• Title/Summary/Keyword: Prospective randomized trial

Search Result 155, Processing Time 0.036 seconds

EFFECT OF THE CHLORHEXIDINE AND FLUORIDE-CONTAINING VARNISH ON THE LEVEL OF SALIVARY MUTANS STREPTOCOCCI (Chlorhexidine과 fluoride 성분의 varnish가 타액 내 mutans streptococci 수에 미치는 효과)

  • Seo, Jeong-Ah;Baik, Byeong-Ju;Yang, Yeon-Mi;Lee, Yong-Hee;Kim, Sang-Hoon;Kim, Jae-Gon
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.31 no.4
    • /
    • pp.579-586
    • /
    • 2004
  • The objective of the present prospective trial was to compare the efficacy of chlorhexidine(Cervitec), Fluoride (Fluorprotector) and combination of chlorhexdine and fluoride varnishes in decreasing the level of salivary mutans streptococci. Forty healthy students of school of dentistry, Chonbuk national university were investigated to evaluate mutans streptococci(MS) counts and randomized into four groups to treat with the experimental varnishes; A) untreated group(n=10), B) chlorhexidine group(n=10), C) fluoride group(n=10), D) chlorhexidine and fluoride group(n=10). Dentocult $SM^{(R)}$ (Orion Diagnostica) strip method was used for measurement of the level of mutans streptococci in saliva. Stimulated saliva were collected at baseline for mutans streptococci counts evaluation (ms1), 12 weeks later the completion of each varnish treatment, mutans streptococci counts were re-evaluated. In varnish group with chlorhexidine, fluoride and combination of chlorhexidine and fluoride, the level of mutans streptococci was lower after 12 weeks than at baseline, but there were no significant differences in saliva(p>0.05), when compared with baseline. After 12 weeks, a remarkable reduction was still found in the subjects with high level of mutans streptococci at baseline, but not different in the low and moderate level of mutans streptococci(p>0.05).

  • PDF

Effects on postoperative nausea and vomiting of nefopam versus fentanyl following bimaxillary orthognathic surgery: a prospective double-blind randomized controlled trial

  • Choi, Eunhye;Karm, Myong-Hwan;So, Eunsun;Choi, Yoon Ji;Park, Sookyung;Oh, Yul;Yun, Hye Joo;Kim, Hyun Jeong;Seo, Kwang-Suk
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.19 no.1
    • /
    • pp.55-66
    • /
    • 2019
  • Background: Postoperative nausea and vomiting (PONV) frequently occurs following bimaxillary orthognathic surgeries. Compared to opioids, Nefopam is associated with lower incidences of PONV, and does not induce gastrointestinal tract injury, coagulopathy, nephrotoxicity, or fracture healing dysfunction, which are common side effects of Nonsteroidal anti-inflammatory drugs. We compared nefopam- and fentanyl-induced incidence of PONV in patients with access to patient-controlled analgesia (PCA) following bimaxillary orthognathic surgeries. Methods: Patients undergoing bimaxillary orthognathic surgeries were randomly divided into nefopam and fentanyl groups. Nefopam 120 mg or fentanyl $700{\mu}g$ was mixed with normal saline to a final volume of 120 mL. Patients were given access to nefopam or fentanyl via PCA. Postoperative pain intensity and PONV were measured at 30 minutes and 1 hour after surgery in the recovery room and at 8, 24, 48, and 72 hours after surgery in the ward. The frequency of bolus delivery was compared at each time point. Results: Eighty-nine patients were enrolled in this study, with 48 in the nefopam (N) group and 41 in the fentanyl (F) group. PONV occurred in 13 patients (27.7%) in the N group and 7 patients (17.1%) in the F group at 8 hours post-surgery (P = 0.568), and there were no significant differences between the two groups at any of the time points. VAS scores were $4.4{\pm}2.0$ and $3.7{\pm}1.9$ in the N and F groups, respectively, at 8 hours after surgery (P = 0.122), and cumulative bolus delivery was $10.7{\pm}13.7$ and $8.6{\pm}8.5$, respectively (P = 0.408). There were no significant differences in pain or bolus delivery at any of the remaining time points. Conclusion: Patients who underwent bimaxillary orthognathic surgery and were given nefopam via PCA did not experience a lower rate of PONV compared to those that received fentanyl via PCA. Furthermore, nefopam and fentanyl did not provide significantly different postoperative pain control.

