Conectar
by Shuang Xu, Qiongyu Zhang, Jiayan Zhou
The objective of this study was to investigate the direct effects of pain-induced depression and anxiety, as well as the mediating role of psychological resilience, on the psychological distress associated with rheumatoid arthritis. The method involved a sample of 196 patients with rheumatoid arthritis and applied the Hospital Anxiety and Depression Scale, Connor–Davidson Resilience Scale, and visual analog scale for pain. Bivariate and path analyses were performed, and a multiple mediational model was utilized. Results showed that all correlations among study variables were significant (pby Ting Zou, Xiaohui Zhou, Qinwen Wang, Yongjie Zhao, Meisheng Zhu, Lei Zhang, Wei Chen, Pari Abuliz, Haijun Miao, Keyimu Kabinur, Kader Alimu
ObjectiveTo investigate the associations of serum DNA methylation levels of chemokine signaling pathway genes with Alzheimer’s disease (AD) and mild cognitive impairment (MCI) in elderly people in Xinjiang, China, and to screen out genes whose DNA methylation could distinguish AD and MCI.
Materials and methods37 AD, 40 MCI and 80 controls were included in the present study. DNA methylation assay was done using quantitative methylation-specific polymerase chain reaction (qMSP). Genotyping was done using Sanger sequencing.
ResultsDNA methylation levels of ADCY2, MAP2K1 and AKT1 were significantly different among AD, MCI and controls. In the comparisons of each two groups, AKT1 and MAP2K1’s methylation was both significantly different between AD and MCI (p MAP2K1’s methylation was also significantly different between MCI and controls. Therefore, AKT1’s methylation was considered as the candidate serum marker to distinguish AD from MCI, and its association with AD was independent of APOE ε4 allele (p AKT1 hypermethylation was an independent risk factor for AD and MAP2K1 hypomethylation was an independent risk factor for MCI in logistic regression analysis (p Conclusion
This study found that the serum of AKT1 hypermethylation is related to AD independently of APOE ε4, which was differentially expressed in the Entorhinal Cortex of the brain and was an independent risk factor for AD. It could be used as one of the candidate serum markers to distinguish AD and MCI. Serum of MAP2K1 hypomethylation is an independent risk factor for MCI.
Sedentary behaviour is associated with a variety of adverse health outcomes, including obesity, oestrogen metabolism and chronic inflammation, all of which are related to the pathogenesis of uterine fibroids (UFs). This study aimed to explore the relationship between leisure sedentary time (LST) and UFs.
Cross-sectional.
We conducted a cross-sectional analysis of data from patients from the Yunnan region in the China Multi-Ethnic Cohort Study.
A total of 6623 non-menopausal women aged 30–55 years old were recruited. Menstrual status was self-reported. Participants who lacked a unique national identity card, suffered from serious mental illness, did not have a clear diagnosis of UFs, or provided incomplete information were excluded.
UFs were diagnosed by abdominal B-ultrasound. Leisure sedentary behaviour was assessed by using a face-to-face questionnaire interview. Logistic regression and restricted cubic spline were employed to explore the relationship between LST and UFs.
A total of 562 participants had UFs, with a prevalence rate of 8.5% (7.8%, 9.2%). Multivariate adjusted logistic regression analysis showed that the risk of UFs in women with LST≥6 hour/day was 2.008 times that in women with LST0.05). According to the results of the stratified analysis for menstrual status and body mass index (BMI), there was a correlation between LST and the prevalence of UFs only in women with a BMI2 or perimenopause.
LST was independently associated with the prevalence of UFs, and a linear dose-response relationship was observed. Our study provides evidence on the factors influencing UFs, and further research is needed to propose feasible measures for UFs prevention.
Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.
The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.
This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.
CRD42022341607.
by Yufeng Zhang, Keith D. Aaronson, Jonathan Gryak, Emily Wittrup, Cristian Minoccheri, Jessica R. Golbus, Kayvan Najarian
BackgroundTimely referral for advanced therapies (i.e., heart transplantation, left ventricular assist device) is critical for ensuring optimal outcomes for heart failure patients. Using electronic health records, our goal was to use data from a single hospitalization to develop an interpretable clinical decision-making system for predicting the need for advanced therapies at the subsequent hospitalization.
