• Archives of Craniofacial Surgery
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• v.23 no.4
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• pp.152-162
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• 2022

Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.5
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• pp.339-348
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• 2022

Background: To compare the anesthetic efficacy of supplemental buccal infiltration (BI) (1.7 ml) versus intraligamentary (IL) injection containing 0.4 ml of 4% articaine with 1:100.000 epinephrine after an inferior alveolar nerve block (IANB) with 1.7 ml 2% lidocaine in the first and second mandibular molars diagnosed with irreversible pulpitis (IP). Methods: One hundred subjects diagnosed with IP of either the mandibular first (n = 50) or second molars (n = 50) and failed profound anesthesia following an IANB were selected. They randomly received either the IL or BI techniques of anesthesia. Pain scores on a 170 mm Heft-Parker visual analog scale were recorded initially, before, and during supplemental injections. Furthermore, pulse rate was measured before and after each supplemental injection. During the access cavity preparation and initial filing, no or mild pain was assumed to indicate anesthetic success. The chi-square test, Mann-Whitney U test, and independent samples t-test were used for the analyses. Results: The overall success rates were 80% in the IL group and 74% in the BI group, with no significant difference (P = 0.63). In the first molars, there was no significant difference between the two techniques (P = 0.088). In the second molars, IL injection resulted in a significantly higher success rate (P = 0.017) than BI. IL injection was statistically more successful (P = 0.034) in the second molars (92%) than in the first molars (68%). However, BI was significantly more successful (P = 0.047) in the first molars (88%) than in the second molars (64%). The mean pulse rate increase was significantly higher in the IL group than in the BI group (P < 0.001). Conclusions: Both the IL and BI techniques were advantageous when used as supplemental injections. However, more favorable outcomes were observed when the second molars received IL injection and the first molars received BI.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.4
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• pp.283-309
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• 2021

Achieving profound anesthesia in mandibular molars with irreversible pulpitis is a tedious task. This review aimed at evaluating the success of buccal/lingual infiltrations administered with a primary inferior alveolar nerve block (IANB) injection or as a supplemental injection after the failure of the primary injection in symptomatic and asymptomatic patients with irreversible pulpitis in human mandibular molars. The review question was "What will be the success of primary and supplemental infiltration injection in the endodontic treatment of patients with irreversible pulpitis in human mandibular molars?" We searched electronic databases, including Pubmed, Scopus, and Ebsco host and we did a comprehensive manual search. The review protocol was framed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist. We included clinical studies that evaluated and compared the anesthetic outcomes of primary IANB with primary and/or supplementary infiltration injections. Standard evaluation of the included studies was performed and suitable data and inferences were assessed. Twenty-six studies were included, of which 13 were selected for the meta-analysis. In the forest plot representation of the studies evaluating infiltrations, the combined risk ratio (RR) was 1.88 (95% CI: 1.49, 2.37), in favor of the secondary infiltrations with a statistical heterogeneity of 77%. The forest plot analysis for studies comparing primary IANB + infiltration versus primary IANB alone showed a low heterogeneity (0%). The included studies had similar RRs and the combined RR was 1.84 (95% CI: 1.44, 2.34). These findings suggest that supplemental infiltrations given along with a primary IANB provide a better success rate. L'Abbe plots were generated to measure the statistical heterogeneity among the studies. Trial sequential analysis suggested that the number of patients included in the analysis was adequate. Based on the qualitative and quantitative analyses, we concluded that the infiltration technique, either as a primary injection or as a supplementary injection, given after the failure of primary IANB, increases the overall anesthetic efficacy.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.3
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• pp.217-226
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• 2022