Anesthetic efficacy of supplemental buccal infiltration versus intraligamentary injection in mandibular first and second molars with irreversible pulpitis: a prospective randomized clinical trial

  • Zargar, Nazanin;Shojaeian, Shiva;Vatankhah, Mohammadreza;Heidaryan, Shirin;Ashraf, Hengameh;Baghban, Alireza Akbarzadeh;Dianat, Omid
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.22 no.5
    • /
    • pp.339-348
    • /
    • 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.

The Present Clinical Studies of Oriental Medicine and CAM Therapies in Chemotherapy-induced Peripheral Neurotoxicity (항암제 유발 신경독성을 관리하는 한의학 및 보완대체요법들과 임상시험 현황)

  • Park, Sun-Ju;Go, Ho-Yeon;Han, Yoo-Jin;Ko, Seong-Gyu;Kim, Sung-Hoon
    • The Korea Journal of Herbology
    • /
    • v.24 no.4
    • /
    • pp.205-213
    • /
    • 2009
  • Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

Incidence of postoperative pain after using single continuous, single reciprocating, and full sequence continuous rotary file system: a prospective randomized clinical trial

  • Umesh Kumar;Pragnesh Parmar;Ruchi Vashisht;Namita Tandon;Charan Kamal Kaur
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.23 no.2
    • /
    • pp.91-99
    • /
    • 2023
  • Background: Extrusion of debris is a major factor that results in postoperative pain during root canal treatment with various instruments and instrumentation techniques. Therefore, instrumentation techniques that extrude minimal debris into the periapical area while reducing pain are desirable. This study aimed to compare the incidence of postoperative pain and intake of analgesic medication (frequency and quantity) after endodontic treatment of mandibular posterior teeth using two single files and full-sequence continuous rotary systems with different kinematic motions. Methods: Thirty-five of 105 patients were assigned equally to three groups according to the instrumentation system used: ProTaper Next (PN) X2, 25/06 (Dentsply, Maillefer, Ballaigues, Switzerland), One Shape (OS), #0.25/06 (Micro Mega, Besancon, France), and Wave One Gold (WG), Red - #0.25, 0.07 (Dentsply, Maillefer, Ballaigues, Switzerland). Five specialists were included in this study design; each professional prepared 21 teeth, and randomly selected 7 per instrument system. The VAS sheet ranging from 0 to 10 was used to record the initial and postoperative pains at 24, 48, and 72 h, and 7th day after single visit endodontic treatment in mandibular premolars and molars with a diagnosis of asymptomatic irreversible pulpitis with or without apical periodontitis. Postoperatively, an analgesic, ibuprofen 400 mg was administered for intolerable pain at a dose of 1 tablet for 6 h. The patients were asked over the telephone regarding postoperative pain at intervals of 24, 48, and 72 h, and 7th day using a visual analogue scale. Result: There were no statistically significant differences among the PN, OS, and WG systems (P > 0.05) with regard to the incidence of postoperative pain at any of the four time points assessed. Conclusion: The intensity of postoperative pain, frequency, and analgesic intake were similar across all three types of instrument systems; however, the reciprocating single file (WG) was associated with less postoperative pain than the full sequence continuous rotary file.

Randomized Trial of Early Versus Late Alternating Radiotherapy/ Chemotherapy in Limited-Disease Patients with Small Cell Lung Cancer (국한성병기 소세포폐암 환자에서 조기 혹은 지연 교대 방사선-항암제치료의 전향적 비교연구)