MethodsMichigan Medicine heart failure patients from 2013–2021 with a left ventricular ejection fraction ≤ 35% and at least two heart failure hospitalizations within one year were used to train an interpretable machine learning model constructed using fuzzy logic and tropical geometry. Clinical knowledge was used to initialize the model. The performance and robustness of the model were evaluated with the mean and standard deviation of the area under the receiver operating curve (AUC), the area under the precision-recall curve (AUPRC), and the F1 score of the ensemble. We inferred membership functions from the model for continuous clinical variables, extracted decision rules, and then evaluated their relative importance.
ResultsThe model was trained and validated using data from 557 heart failure hospitalizations from 300 patients, of whom 193 received advanced therapies. The mean (standard deviation) of AUC, AUPRC, and F1 scores of the proposed model initialized with clinical knowledge was 0.747 (0.080), 0.642 (0.080), and 0.569 (0.067), respectively, showing superior predictive performance or increased interpretability over other machine learning methods. The model learned critical risk factors predicting the need for advanced therapies in the subsequent hospitalization. Furthermore, our model displayed transparent rule sets composed of these critical concepts to justify the prediction.
ConclusionThese results demonstrate the ability to successfully predict the need for advanced heart failure therapies by generating transparent and accessible clinical rules although further research is needed to prospectively validate the risk factors identified by the model.
Psoriasis and chronic ulcers not only significantly impair quality of life but also pose a challenge in dermatological treatment. This study aimed to identify new therapeutic targets and biomarkers for psoriasis and chronic ulcers by comparing their gene expression profiles. The gene expression profiles of psoriatic, wound and chronic ulcer patients, as well as healthy controls, were determined via RNA extraction and next-generation sequencing of biopsies. In order to identify biomarkers, functional enrichment, differential expression analysis and machine learning algorithms were implemented. It is worth mentioning that the genes IL17A, TNF, KRT16, MMP9, and CD44 exhibited substantial correlations with the pathogenesis of the conditions being studied. As evidenced by their AUC-ROC values approaching 0.90, machine learning models accurately identified these biomarkers. The differential gene expression was consequently validated via qRT-PCR, which highlighted the increased expression of matrix remodelling enzymes and inflammatory cytokines. Additionally, genes essential for maintaining epidermis integrity and facilitating wound healing exhibited downregulation. These insights into the molecular mechanisms of psoriasis and chronic ulcers pave the way for the development of targeted therapies, offering hope for improved treatment strategies.
This meta-analysis evaluated the role of evidence-based nursing interventions in preventing pressure ulcers in patients with stroke. Computer systems were used to retrieve randomised controlled trials (RCTs) on evidence-based nursing interventions for patients with stroke and comorbid pressure ulcers from PubMed, EMBASE, Scopus, Cochrane Library, China National Knowledge Infrastructure, Chinese Biomedical Literature Database and Wanfang Data from database inception until April 2023. Two researchers independently screened the literature, extracted the data and evaluated the quality of the included studies according to the inclusion and exclusion criteria. RevMan 5.4 software was used for the meta-analysis. A total of 23 articles with results on 2035 patients were included, with 1015 patients in the evidence-based nursing group and 1020 patients in the routine nursing group. The meta-analysis results showed that evidence-based nursing interventions significantly reduced the incidence of pressure ulcers in patients with stroke (5.22% vs. 22.84%, odds ratio [OR]: 0.18, 95% confidence interval [CI]: 0.13–0.24, p < 0.001), delayed the onset of pressure ulcers (standardised mean difference [SMD]: 3.41, 95% CI: 1.40–5.42, p < 0.001) and improved patient quality of life (SMD: 2.95, 95% CI: 2.35–3.56, p < 0.001). Evidence-based nursing interventions are effective at preventing pressure ulcers in patients with stroke, delaying the onset of pressure ulcers and improving their quality of life. Evidence-based nursing should be promoted for patients with stroke. However, owing to differences in sample size between studies and the methodological inadequacies of some studies, these results should be verified by large, high-quality RCTs.
