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European Journal of Dentistry May 2024This article reappraises the accuracy and factors associated with the detection of the cementoenamel junction (CEJ) using the tactile method.
OBJECTIVES
This article reappraises the accuracy and factors associated with the detection of the cementoenamel junction (CEJ) using the tactile method.
MATERIALS AND METHODS
A total of 111 tooth sites of 7 patients scheduled for flap surgery were selected for the study. The CEJ was detected in a blind manner using the conventional tactile method with a standard periodontal probe by a single, trained examiner. A custom-made stent was prepared to standardize the measurements and the distance from a fixed reference point on the stent to the CEJ was measured before (apparent CEJ) and after (real CEJ) opening a gingival flap. To evaluate the effect of local anesthesia (LA) on the measurement error, assessment with and without LA given prior to the measurement was also evaluated. The bone crest-CEJ distance at each site was also recorded in all sites.
STATISTICAL ANALYSIS
The measurement error of apparent versus real distance, if any, was compared using Cohen's weighted kappa coefficient (WKC) (± 1 mm).
RESULTS
A weak WKC (WKC = 0.539) was found between the apparent and real CEJ distance. Higher WKCs were noted at posterior and proximal sites than the anterior and buccal/lingual sites, respectively (0.840 and 0.545 vs. 0.475 and 0.488). A higher confluence of the agreements was noted when CEJ distance was measured in anesthetized sites (WKC = 0.703). Sites without bone loss showed more coronal deviation of CEJ detection, as opposed to apical deviation seen at sites with bone loss.
CONCLUSION
The conventional CEJ detection using the tactile method was relatively imprecise depending on the anatomical location of the tooth and the bone loss at the site of measurement. However, the detection accuracy improved when the sites were anesthetized. In clinical terms, our data, reported here for the first time imply that, in the absence of visual cues, posterior tooth site measurements of periodontal attachment loss were more reliable in comparison to the other sites. The bone crest level also impacted the measurement deviation to some extent, implying that, possible overestimate of clinical attachment loss may occur at sites without bone loss.
PubMed: 38759998
DOI: 10.1055/s-0044-1786865 -
Translational Vision Science &... May 2024To evaluate the visual performance in adolescents undergoing orthokeratology (OrthoK) treatment with two different optical zone diameters (OZDs). (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To evaluate the visual performance in adolescents undergoing orthokeratology (OrthoK) treatment with two different optical zone diameters (OZDs).
METHODS
This randomized, double-masked, self-controlled prospective study was conducted at Tianjin Eye Hospital (Tianjin, China) in June 2022. Thirty-six eligible schoolchildren were enrolled and fitted with corneal refractive therapy lenses with two sizes of OZDs (5 mm [5OZ] and 6 mm [6OZ]). Each participant was randomized to wear the 5OZ in one eye and the 6OZ in the contralateral eye. Subjective visual quality was assessed using visual acuity, refraction, contrast sensitivity function, and visual symptoms, and the objective optical quality was assessed using ocular higher order aberrations (HOAs) and modulation transfer function (MTF).
RESULTS
Thirty-five myopic children completed a 1-month follow-up visit. The 5OZ lens induced significantly smaller treatment zone diameters than the 6OZ lens (P < 0.001). Subjective visual quality did not differ significantly between the two groups. Compared to baseline, aberrations of Z40, coma-like, spherical-like, and total HOAs in both groups increased significantly (P < 0.05). For the 3-mm pupils, spherical aberration in the 5OZ group was significantly higher than that in the 6OZ group (P < 0.05). The MTF value of the 6OZ group was significantly higher than that of 5OZ group for 0.3 and 1.5 cycles per degree for the 3-mm pupils (P = 0.006 and P = 0.026, respectively). However, HOAs or MTF did not differ significantly between the two groups for the 5-mm pupils.
CONCLUSIONS
The difference induced by varying OZD was significant only in the smaller pupil condition. The selection of OZD in OrthoK designs in real-world patient management should be done while considering individual pupil size.