  • Lee Chang Geol;Kim Joo Hang;Kim Sung Kyu;Kim Sei Kyu;Kim Gwi Eon;Suh Chang Ok
    • Radiation Oncology Journal
    • /
    • v.20 no.2
    • /
    • pp.116-122
    • /
    • 2002
  • Purpose : A randomized prospective study was conducted to compare the efficacy of early or late alternating schedules of radiotherapy, and carboplatin and ifosfamide chemotherapy in patients with limited-disease small cell lung cancer. Materials and Methods: From August 1993 to August 1996, a total of 44 patients with newly diagnosed, limited-disease small cell lung cancer, PS $H0\~2$, wt $loss<10\%$ were enrolled in a randomized trial which compared early alternating radiotherapy (RT)/chemotherapy (CT) and late alternating RT/CT. The CT regimen included ifosfamide $1.5\;g/m^2$ IV, d1-5 and carboplatin AUC 5/d IV, d2 peformed at 4 week intervals for a total of 6 cycles. RT (54 Gy/30 fr) was started after the first cycle of CT (early arm, N=22) or after the third cycle of CT (late arm, N=22) with a split course of treatment. Results : The pretreatment characteristics between the two arms were well balanced. The response rates in the early $(86\%)$ and late $(85\%)$ arm were similar. The median survival durations and 2-year survival rates were 15 months and $22.7\%$ in the early arm, and 17 months and $14.9\%$ in the late arm (p=0.47 by the log-rank test). The two-year progression free survival rates were $19.1\%$ in the early arm and $19.6\%$ in the late arm (p=0.52 by the log-rank test). Acute grade 3 or 4 hematologic and nonhematologic toxicities were similar between the two arms. Eighteen patients $(82\%)$ completed 6 cycles of CT in the early arm and 17 $(77\%)$ in the late arm. Four patients received less than 45 Gy of RT in the early arm and two in the late arm. There was no significant difference in the failure patterns. The local failure rate was $43\%$ in the early arm and $45\%$ in the late arm. The first site of failure was the brain in $24\%$ of the early arm patients compared to $35\%$ in the late arm (p=0.51). Conclusion : There were no statistical differences in the overall survival rate and the pattern of failure between the early and late alternating RT/CT in patients with limited-disease small cell lung cancer.

A Prospective Randomized Trial Comparing the Seciuence of Adiuvant Chemotherapy and Radiotherapy following Curative Resection of Stage II, III Rectal Cancer (직장암의 근치적 수술 루 방사선치료와 화학요법의 순서에 대한 고찰 -전향적 무작위 3상 임상연구 중간 결과 보고-)

  • Kim Kyoung Ju;Kim Jong Hoon;Choi Eun Kyung;Chang Hyesook;Ahn Seung Do;Lee Je Hwan;Kim Jin Cheon;Yu Chang Sik
    • Radiation Oncology Journal
    • /
    • v.18 no.1
    • /
    • pp.17-25
    • /
    • 2000
  • Purpose : To evaluate the side effects, pattern of failure, and survival rate according to the sequence of postoperative adjuvant radiotherapy and chemotherapy, patients with stages II and III rectal cancer who had undergone curative resection were randomized to 'early radiotherapy group (arm I)' or' late radiotherapy group (arm II)', then we intend to determine the most effective sequence of the radiotherapy and chemotherapy. Materials and Methods . From January 1996 to March 1999, 313 patients with curatively resected stages II and III rectal cancer have been randomized to' early' or' late' radiation therapy group and received combined chemotherapy (5-FU 375 mg/m$^{2}$/day, ieucovorin 20 mg/m$^{2}$, IV bolus daily Dl-5, 8 cycles) and radiation therapy (whole pelvis with 45 Gy/25 fractions/s weeks). Arm I received radiation therapy from day 1 with first cycle of chemotherapy and arm II received radiation therapy from day 57 with third cycle of chemotherapy after completion of first two cycles. Preliminary analysis was peformed with 228 patients registered up to Jun 1998. Two out of the 228 patients were excluded because of double primary cancer. Median follow-up period was 23 months. Results :Local recurrence occurred in 11 patients (9.7$\%$) for arm I and 9 patients (8$\%$) for arm 11. There was no significant difference between both groups ( p=0.64). However, distant metastasis was found in 22 patients (19.5$\%$) for arm I and 35 patients (31.0$\%$) for arm II and which showed statistically significant difference between the two groups ( p=0.046). And neither 3-year disease-free survival (70.2$\%$ vs 59.2$\%$, p=0.2) nor overall survival (89.4$\%$ vs 88.0$\%$, p=0.47) showed significant differences. The incidence of leukopenia during radiation therapy and chemotherapy was 78.3$\%$ and 79.9$\%$ respectively but leukopenia more than RTOG grade 3 was only 2.1$\%$ and 6.0$\%$ respectively. The incidence of diarrhea more than 10 times per day was significantly higher in the patients for arm I than for arm II (71.2$\%$ vs 41.6$\%$, p=0.02) but this complication was controlled with supportive cares. Conclusion : Regardless of the sequence of postoperative adjuvant radiation therapy and chemotherapy after curative resection for rectal cancer, local recurrence rate was low with combined chemoradlotherapy. But distant metastasis rate was lower in early radiation therapy group than in late radiation therapy group and the reason is unclear. Most patients completed these treatments without severe complication, so these were thought to be safe treatments but the treatment compliance should be improved.