Background: Intraosseous anesthesia is the process by which an anesthetic solution, after penetration of the cortical bone, is directly injected into the spongiosa of the alveolar bone supporting the tooth. This study aimed to compare the effectiveness of the traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia in the surgical extraction of impacted lower third molars, compare their side effects systemically by monitoring heart rate, and assess patients' a posteriori preference of one technique over the other. Methods: Thirty-nine patients with bilaterally impacted third molars participated in this study. Each patient in the sample was both a case and control, where the conventional technique was randomly assigned to one side (group 1) and the alternative method to the contralateral side (group 2). Results: The traditional technique was faster in execution than anesthesia delivered via electronic syringe, which took 3 min to be administered. However, it was necessary to wait for an average of 6 ± 4 min from the execution to achieve the onset of IANB, while the latency of intraosseous anesthesia was zero. Vincent's sign and lingual nerve anesthesia occurred in 100% of cases in group 1. In group 2, Vincent's sign was recorded in 13% of cases and lingual anesthesia in four cases. The average duration of the perceived anesthetic effect was 192 ± 68 min in group 1 and 127 ± 75 min in group 2 (P < 0.001). The difference between the heart rate of group 1 and group 2 was statistically significant. During infiltration in group 1, heartbeat frequency increased by 5 ± 13 beats per minute, while in group 2, it increased by 22 ± 10 beats per minute (P < 0.001). No postoperative complications were reported for either technique. Patients showed a preference of 67% for the alternative technique and 20% for the traditional, and 13% of patients were indifferent. Conclusion: The results identified intraosseous anesthesia as a valid alternative to conventional anesthesia in impacted lower third molar extraction.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.6
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• pp.477-484
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• 2022

In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.5
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• pp.357-367
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• 2022

Background: Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children. Methods: Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 ㎍/kg for 4 min for induction, followed by maintenance of 0.4 ㎍/kg/h. Group F received an infusion of fentanyl 1 ㎍/kg over 4 min for induction, followed by maintenance at 1 ㎍/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation-Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events. Results: Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44-6.2) vs. 6.25 (4.21-7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75-21) and 22.5 (22-24) minutes, respectively (P < 0.001). The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay. Conclusion: Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.

• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.259-274
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• 2023

Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I² =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I² = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.

• Nutrition Research and Practice
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• v.17 no.2
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• pp.241-256
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• 2023

BACKGROUND/OBJECTIVES: Diabetes-specific oral nutritional supplements (ONS) have anti-hyperglycemic effects, while D-allulose exerts anti-diabetic and anti-obesity effects. In this study, we investigated the efficacy and safety of diabetes-specific ONS, including allulose, on glycemic and weight changes in overweight or obese patients with type 2 diabetes mellitus (T2DM). SUBJECTS/METHODS: A single-arm, historical-control pilot clinical trial was conducted on 26 overweight or obese patients with T2DM (age range: 30-70 yrs). The participants were administered 2 packs of diabetes-specific ONS, including allulose (200 kcal/200 mL), every morning for 8 weeks. The glycemic profiles, obesity-related parameters, and lipid profiles were assessed to evaluate the efficacy of ONS. RESULTS: After 8 weeks, fasting blood glucose (FBG) level significantly decreased from 139.00 ± 29.66 mg/dL to 126.08 ± 32.00 mg/dL (P = 0.007) and glycosylated hemoglobin (HbA1c) improved (7.23 ± 0.82% vs. 7.03 ± 0.69%, P = 0.041). Moreover, the fasting insulin (δ: -1.81 ± 3.61 μU/mL, P = 0.017) and homeostasis model assessment for insulin resistance (HOMA-IR) (δ: -0.87 ± 1.57, P = 0.009) levels decreased at 8 weeks, and body weight significantly decreased from 67.20 ± 8.29 kg to 66.43 ± 8.12 kg (P = 0.008). Body mass index (BMI) also decreased in accordance with this (from 25.59 ± 1.82 kg/m² to 25.30 ± 1.86 kg/m², P = 0.009), as did waist circumference (δ: -1.31 ± 2.04 cm, P = 0.003). CONCLUSIONS: The consumption of diabetes-specific ONS with allulose in overweight or obese patients with T2DM improved glycemic profiles, such as FBG, HbA1c, and HOMA-IR, and reduced body weight and BMI.

