantly less in the success group compared with the failed group (p = 0.01). CONCLUSIONS: Tertiary gingivoperiosteoplasty and segmental Le Fort I osteotomy decreased nasoalveolar fistulas and induced alveolar bone formation. The minimal alveolar cleft width immediately after surgery was the major influencing factor of clinical success. CLINICAL RELEVANCE: Segmental Le Fort I osteotomy with simultaneous gingivoperiosteoplasty efficaciously repairs adult alveolar clefts.

Lip and tongue strength associated with chewing patterns in aging population.

BACKGROUND: Improving chewing function of older adults increases the health-related quality of life. Few studies indicated the correlation between tongue, lip strength on masticatory performance in older people. The study aimed to investigate the association between lip, tongue strength on chewing pattern in aging population. METHODS: The older adults had independent daily intake without assistance were enrolled. They had intact dentition and no periodontitis. To estimate the number of chewing strokes and chewing time by consuming a cornstarch cookie were used to represent chewing pattern. Lip and tongue pressure were evaluated with an Iowa Oral Performance Instrument. Linear regression analysis was used to analyze the lip and tongue pressure associated with the chewing time and strokes. Spearman's correlation analysis was utilized to evaluate the associations among chewing time and chewing strokes or lip and tongue pressure. RESULTS: 35 women and 35 men with an average age of 73.2 years were investigated. Tongue pressure was significantly related to the chewing time and the number of chewing strokes (p = 0.01 and 0.03). There was a close association between chewing time and the number of chewing strokes (p < 0.0001). The correlation between lip and tongue pressure was significant (p < 0.0001). CONCLUSION: The tongue strength significantly related to chewing ability in aging population. Increasing the tongue strength greatly reduced the number of chewing strokes and chewing time. Good masticatory ability could increase the motor function of tongue; raising the tongue strength might be able to improve mastication in older adults.

Is the pattern of mandibular asymmetry in mild craniofacial microsomia comparable to non-syndromic class II asymmetry?

OBJECTIVES: To compare the characteristics of mandibular asymmetry in patients with unilateral craniofacial microsomia (CFM) and class II asymmetry. MATERIALS AND METHODS: Pretreatment cone-beam computed tomography of consecutive adults with Pruzansky-Kaban type I and IIA CFM (CFM group) was analyzed by 3D cephalometry. Fourteen mandibular landmarks and two dental landmarks were identified. The mandibular size and positional asymmetry were calculated by using landmark-based linear and volumetric measurements, in terms of asymmetry ratios (affected/non-affected side) and absolute differences (affected - non-affected side). Results were compared with non-syndromic class II with matched severity of chin deviation (Class II group). Statistical analyses included independent t test, paired t test, chi-square test, and ANOVA. RESULTS: CFM group (n, 21; mean age, 20.4 ± 2.5 years) showed significantly larger size asymmetry in regions of mandibular body, ramus, and condyle compared to Class II group (n, 21; mean age, 27.8 ± 5.9 years) (p < 0.05). The curvature of mandibular body was asymmetric in CFM. Regarding the positional asymmetry of mandibular body, while a comparable transverse shift and a negligible yaw rotation were found among the two groups, the roll rotation in CFM was significantly greater as well as the occlusal (6.06° vs. 4.17°) and mandibular (7.84° vs. 2.80°) plane cants (p < 0.05). CONCLUSIONS: Mild CFM showed significantly more severe size asymmetry and roll rotation in mandible than non-CFM class II asymmetry. CLINICAL RELEVANCE: To improve the mandibular size and positional asymmetry in CFM, adjunct hard tissue augmentation or reduction in addition to OGS orthodontics with a meticulous roll and yaw planning is compulsory, which is expected to be distinct from treating non-CFM class II asymmetry.

Skeletal stability after bimaxillary surgery with surgery-first approach for class III asymmetry is not related to virtual surgical occlusal contact.