TRANSLATIONAL RELEVANCE
This study revealed that the objective visual quality of small OZD lenses was only slightly affected for the small pupil size.
Topics: Humans; Female; Orthokeratologic Procedures; Male; Visual Acuity; Prospective Studies; Adolescent; Myopia; Child; Double-Blind Method; Refraction, Ocular; Contrast Sensitivity; Contact Lenses
PubMed: 38758570
DOI: 10.1167/tvst.13.5.12 -
Journal of Psychosomatic Obstetrics and... Dec 2024
Statement of Retraction: Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.
PubMed: 38758364
DOI: 10.1080/0167482X.2024.2346385 -
Anesthesiology May 2024Preventing emergence delirium is a clinical goal for pediatric anesthesia, yet there is no consensus on its prevention. This study investigated the hypothesis that a...
BACKGROUND
Preventing emergence delirium is a clinical goal for pediatric anesthesia, yet there is no consensus on its prevention. This study investigated the hypothesis that a continuous infusion or a single bolus of remimazolam can reduce the incidence of emergence delirium in children.
METHODS
A hundred and twenty children aged 1-6 years old were randomly and equally allocated into three groups: group RC, which received a continuous infusion of remimazolam at 1 mg kg -1 h -1; group RB, which received a single bolus of remimazolam at 0.2 mg kg -1 at the beginning of wound closure; and group C, which received a continuous infusion of saline at 1 mL kg -1 h -1 and single bolus of saline at 0.2 mL kg -1 at the beginning of sutures. The primary outcome was the incidence of emergence delirium assessed by pediatric anesthesia emergence delirium (PAED) scale. Secondary outcomes included the number of rescues propofol administrations in the post-anesthesia care unit (PACU), recovery time, end-tidal sevoflurane concentration when maintaining BIS within the range of 40-60, and adverse events.
RESULTS
The incidence of emergence delirium in group RC (5%, vs. group C, risk ratio, 0.14; 95% CI, 0.04 to 0.59; P=0.001) and group RB (7.7%, vs. group C, risk ratio, 0.22; 95% CI, 0.07 to 0.71; P=0.003) was significantly lower compared with group C (32.5%). Propofol was given to 2 patients in each of groups RC and RB to treat delirium and to 10 patients in group C (group RC vs. group C, risk ratio, 0.20; 95% CI, 0.05 to 0.86; P=0.012; group RB vs. group C, risk ratio, 0.21; 95% CI, 0.05 to 0.88; P=0.014). No differences in the recovery time and adverse effects were detected.
CONCLUSIONS
Both continuous infusion and single bolus administration of remimazolam can effectively reduce the occurrence of emergence delirium in children.
PubMed: 38758221
DOI: 10.1097/ALN.0000000000005077 -
Frontiers in Psychiatry 2024Anorexia nervosa (AN) is a life-threatening disease with a low effectiveness of treatment. The high relapse and mortality rate indicate new treatment approaches are...
BACKGROUND
Anorexia nervosa (AN) is a life-threatening disease with a low effectiveness of treatment. The high relapse and mortality rate indicate new treatment approaches are needed. Here, we represent the protocol for randomized clinical trial (RCT) of transcranial direct current stimulation (tDCS) efficiency in the AN treatment. The main purpose of the 3-week RCT is to determine the effect of tDCS on the mental state and advances in nutritional rehabilitation in patients with AN.
METHODS
50 female inpatients (13-25 years old, body mass index (BMI) 17.5 kg/m2 or less) will be randomly allocated into groups: active (n=25) and sham (n=25) tDCS. Thirty 25-minute tDCS sessions (applied current at 2mA) will be given to DLPFC (F3 anode/F4 cathode) twice a day for 3 weeks on working days parallel to treatment as usual. The primary outcome measures include changes in symptoms related to eating disorders, as assessed by the Eating Attitudes Test (EAT-26), following tDCS sessions over a 3-week trial period. The secondary outcome measures include changes in: brain bioelectric activity, anthropometric measurements, mood, nutritional status, neurocognition, psychological symptoms, selected biological markers related to stress, food intake, inflammation and neurotrophins.