Among the assortment of available dressings aimed at promoting wound healing, moist dressings have gained significant popularity because of their ability to create an optimal environment for wound recovery. This meta-analysis seeks to compare the effects of moist dressing versus gauze dressing on wound healing time. A comprehensive literature search was conducted, encompassing publications up until April 1, 2023, across multiple databases including PubMed, Web of Science, China National Knowledge Infrastructure (CNKI), and Cochrane Library. Stringent criteria were used to determine study inclusion and evaluate methodological quality. Statistical analyses were performed utilizing Stata 17.0. A total of 13 articles, encompassing 866 participants, were included in the analysis. The findings indicate that moist dressing surpasses gauze dressing in terms of wound healing time (standard mean difference [SMD] −2.50, 95% confidence interval [CI] −3.35 to −1.66, p < 0.01; I 2 = 97.24%), wound site infection rate (odds ratio [OR] 0.30, 95% CI 0.17 to 0.54, p < 0.01; I 2 = 39.91%), dressing change times (SMD −3.65, 95% CI −5.34 to −1.97, p < 0.01; I 2 = 96.48%), and cost (SMD −2.66, 95% CI −4.24 to −1.09, p < 0.01; I 2 = 94.90%). Subgroup analyses revealed possible variations in wound healing time based on wound types and regions. This study underscores the significant advantages associated with the use of moist dressings, including expedited wound healing, reduced infection rates, decreased frequency of dressing changes, and lower overall treatment costs.
Despite the fact that machine learning (ML) algorithms to construct predictive models for pressure injury development are widely reported, the performance of the model remains unknown. The goal of the review was to systematically appraise the performance of ML models in predicting pressure injury. PubMed, Embase, Cochrane Library, Web of Science, CINAHL, Grey literature and other databases were systematically searched. Original journal papers were included which met the inclusion criteria. The methodological quality was assessed independently by two reviewers using the Prediction Model Risk of Bias Assessment Tool (PROBAST). Meta-analysis was performed with Metadisc software, with the area under the receiver operating characteristic curve, sensitivity and specificity as effect measures. Chi-squared and I 2 tests were used to assess the heterogeneity. A total of 18 studies were included for the narrative review, and 14 of them were eligible for meta-analysis. The models achieved excellent pooled AUC of 0.94, sensitivity of 0.79 (95% CI [0.78–0.80]) and specificity of 0.87 (95% CI [0.88–0.87]). Meta-regressions did not provide evidence that model performance varied by data or model types. The present findings indicate that ML models show an outstanding performance in predicting pressure injury. However, good-quality studies should be conducted to verify our results and confirm the clinical value of ML in pressure injury development.
The meta-analysis aims to evaluate and compare the impact of the combination of stem cells (SCs) and light-based treatments (LBTs) on skin wound (SW) repair. Examinations comparing SCs to LBT with SCs for SW repair was among the meta-analysis from various languages that met the inclusion criteria. Using continuous random-effect models, the results of these investigations were examined, and the mean difference (MD) with 95% confidence intervals was computed (CIs). Seven examinations from 2012 to 2022 were recruited for the current analysis including 106 animals with SWs. Photobiomodulation therapy (PBT) plus SCs had a significantly higher wound closure rate (WCR) (MD, 9.08; 95% CI, 5.55–12.61, p < 0.001) compared to SCs in animals with SWs. However, no significant difference was found between PBT plus SCs and SCs on wound tensile strength (WTS) (MD, 2.01; 95% CI, −0.42 to 4.44, p = 0.10) in animals with SWs. The examined data revealed that PBT plus SCs had a significantly higher WCR, however, no significant difference was found in WTS compared to SCs in animals with SWs. Nevertheless, caution should be exercised while interacting with its values since all the chosen examinations were found with a low sample size and a low number of examinations were found for the comparisons studied for the meta-analysis.