OBJECTIVES: Surgery-first orthognathic surgery is rarely used in class III asymmetry due to concerns of reduced skeletal stability from unstable surgical occlusion. This study aimed to evaluate if skeletal stability after surgery-first orthognathic surgery is related to virtual surgical occlusal contact or surgical change. MATERIALS AND METHODS: We studied 58 adults with class III asymmetry, consecutively corrected by Le Fort I osteotomy and bilateral sagittal split osteotomy using a surgery-first approach. Dental casts were manually set to measure virtual surgical occlusal contact including contact distribution, contact number, and contact area. Cone-beam computed tomography taken before treatment, 1-week post-surgery, and after treatment was used to measure surgical change and post-surgical stability of the maxilla and mandible in translation (left/right, posterior/anterior, superior/inferior) and rotation (pitch, roll, yaw). The relationship between skeletal stability and surgical occlusal contact or surgical change was evaluated with correlation analysis. RESULTS: Significant instability was found in the mandible but not in the maxilla. No correlation was found between the maxillary or mandibular stability and surgical occlusal contact (all p > 0.01). However, a significant correlation was found between the maxillary (roll and yaw) or mandibular (shift, roll and pitch) stability and its surgical change (all p < 0.001). CONCLUSIONS: In correction of class III asymmetry with surgery-first bimaxillary surgery, the skeletal stability is not related to the virtual surgical occlusal contact, but surgical skeletal change. CLINICAL RELEVANCE: Planned over-correction is a reasonable option for correction of severe shift or roll mandibular asymmetry in bimaxillary surgery for class III deformity.

Type of mandibular asymmetry affects changes and outcomes of bimaxillary surgery for class III asymmetry.

OBJECTIVES: Various methods have been used to classify class III asymmetry. There is little information on the use of an asymmetry index to examine soft tissue changes and outcomes for patients with class III asymmetry. This study aimed to (1) evaluate soft tissue changes and outcomes for three types of mandibular asymmetry and (2) determine if measures are associated with type of asymmetry. MATERIALS AND METHODS: Adults who consecutively underwent bimaxillary surgery using surgery-first approach for correction of class III asymmetry were divided into three groups based on type of mandibular asymmetry. This previously reported classification system is simple and mutually independent, categorizing mandibular asymmetry according to the amount and direction of ramus asymmetry relative to menton deviation: patients with a larger transverse ramus distance on the menton deviation side were divided into group 1 and group 2; group 1 (n = 45) exhibited a menton deviation larger than ramus discrepancy; group 2 (n = 11) exhibited a menton deviation less than ramus discrepancy; group 3 (n = 22) had larger transverse ramus distance contralateral to the side of the menton deviation. Soft tissue facial asymmetry indices, calculated from cone beam computed tomography images, assessed midline and contour asymmetry presurgery, changes postsurgery, and outcomes. RESULTS: Compared with groups 1 and 2, the presurgery index for contour and midline asymmetry was smallest for group 3. All the three groups had significant improvement in midline asymmetry postsurgery, and outcome measures were good; there were no differences between groups. However, contour asymmetry only improved significantly for groups 1 and 2. The outcome for contour asymmetry was fair for groups 1 and 3 and poor for group 2. CONCLUSIONS: Bimaxillary surgery significantly improved facial midline asymmetry. The type of mandibular asymmetry was associated with postsurgical changes and outcomes for contour asymmetry. CLINICAL RELEVANCE: Understanding the types of mandibular asymmetry could help clinicians to develop treatment plans and predict treatment changes and outcomes.

Skeletal and upper airway stability following modified maxillomandibular advancement for treatment of obstructive sleep apnea in skeletal class I or II deformity.

OBJECTIVES: Maxillomandibular advancement (MMA) is an effective short-term treatment for obstructive sleep apnea (OSA). This study aimed to evaluate the long-term stability of the facial skeleton, upper airway, and its surrounding structures, as well as improvement in OSA following MMA. MATERIALS AND METHODS: Thirty-one adults with moderate-to-severe OSA underwent surgery-first modified MMA as primary surgery. Polysomnography and cone-beam computed tomography were obtained pre-surgery, early post-surgery, and at follow-up (i.e., ≥ 2 years post-surgery). Image analysis software assessed the facial skeleton, upper airway, and its surrounding structures. RESULTS: Early post-surgery, apnea-hypopnea index (AHI) had decreased significantly (p < 0.001) and the minimum oxygen saturation (MSAT) increased (p = 0.001), indicating significant improvement in OSA. At follow-up, the AHI and MSAT remained stable. However, the anterior maxilla, soft palate, and tongue moved backward while the hyoid moved downward. There was also a significant decrease in the minimal cross-sectional area of the oropharynx. The reduction in AHI was significantly related to the anterior movement of the anterior maxilla and tongue, inferior movement of the posterior maxilla, and superior movement of the soft palate tip. CONCLUSIONS: The improvement of OSA after modified MMA remained stable for at least 2 years following treatment, despite the relapse of the facial skeleton, upper airway, and its surrounding structures. The reduction of AHI was not related to changes in the caliber of the upper airway but to the movement of the maxilla, soft palate, and tongue. Clinical relevance Modified MMA is clinically effective for long-term treatment of patients with moderate-to-severe OSA.