DISCUSSION
This paper describes the evaluation of a 3-week tDCS-based intervention for AN patients. The study design was developed by a multidisciplinary research team to assess the treatment effect, taking into account various types of variables. This approach could help in better understanding the potential therapeutic tDCS strategy in AN.
CLINICAL TRIAL REGISTRATION
www.ClinicalTrials.gov, identifier NCT05814458.
PubMed: 38757134
DOI: 10.3389/fpsyt.2024.1284675 -
Frontiers in Nutrition 2024Pycnogenol French maritime pine bark extract is a well-known and thoroughly studied patented extract from the bark of . In 39 randomized double-blind, placebo-controlled... (Review)
Review
Pycnogenol French maritime pine bark extract is a well-known and thoroughly studied patented extract from the bark of . In 39 randomized double-blind, placebo-controlled (RDP) human clinical trials including 2,009 subjects, Pycnogenol French maritime pine bark extract supplementation for two weeks to six months has been shown to beneficially affect cardiovascular health, chronic venous insufficiency, cognition, joint health, skin health, eye health, women's health, respiratory health and allergies, oral health and sports performance. The mechanisms of action that can explain the respective effects on different conditions in the human body are discussed as well. As investigated in several , and in clinical studies, Pycnogenol French maritime pine bark extract showed antioxidative effects, anti-inflammatory abilities, beneficial effects on endothelial function and reinforcing effects on the extracellular matrix. The present review aims to give a comprehensive overview of currently available "gold standard" RDP trials of Pycnogenol's benefits across various health domains compared to placebo. In addition, some of the processes on which the presented effects of Pycnogenol French maritime pine bark extract are based will be elucidated and discussed. This broad overview of RDP studies on Pycnogenol in different health domains can be used as a basis for further research on applications and mechanisms of this unique French maritime pine bark extract.
PubMed: 38757130
DOI: 10.3389/fnut.2024.1389374 -
Frontiers in Nutrition 2024The present double-blinded randomized clinical trial aimed to investigate the effect of selenium supplementation on oxidative stress, clinical, and physiological...
BACKGROUND AND AIM
The present double-blinded randomized clinical trial aimed to investigate the effect of selenium supplementation on oxidative stress, clinical, and physiological symptoms in patients with migraine.
METHODS
In total, 72 patients with migraine were randomly assigned to receive either 200 μg/day selenium ( = 36) or placebo ( = 36) for 12 weeks. Clinical traits of migraine (e.g., severity, frequency, and duration of headaches), mental health indices (e.g., depression, anxiety, and distress), quality of life, biomarkers of oxidative stress (e.g., nitric oxide [NO], malondialdehyde [MDA], total antioxidant capacity [TAC], total oxidant status [TOS]), and anthropometric indices were assessed at baseline and at the end of the study.
RESULTS
Selenium supplementation resulted in a significant reduction in NO (-1.24 ± 0.43 vs. 0.16 ± 0.43; = 0.03) levels and a significant increase in TAC (9.89 ± 2.50 vs. -0.18 ± 2.50; = 0.01) compared to the placebo group. Moreover, selenium supplementation had a significant protective effect against MDA levels compared to placebo (0.33 ± 0.57 vs. 1.83 ± 0.57; = 0.03). In addition, selenium intake was associated with a lower headache frequency (-8.15 ± 0.77 vs. -4.12 ± 0.77; < 0.001) and severity (-2.89 ± 0.42 vs. -1.16 ± 0.42; = 0.01) as well as a lower Headache Impact Test-6 (HIT-6) score (-9.22 ± 2.00 vs. -2.08 ± 2.00; = 0.02) compared to the controls. For other outcome variables, we found no significant effect.
CONCLUSION
Selenium supplement may be considered a complementary therapy in patients with migraine due to its beneficial effects on oxidative stress and migraine symptoms. Further studies are needed to affirm our findings.: This study was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir) on 27 May 2023 with code number of IRCT20121216011763N60.