To find potential biomarkers based on miRNA and their potential targets in splenic monocytes in burn-injured mice. Male Balb/c mice were subjected to sham or scalding injury of 15% total body surface area. Spenic CD11b+ monocytes were purified with magnetic beads. The monocytes were cultured in the presence of lipopolysaccharide. The proliferation of monocytes was detected by MTT assay, and the cytokines in the supernatant were examined by enzyme linked immunosorbent assay. The purified monocytes were also under total RNA extraction. The differential monocytic miRNAs expression between the sham and burn-injured mice was analysed by miRNA microarray. The activity of monocytes was comparable between the two groups (p > 0.05). However, monocytes from burn-injured mice secreted higher levels of tumour necrosis factor (TNF)-α and transforming growth factor-β, but lower level of monocyte chemoattratctant protein-1. A total of 54 miRNAs were differentially expressed in monocytes from burn relative to sham-injured mice (fold >3). Further quantitative reverse transcription polymerase chain reaction confirmed that the expression of miR-146a was significantly down-regulated, while miR-3091-6p was up-regulated after burn injury. Using the combination of Miranda and TargetScan softwares, we found that mir-146a may regulate 180 potential target genes including TNF receptor related factor 6 (TRAF6), interleukin-1 receptor related kinase 1 (IRAK1) and CD28. Mir-3091-6p may regulate 39 potential targets, including SOCS7 (cytokine signal transduction inhibitor 7) and ARRB2 (arrestin, β 2). The miRNAs expressed by monocytes after burn injury may be involved in the regulation of innate immune response in burn injury.
To investigate whether human umbilical cord mesenchymal stem cell-derived exosomes combined with gelatin methacryloyl (GelMA) hydrogel are beneficial in promoting healing of laser-injured skin wounds in mice. Supernatants of cultured human umbilical cord mesenchymal stem cells (HUC-MSCs) were collected to obtain human umbilical cord MSC-derived exosomes (HUC-MSCs-Exos), which were combined with GelMA hydrogel complex to treat a mouse fractional laser injury model. The study was divided into PBS group, EX (HUC-MSCs-Exos) group, GEL (GelMA hydrogel) group and EX+GEL (HUC-MSCs-Exos combined with GelMA hydrogel) group. The healing of laser-injured skin in each group was observed by gross view and dermatoscopy, and changes in skin structure, angiogenesis and proliferation-related indexes were observed during the healing process of laser-injured skin in each group. The results of the animal experiments showed that the EX and GEL groups alone and the EL+EX group exhibited less inflammatory response compared to the PBS group. The EX and GEL groups showed marked tissue proliferation and favourable angiogenesis, which promoted the wound healing well. The GEL+EX group had the most significant promotion of wound healing compared to the PBS group. qPCR results showed that the expression levels of proliferation-related factors, including KI67 and VEGF and angiogenesis-related factor CD31, were significantly higher in the GEL+EX group than in the other groups, with a time-dependent effect. The combination of HUC-MSCs-Exos and GelMA hydrogel is beneficial in reducing the early inflammatory response of laser-injured skin in mice and promoting its proliferation and angiogenesis, which in turn promotes wound healing.
Colorectal cancer is typically treated through surgery, and self-care skills play a crucial role in disease adaptation and quality of life improvement. Therefore, this study aimed to investigate the effectiveness of a multimedia patient education intervention on enhancing the self-care and quality of life among patients with a postoperative stoma as well as on establishing an easy-to-use ostomy self-care skills assessment. The sample comprised 108 patients with new ostomies who were randomly assigned to two groups. Data were collected from June 2018 to March 2019. The conventional education service program group received individual education in the hospital environment, consisting of four 3-h sessions delivered over 4 consecutive days. The multimedia group viewed a multimedia educational program using a laptop. Data were collected at baseline and 3 months after the intervention using a demographic questionnaire, an ostomy self-care ability scale and the Stoma Quality of Life Scale. Before the intervention, there were no significant differences in self-care ability and quality of life scores between the two groups (p = 0.764 and p = 0.466, respectively). However, 3 months after the intervention, the group that received the multimedia software intervention showed significantly higher self-care ability and quality of life scores compared to the group that received conventional education services (p < 0.001). When a set threshold is reached, self-care ability and a good quality of life can be met. The threshold value of the ostomy self-care skill scale was determined to be 20 points, resulting in a sensitivity of 77.8% and a specificity of 75.5%. The results indicate that the multimedia education program enhanced home self-care ability and quality of life among patients with enterostomy.