Comparison of stability and outcomes of surgery-first bimaxillary surgery for skeletal class III deformity between unilateral and bilateral cleft lip and palate.

OBJECTIVES: Some adults with cleft lip and palate (CLP) require orthognathic surgery due to skeletal deformity. This prospective study aimed to (1) compare skeletal stability following bimaxillary surgery for correction of class III deformity between patients with unilateral CLP (UCLP) and bilateral CLP (BCLP), and (2) identify risk factors of stability. MATERIALS AND METHODS: Adults with CLP and skeletal class III deformities who underwent surgery-first bimaxillary surgery were divided into two groups according to cleft type: UCLP (n = 30) and BCLP (n = 30). Skeletal stability was assessed with measures from cone beam computed tomography images of the maxilla and mandible taken before treatment, 1-week and ≥ 1 year postsurgery for translation (left/right, posterior/anterior, superior/inferior) and rotation (yaw, roll, pitch); multiple regression analysis examined risk factors. RESULTS: At follow-up, the maxilla moved upwards in both groups, and backwards in the UCLP group. The mandible moved forward and upward, shifted to the cleft (deviated) side, and rotated upward in both groups. The amount of surgical advancement was a risk factor for sagittal stability in the maxilla (ß = -0.14, p < 0.05). The mandible had three risk factors for sagittal stability: age (ß = -0.23, p < 0.05), surgical team (ß = -1.83, p < 0.05), and amount of surgical setback (ß = -0.32, p = 0.001). CONCLUSIONS: Two years after bimaxillary surgery, patients with UCLP had a higher sagittal relapse of the maxilla compared with patients with BCLP, which was due to a greater surgical advancement in the patients with UCLP. CLINICAL RELEVANCE: Surgery-first bimaxillary surgery results in favorable treatment outcomes for correction of cleft-related class III deformity. Severity of jaw discrepancy and surgeons should be considered in the surgical design of overcorrection.

The correlation between two occlusal analyzers for the measurement of bite force.

BACKGROUND: Occlusal force represents masticatory function. Using quantifiable occlusal indicators provides a more objective occlusal force evaluation. In the recent dental practice, digital methods such as the Dental Prescale II (DP2, GC Corp., Tokyo, Japan) and T-scan (T-Scan III v8; Tekscan Inc.) are commonly used in clinics to evaluate treatment outcomes. The T-scan provides the relative bite force (%) compared to the maximal bite force on individual teeth or the unilateral arch. The DP2 can quantify occlusal force, measured in newtons (N), on the half arch or the overall bite, but it is difficult to identify the bite force on an individual tooth. It is difficult to select a device that fulfils all the requirements to record occlusal force. This study aimed to investigate the association between the bite measured by the DPS2 and T-scan to determine whether the measured bite force is comparable through calculation. METHODS: A total of 80 healthy adults, including 41 women and 39 men with a mean age of 38.2, were requested to bite pressure sensitive film sheets ten minutes apart. Linear regression analysis was used to estimate the measured bite force by the DP2 and T-scan. RESULTS: There was a significant positive correlation between the occlusal force measured by the DP2 and T-scan (P < 0.01) when intercept was equal to zero as confounders were adjused. These results provided the comparability of the measured occlusal forces determined by the DP2 and T-scan. CONCLUSION: The estimated bite force determined by DP2 and T-Scan is convertible using the linear equation from this study to increase the value for clinical applications. The estimated bite force from the two quantifiable occlusal indicators are comparable. The two commercially available quantifiable occlusal indicators can be fully adapted to all clinical requirements according to this result.

The impact of timing and modalities of dental prophylaxis on the risk of 5-fluorouracil-related oral mucositis in patients with head and neck cancer: a nationwide population-based cohort study.

PURPOSE: This study investigated the impact of dental prophylaxis on 5-fluorouracil (5-FU)-related oral mucositis (OM) according to the head and neck cancer (HNC) locations and treatment times. METHODS: A total of 13,969 HNC participants, including 482 5-FU-related OM subjects and 13,487 comparisons were enrolled from the Longitudinal Health Insurance Database for Catastrophic Illness Patients of Taiwan between 2000 and 2008. All subjects were stratified into subgroups based on the times to perform chlorhexidine use, scaling, and fluoride application before 5-FU administration. The dental prophylaxis related to 5-FU-related OM was estimated by multiple logistic regression and represented with odds ratio (OR) and 95% confidence interval (CI). RESULTS: Fluoride gel application and scaling significantly impacted on OM development (p < 0.001), and the joint effect of fluoride gel and scaling induced 5-FU-related OM (OR = 3.46, 95% CI = 2.39-5.01). The risk of OM was raised 2.25-fold as scaling within 3 weeks before 5-FU-related chemotherapy (95% CI = 1.81-2.81), and a 3.22-fold increased risk of OM while fluoride gel was applied during 5-FU-related treatment (95% CI = 1.46-7.13). CONCLUSION: Dental prophylaxis significantly affected 5-FU-related OM in the HNC population. A short interval between dental scaling or fluoride application and 5-FU administration may be associated with higher prevalence of OM. Scaling simultaneously combined with chlorohexidine promoted 5-FU-related OM in specific HNC patients excluding the oral cancer and nasopharyngeal cancer population. Proper timing of the prophylactic dental treatments prior to 5-FU therapy could reduce the risk to develop 5-FU-related OM.