PubMed: 38757125
DOI: 10.3389/fnut.2024.1369373 -
Multiple Sclerosis Journal -... 2024Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for four consecutive weeks, increased...
Low-intensity repetitive transcranial magnetic stimulation is safe and well tolerated by people living with MS - outcomes of the phase I randomised controlled trial (TAURUS).
BACKGROUND
Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for four consecutive weeks, increased the number of new oligodendrocytes in the adult mouse brain. Therefore, rTMS holds potential as a remyelinating intervention for people with multiple sclerosis (MS).
OBJECTIVE
Primarily to determine the safety and tolerability of our rTMS protocol in people with MS. Secondary objectives include feasibility, blinding and an exploration of changes in magnetic resonance imaging (MRI) metrics, patient-reported outcome measures (PROMs) and cognitive or motor performance.
METHODS
A randomised (2:1), placebo controlled, single blind, parallel group, phase 1 trial of 20 rTMS sessions (600 iTBS pulses per hemisphere; 25% maximum stimulator output), delivered over 4-5 weeks. Twenty participants were randomly assigned to 'sham' ( = 7) or active rTMS ( = 13), with the coil positioned at 90° or 0°, respectively.
RESULTS
Five adverse events (AEs) including one serious AE reported. None were related to treatment. Protocol compliance was high (85%) and blinding successful. Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time.
CONCLUSION
Twenty sessions of rTMS is safe and well tolerated in a small group of people with MS. The study protocol and procedures are feasible. Improvement of sham is warranted before further investigating safety and efficacy.
PubMed: 38756414
DOI: 10.1177/20552173241252571 -
Frontiers in Bioengineering and... 2024Glaucoma, the leading cause of irreversible blindness globally, affects more than 70 million people across the world. When initial treatments prove ineffective,...
Glaucoma, the leading cause of irreversible blindness globally, affects more than 70 million people across the world. When initial treatments prove ineffective, especially for cases with high intraocular pressure (IOP), the preferred approach involves employing glaucoma drainage devices (GDDs). This study introduces a novel self-adjustable glaucoma drainage device (SAGDD) designed to maintain IOP within the desired biological range (10 mmHg < IOP <18 mmHg) by dynamically modulating its fluidic resistance. Inspired by the starling resistor, we designed a circular valve with a thin, flexible membrane placed over the valve's inlet and outlet. To achieve the ideal design for the SAGDD and optimize its parameters, we utilized fluid-solid interaction (FSI) numerical models and conducted parametric studies, wherein simulations demonstrated the validity of the concept. Subsequently, to confirm and validate the numerical results, we fabricated a SAGDD at a 3:1 scale and subjected it to testing. Our findings demonstrate that, on a 3:1 scale, a circular SAGDD with a diameter of 8.1 mm and a stainless-steel membrane with a thickness of 10 µm effectively maintained IOP within the target range when the membrane exposed to external pressures of 7.5 or 10 mmHg. In summary, our study establishes a strong foundation for further exploration of the potential efficacy of SAGDD as a promising treatment for glaucoma. The cost-effectiveness and simplicity of its design, devoid of costly instrumentation, hold considerable promise in addressing the challenges associated with glaucoma.
PubMed: 38756411
DOI: 10.3389/fbioe.2024.1383459 -
EClinicalMedicine Jun 2024Previous trials of renal denervation (RDN) have been designed to investigate reduction of blood pressure (BP) as the primary efficacy endpoint using non-selective RDN...
BACKGROUND
Previous trials of renal denervation (RDN) have been designed to investigate reduction of blood pressure (BP) as the primary efficacy endpoint using non-selective RDN without intraoperatively verified RDN success. It is an unmet clinical need to map renal nerves, selectively denervate renal sympathetic nerves, provide readouts for the interventionalists and avoid futile RDN. We aimed to examine the safety and efficacy of renal nerve mapping/selective renal denervation (msRDN) in patients with uncontrolled hypertension (HTN) and determine whether antihypertensive drug burden is reduced while office systolic BP (OSBP) is controlled to target level (<140 mmHg).