In a meta-analysis, we assessed the impact of different surgical approaches on the outcome of hepatectomy with hepatocellular carcinoma. Four databases, including PubMed, Embase, Cochrane Library, and the Web of Science, have been critically reviewed through the full literature through June 2023. Eleven related trials were examined once they had met the trial's classification and exclusion criteria, as well as the assessment of the quality. A random effects approach was applied to analysis of operative organ infections, and a fixed-effect model was applied to determine the 95% CI and OR. Analysis of the data was done with RevMan 5.3. Our findings indicated that patients undergoing minimally invasive liver cancer surgery had significantly lower risks of surgical organ infection (OR, 0.35; 95% CI, 0.16–0.77; p = 0.009) and wound infection (OR, 0.19; 95% CI, 0.13–0.28; p < 0.001) compared to those undergoing open surgery. There was no heterogeneity observed between the two groups (I 2 = 0) in wound infection. Nevertheless, because of the limited number of randomised controlled trials in this meta-analysis, care should be taken and carefully considered in the treatment of these values. Further high-quality studies involving a large number of samples are needed to validate and reinforce the results.
A meta-analysis study was used to assess whether not placing a drain after thyroidectomy reduces postoperative wound complications. A critical review of the comprehensive literature up to May 2023 was conducted using four databases: PubMed, Embase, the Cochrane Library, and the web of science. Fourteen interrelated studies were reviewed after passing the inclusion and exclusion criteria established by the study and assessing the quality of the literature.95% confidence intervals (Cl) and odds ratios (OR) were calculated using fixed effects models. The data were meta-analysed using RevMan 5.3 software. The results showed that the use of drains during thyroid surgery did not have a favourable impact on patients. Intraoperative placement of drains did not reduce postoperative wound haematoma formation in patients, (OR, 0.86; 95% CI, 0.54, 1.36 p = 0.52). However, the incidence of postoperative wound infection was significantly higher in patients with drains used in intraoperative thyroid surgery, (OR, 0.22; 95% CI, 0.10, 0.45 p < 0.0001). As the sample size of the randomised controlled study used for this meta-analysis was limited, it is important to approach the findings with caution when interpreting the results.Conducting additional high-quality research with larger sample sizes is crucial in order to further confirm these results and reduce the likelihood of duplication.
A meta-analysis research was implemented to appraise the effect of topical antibiotics (TAs) on the prevention and management of wound infections (WIs). Inclusive literature research was performed until April 2023, and 765 interconnected researches were reviewed. The 11 selected researches included 6500 persons with uncomplicated wounds at the starting point of the research: 2724 of them were utilising TAs, 3318 were utilising placebo and 458 were utilising antiseptics. Odds ratio (OR) and 95% confidence intervals (CIs) were utilised to appraise the consequence of TAs on the prevention and management of WIs by the dichotomous approach and a fixed or random model. TAs had significantly lower WI compared with placebo (OR, 0.59; 95% CI, 0.38–0.92, p = 0.02) and compared with antiseptics (OR, 0.52; 95% CI, 0.31–0.88, p = 0.01) in persons with uncomplicated wounds (UWs). TAs had significantly lower WIs compared with placebo and antiseptics in persons with UWs. However, caution needs to be taken when interacting with their values because of the low sample size of some of the chosen researches and low number of researches found for the comparisons in the meta-analysis.