• The Korean Journal of Pain
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• v.36 no.1
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• pp.128-136
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• 2023

Background: The authors aimed to compare the effects of a one-time ultrasound (US)-guided subacromial corticosteroid injection and three-time ozone (O₂-O₃) injection in patients with chronic supraspinatus tendinopathy. Methods: Participants were randomly assigned to the corticosteroid group (n = 22) or ozone group (n = 22). Injections in both groups were administered into subacromial bursa with an US-guided in-plane posterolateral approach. Primary outcome measure was the change in the Western Ontario Rotator Cuff Index (WORC) score between baseline and 12-weeks post-injection. Secondary outcome measures included visual analog scale and Shoulder Pain and Disability Index scores. Assessments were recorded at baseline, and 4-weeks and 12-weeks post-injection. Results: Forty participants completed this study. Based on repeated measurement analysis of variance, a significant effect of time was found for all outcome measures in both groups. Both the groups showed clinically significant improvements in shoulder pain, quality of life, and function. Baseline, 4-week post-injection, and 12-week post-injection WORC scores (mean ± standard deviation) were 57.91 ± 18.97, 39.10 ± 20.50 and 37.22 ± 27.31 in the corticosteroid group, respectively and 69.03 ± 15.89, 39.11 ± 24.36, and 32.26 ± 24.58 in the ozone group, respectively. However, no significant group × time interaction was identified regarding all outcome measures. Conclusions: Three-time ozone injection was not superior to a one-time corticosteroid injection in patients with chronic supraspinatus tendinopathy. It might be as effective as corticosteroid injection at 4-weeks and 12-weeks post-injection in terms of relieving pain and improving quality of life and function.

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.3
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• pp.163-171
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• 2023

Background: Surgical extraction of impacted mandibular third molars is the most common procedure performed by oral surgeons. The procedure cannot be performed effectively without achieving profound anesthesia. During this procedure, patients may feel pain during surgical bone removal (at the cancellous level) or during splitting and luxation of the tooth, despite administration of routine nerve blocks. Administration of intraosseous (IO) lignocaine injections during third molar surgeries to provide effective anesthesia for pain alleviation has been documented. However, whether the anesthetic effect of lignocaine is the only reason for pain alleviation when administered intraosseously remains unclear. This conundrum motivated us to assess the efficacy of IO normal saline versus lignocaine injections during surgical removal of impacted mandibular third molars. The aim of this study was to assess the efficacy of IO normal saline as a viable alternative or adjunct to lignocaine for alleviation of intraoperative pain during surgical removal of impacted mandibular third molars. Methods: This randomized, double-blind, interventional study included 160 patients who underwent surgical extraction of impacted mandibular third molars and experienced pain during surgical removal of the buccal bone or sectioning and luxation of the tooth. The participants were divided into two groups: the study group, which included patients who would receive IO saline injections, and the control group, which included patients who would receive IO lignocaine injections. Patients were asked to complete a visual analog pain scale (VAPS) at baseline and after receiving the IO injections. Results: Of the 160 patients included in this study, 80 received IO lignocaine (control group), whereas 80 received IO saline (study group) following randomization. The baseline VAPS score of the patients and controls was 5.71 ± 1.33 and 5.68 ± 1.21, respectively. The difference between the baseline VAPS scores of the two groups was not statistically significant (P > 0.05). The difference between the numbers of patients who experienced pain relief following administration of IO lignocaine (n=74) versus saline (n=69) was not statistically significant (P > 0.05). The difference between VAPS scores measured after IO injection in both groups was not statistically significant (P >0.05) (1.05 ± 1.20 for the control group vs. 1.72 ± 1.56 for the study group) Conclusion: The study demonstrates that IO injection of normal saline is as effective as lignocaine in alleviating pain during surgical removal of impacted mandibular third molars and can be used as an effective adjunct to conventional lignocaine injection.