METHODS
We conducted a randomized, prospective, multicenter, single-blinded, sham-controlled trial. The study combined two efficacy endpoints at 6 months as primary outcomes: The control rate of patients with OSBP <140 mmHg (non-inferior outcome) and change in the composite index of antihypertensive drugs (Drug Index) in the treatment versus Sham group (superior outcome). This design avoids confounding from excess drug-taking in the Sham group. Antihypertensive drug burden was assessed by a composite index constructed as: Class N (number of classes of antihypertensive drugs) × (sum of doses). 15 hospitals in China participated in the study and 220 patients were enrolled in a 1:1 ratio (msRDN vs Sham). The key inclusion criteria included: age (18-65 years old), history of essential HTN (at least 6 months), heart rate (≥70 bpm), OSBP (≥150 mmHg and ≤180 mmHg), ambulatory BP monitoring (ABPM, 24-h SBP ≥130 mmHg or daytime SBP ≥135 mmHg or nighttime SBP ≥120 mmHg), renal artery stenosis (<50%) and renal function (eGFR >45 mL/min/1.73 m). The catheter with both stimulation and ablation functions was inserted in the distal renal main artery. The RDN site (hot spot) was selected if SBP increased (≥5 mmHg) by intra-renal artery (RA) electrical stimulation; an adequate RDN was confirmed by repeated electronic stimulation if no increase in BP otherwise, a 2nd ablation was performed at the same site. At sites where there was decreased SBP (≥5 mmHg, cold spot) or no BP response (neutral spot) to stimulation, no ablation was performed. The mapping, ablation and confirmation procedure was repeated until the entire renal main artery had been tested then either treated or avoided. After msRDN, patients had to follow a predefined, vigorous drug titration regimen in order to achieve target OSBP (<140 mmHg). Drug adherence was monitored by liquid chromatography-tandem mass spectrometry analysis using urine. This study is registered with ClinicalTrials.gov (NCT02761811) and 5-year follow-up is ongoing.
FINDINGS
Between July 8, 2016 and February 23, 2022, 611 patients were consented, 220 patients were enrolled in the study who received standardized antihypertensive drug treatments (at least two drugs) for at least 28 days, presented OSBP ≥150 mmHg and ≤180 mmHg and met all inclusion and exclusion criteria. In left RA and right RA, mapped sites were 8.2 (3.0) and 8.0 (2.7), hot/ablated sites were 3.7 (1.4) and 4.0 (1.6), cold spots were 2.4 (2.6) and 2.0 (2.2), neutral spots were 2.0 (2.1) and 2.0 (2.1), respectively. Hot, cold and neutral spots was 48.0%, 27.5% and 24.4% of total mapped sites, respectively. At 6 M, the Control Rate of OSBP was comparable between msRDN and Sham group (95.4% vs 92.8%, p = 0.429), achieved non-inferiority margin -10% (2.69%; 95% CI -4.11%, 9.83%, p < 0.001 for non-inferiority); the change in Drug Index was significantly lower in msRDN group compared to Sham group (4.37 (6.65) vs 7.61 (10.31), p = 0.010) and superior to Sham group (-3.25; 95% CI -5.56, -0.94, p = 0.003), indicating msRDN patients need significantly fewer drugs to control OSBP <140 mmHg. 24-hour ambulatory SBP decreased from 146.8 (13.9) mmHg by 10.8 (14.1) mmHg, and from 149.8 (12.8) mmHg by 10.0 (14.0) mmHg in msRDN and Sham groups, respectively (p < 0.001 from Baseline; p > 0.05 between groups). Safety profiles were comparable between msRDN and Sham groups, demonstrating the safety and efficacy of renal mapping/selective RDN to treat uncontrolled HTN.
INTERPRETATION
The msRDN therapy achieved the goals of reducing the drug burden of HTN patients and controlling OSBP <140 mmHg, with only approximately four targeted ablations per renal main artery, much lower than in previous trials.
FUNDING
SyMap Medical (Suzhou), LTD, Suzhou, China.
PubMed: 38756107
DOI: 10.1016/j.eclinm.2024.102626