A meta-analysis was implemented to appraise the effect of hydrocolloid dressings (HCDs) in the management of different grades of pressure wound ulcers (PWUs) in critically ill adult subjects (CIUSs). Inclusive literature research until April 2023 was done, and 969 interconnected researches were revised. The 8 picked researches, enclosed 679 critically ill adult persons at the utilized researchers' starting point; 355 of them were utilizing HCDs, and 324 were controls. Odds ratio (OR) and 95% confidence intervals (CIs) were utilized to appraise the consequences of HCDs in treating CIUSs by the dichotomous approach and a fixed or random model. HCDs had significantly higher PWU complete healing (OR, 2.15; 95% CI, 1.54–3.02, p < 0.001), PWU stage II ulcers complete healing (OR, 2.82; 95% CI, 1.40–5.69, p = 0.004), and PWU stage III ulcers complete healing (OR, 3.73; 95% CI, 1.23–11.35, p = 0.02) compared to control in critically ill adult persons. HCDs had significantly higher PWU complete healing, PWU stage II ulcers complete healing, and PWU stage III ulcers complete healing compared with control in critically ill adult persons. However, caution needs to be taken when interacting with its values since there was a low sample size of most of the chosen research found for the comparisons in the meta-analysis.
The incidence of squamous cell carcinoma (SCC) is on the rise, making it a significant global health concern. Environmental risk factors are crucial to the development of SCC. This study sought to examine comprehensively the impact of these factors on the onset of SCC. We conducted a cross-sectional study involving 480 participants at Beijing tertiary care hospital. Utilizing structured questionnaires, data on demographics, environmental exposures, medical history and clinical characteristics were collected. The cohort was composed of 272 men (56.67%) and 208 women (43.33%). The majority (44.38%) were between ages of 41 and 60, and Type III skin predominated (34.79%). Most of the participants belonged to the middle socioeconomic class (60.83%). ‘Vegetarian’ dietary habits (46.67%) were prevalent, as was the ‘Sedentary’ lifestyle (49.79%). Regarding environmental exposures, moderate sun exposure of 3 to 5 h per day (54.58%) and UV protective eyewear (30.83%) were prevalent. The majority (69.58%) of respondents indicated ‘Never’ exposure to carcinogens. A variety of wound characteristics were observed, with ‘non-smokers’ (64.17%) dominating. Most SCC lesions were located on the extremities (40.21%), lasted less than 6 months (44.38%) and measured 1–3 cm (39.79%). The majority (54.58%) did not have a history of cutaneous injuries. Our research uncovered substantial relationships between SCC and numerous environmental variables, gender, Fitzpatrick skin type, occupation, duration of sun exposure, exposure to carcinogens, dietary practices, history of skin wounds, wound location, duration, size and depth were significantly associated with the onset of SCC. These results highlighted the complexity of SCC aetiology and need for individualized prevention and treatment strategies.
To compare the modified strategy for the right-sided double-lumen tube (R-DLT) placement using a combination of CT measurements and flexible video bronchoscopy guidance with traditional bronchoscopy technique.
Double-blind, parallel randomised control trial at a tertiary care medical centre in China. 100 patients undergoing video-assisted thoracoscopic surgery and requiring R-DLT were randomly allocated to the control group and the intervention group.
The control group used the traditional bronchoscopy-guided technique. In the intervention group, the length and anteroposterior diameter of the right main bronchus (RMB) were measured on CT images to select the side and size of the Rüsch tube, and then a black depth marker was placed on the tube according to the difference between the length of the RMB and the bronchial cuff. Under the guidance of bronchoscopy, the depth marker should be placed parallel to the tracheal carina and a characteristic white line on the tube should be parallel to the midline of the tracheal carina.
The primary endpoint was the positioning of right upper lobe (RUL) ventilatory slot and RUL bronchial orifice. The secondary endpoints included intubation data and perioperative adverse events.
Compared with the control group, our modified strategy significantly increased the optimal and acceptable position rate (76% vs 98%, respectively; p
This study demonstrates the superiority of our strategy and provides a new viable method for R-DLT placement.
Chinese Clinical Trial Registry (ChiCTR1900021676).
Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.
The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.
Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.
ChiCTR2000035882.
FreshRSS 