Three-Dimensional Analysis of the Condylar Hypoplasia and Facial Asymmetry in Craniofacial Microsomia Using Cone-Beam Computed Tomography.

PURPOSE: To assess the condylar hypoplasia and its correlation with craniofacial deformities in adults with unilateral craniofacial microsomia (CFM). METHODS: Pretreatment cone-beam computed tomography scans of consecutive adults (mean age: 20.4 ± 3.0 years; range: 17.3 to 31.4 years) with Pruzansky-Kaban type I and IIA CFM were reconstructed in 3D. Both condyles were segmented. Asymmetry ratios (affected side/contralateral side) of condylar volume were calculated to indicate the extent of condylar hypoplasia. 3D cephalometry was performed to quantify the maxillomandibular morphology and facial asymmetry. The correlations in between were assessed by using Pearson's or Spearman's correlation coefficients. RESULTS: Thirty-six subjects were enrolled, consisting of 22 subjects with Pruzansky-Kaban type I and 14 subjects with type IIA. The condyles in type IIA group were significantly more hypoplastic in height (asymmetry ratio: 40.69 vs 59.95%, P = .006) and volume (18.16 vs 47.84%, P < .001) compared to type I group. Type IIA group had a significantly smaller SNB value than type I group (72.94° vs 77.41°, P = .012), and a significantly greater facial asymmetry (P < .05). The hypoplastic extent of condylar volume and Pruzansky-Kaban types were significantly correlated with SNB (r = 0.457 and ρ = -0.411, respectively), upper incisor deviation (r = -0.446 and ρ = 0.362), chin deviation (r = -0.477 and ρ = 0.527), upper occlusal plane cant (r = -0.672 and ρ = 0.631), and mandibular plane cant (r = -0.557 and ρ = 0.357, P < .05). CONCLUSION: For unilateral CFM adults, greater condylar hypoplasia in volume along with more severe mandibular retrusion and facial asymmetry objectively indicated a higher scale of Pruzansky-Kaban classification (type IIA). These quantitative distinctions are expected to enhance the diagnostic reliability of CFM.

Patient satisfaction and quality of life after orthodontic treatment for cleft lip and palate deformity.

OBJECTIVES: Patients with cleft lip-cleft palate (CLP) often require orthodontic treatment, with or without orthognathic surgery. Patient satisfaction is the most important outcome parameter in orthodontic treatment. This study aimed to (1) determine patient satisfaction and quality of life (QoL) after orthodontic treatment and (2) identify associated factors. MATERIAL AND METHODS: This prospective cross-sectional study recruited patients with CLP who had completed orthodontic treatment at a craniofacial center in Taiwan. Participants (N=213) had received treatment for unilateral CLP (n=99), bilateral CLP (n=50), cleft lip and alveolus (n=39), and isolated cleft palate (n=25). Self-report questionnaires evaluated satisfaction with appearance and QoL; multiple regression analysis examined associated factors. Participants' expectations of treatment results were also reported. RESULTS: Participants reported moderate satisfaction with facial appearance and QoL. Satisfaction with treatment was lower or much lower than expected for 13% of participants. Treatment for bilateral CLP was associated with the lowest satisfaction with overall appearance (r = -8.123, P < 0.05); participants who had received orthognathic surgery had the highest satisfaction (r = 5.534, P < 0.05). Treatment for unilateral and bilateral CLP was associated with low QoL for smile (both P < 0.05). CONCLUSIONS: Orthodontic treatment had a positive effect on facial appearance and quality of life in patients with CLP. Type of cleft and orthognathic surgery significantly influenced satisfaction with facial appearance. CLINICAL RELEVANCE: Efforts must be taken to modify treatment strategies for patients with bilateral CLP in order to improve satisfaction with appearance following treatment.

One-splint versus two-splint technique in orthognathic surgery for class III asymmetry: comparison of patient-centred outcomes.

OBJECTIVES: Two-jaw orthognathic surgery (OGS) is done using either the one-splint technique with free-hand positioning of the maxillomandibular complex or the two-splint technique with intermediate splints to position the maxilla. It is uncertain which technique achieves better outcomes. This study compares frontal soft tissue symmetry and subjective patient QoL between one-splint and two-splint techniques in skeletal Class III asymmetry patients undergoing OGS with three-dimensional surgical planning. MATERIALS AND METHODS: This retrospective case-control study comprised 34 one-splint and 46 two-splint OGS patients. Frontal photographs and Orthognathic Quality of Life Questionnaire (OQLQ) were done pre- and post-treatment. Frontal soft tissue symmetry was analysed with the anthropometric Facial Symmetry Index. Measurements were compared with t-tests and chi-squared tests with p-value set at 0.05. RESULTS: The groups differed in pre-treatment ANB and OQLQ scores. The two-splint group showed significant improvement in all symmetry measures. The one-splint group showed significant improvement in all symmetry measures except midface deviation, upper contour deviation and the Facial Contour Symmetry Index. Both groups showed significant improvement in OQLQ scores. There were no significant differences in post-treatment symmetry measurements and OQLQ scores between groups. CONCLUSIONS: Although two-splint technique may better improve contour symmetry, there were no significant differences in frontal soft tissue symmetry and QoL after OGS in skeletal Class III asymmetry with either one-splint or two-splint technique, with both techniques resulting in significant improvement. CLINICAL RELEVANCE: One-splint and two-splint surgical techniques produce similar patient-centred outcomes in Class III asymmetry patients.

Comparative stability and outcomes of two surgical approaches for correction of class III asymmetry with lip or occlusal cant.

OBJECTIVES: To assess and compare the stability and outcomes of the two surgical approaches for patients with roll asymmetry. MATERIALS AND METHODS: A total of 50 adult patients were consecutively recruited for this prospective study. Patients with class III asymmetry and lip or occlusal cant who underwent bimaxillary surgery were grouped according to surgical approach: asymmetric posterior impaction on both sides (API, n = 31) and posterior impaction on one side and posterior extrusion on the other side (PIE, n = 19). Postsurgical stability and outcomes between groups were determined with cone-beam computed tomography for facial midline, lip, and occlusal cant at 1 week (T1), and at least 12-month postsurgery (T2, completion of orthodontic treatment). RESULTS: Presurgery, the upper anterior occlusal cant and lip cant were significantly greater for the PIE group (p < 0.05). Postsurgery (T2), the mandible moved upward and rotated upward in both groups. However, the upward rotation was significantly greater in the PIE group compared with the API group. Although the two approaches resulted in significant improvements in facial symmetry, the deviation in the facial midline remained under-corrected for most API patients. CONCLUSIONS: Patient outcomes for mandibular stability and facial symmetry differed between the two surgical approaches for correction of class III asymmetry with lip or occlusal cant. CLINICAL RELEVANCE: The findings of this study suggest that planned over-correction is a reasonable option for the approach of asymmetric posterior impaction on both sides.

Simultaneous Orthognathic Surgery With Asian Double Eyelid Suture Blepharoplasty.

BACKGROUND: The main objective of contemporary orthognathic surgery is to correct dentofacial deformities. Nonetheless, many adjunct procedures to enhance the esthetic outcome in orthognathic surgical cases have been successfully incorporated to improve patient satisfaction. The authors report our preliminary experience of performing simultaneous orthognathic surgery with Asian double eyelid suture method blepharoplasty in the same surgical setting. METHOD: This case series report includes all 19 consecutive cases presenting to the Chang Gung Craniofacial Center for combined orthognathic surgery with Asian double eyelid suture method blepharoplasty. The double eyelid crease height was measured as the vertical line between the upper eyelid margin (eyelid lash) and the upper eyelid crease, observed at the mid-pupillary line with the eyes in primary gaze. RESULTS: There were no complications or relapse reported within this time period. There was significant improvement in the left and right mid-pupillary double eyelid crease height postsurgery. There were no statistically significant differences between the left and right mid-pupillary double eyelid crease heights after surgery indicating good eyelid crease height symmetry bilaterally was obtained. CONCLUSIONS: Orthognathic surgery combined with suture method blepharoplasty can be safely performed in the same surgical setting without inappropriate rise in costs or operating room time. This case series demonstrates that excellent esthetic results can be obtained in simultaneous bimaxillary orthognathic surgery with suture method Asian blepharoplasty.