  • PDF

Nonpharmacologic Pain Relief with Oral 25% Dextrose or/and Pacifier for Newborn Infants (신생아에서 비약물적 통증조절을 위한 25% 경구 포도당과 인공 젖꼭지 사용의 효과)

  • Kim, Min-Kyung;Kim, In-Ah;Jung, Min-Hee;Han, Myung-Ki;Park, Kie-Young;Kim, Bong-Seong;Jin, Hyun-Seong
    • Neonatal Medicine
    • /
    • v.18 no.2
    • /
    • pp.353-358
    • /
    • 2011
  • Purpose: The goal of this study was to compare the efficacy of oral 25% dextrose treatment or/and pacifier for analgesia in healthy newborns during intramuscular injection of a hepatitis B vaccine. Methods: A prospective, randomized, partially blinded, clinical trial was performed in 132 healthy newborns. They were assigned randomly to 4 treatment groups: control group (2 mL distilled water), dextrose group (2 mL 25% dextrose), pacifier group, dextrose+pacifier group (pacifier coating with 25% dextrose) during intramuscular injection of hepatitis B vaccine. For all groups, Neonatal Infant Pain Scale (NIPS), Neonatal Facial Coding System (NFCS), Premature Infant Pain Profile (PIPP) scores were evaluated before the injection, during the injection, and at 2 minutes after the injection. Pain scores were compared among the 4 groups. Results: Maternal and neonatal characteristics were similar among the 4 groups. 25% dextrose treatment led to lower NIPS pain scores during injection (6.4${\pm}$0.9 vs. 5.5${\pm}$1.7, P=0.01) and after injection (1.6${\pm}$2.0 vs. 0.6${\pm}$0.9, P=0.01) and NFCS pain scores after injection (1.5${\pm}$2.3 vs. 0.7${\pm}$0.8, P=0.04) than control group. The number of neonates who feel the pain (indication of scores: NIPS${\geq}$4, NFCS${\geq}$3) decreased (9 (23.1%) vs. 0 (0%), P=0.04 via NIPS, 7 (17.9%) vs. 0 (0%), P=0.02 via NFCS). However, all treatment groups did not decreased PIPP scores, compared with the control group. Conclusion: Oral 25% dextrose is effective than distilled water or using pacifier with or without 25% dextrose in reducing pain during intramuscular injection of hepatitis B vaccinations. Further study based on this preliminary study need about nonpharmacologic management of pain in newborns.

Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.33 no.3
    • /
    • pp.159-170
    • /
    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.

Accelerated Fractionation In The Treatment of Brain Metastasis From Non-Small Cell Carcinoma of The Lung (비소세포성 폐암환자의 뇌전이에 대한 급속분할조사법)

  • Hong, Seong-Eon
    • Radiation Oncology Journal
    • /
    • v.12 no.2
    • /
    • pp.165-173
    • /
    • 1994
  • Purpose : Metastatic cancer to the brain is a major problem for the patients with bronchogenic carcinoma, and most of these patients have a limited survival expectancy. To increase tumor control and / or to decrease late morbidity with possible shortening in over-all treatment period, multiple daily fraction technique for brain metastasis was performed. The author reperesented the results of accelerated fractionation radiotherapy in patients with brain metastases from non-small cell lung cancer. Materals and Methods : Twenty-six patients with brain metastases from non-small cell lung cancer between 1991 and 1993 received brain radiotherapy with a total dose of 48 Gy, at 2 Gy per fraction, twice a day with a interfractional period of 6 hours, and delivered 5 days a week. The whole brain was treated to 40 Gy and boost dose escalated to 8 Gy for single metastatic lesion by reduced field. Twenty-four of the 26 patients completed the radiotherapy. Radiotherapy was interupted in two patients suggesting progressive intracerebral diseases. Results : This radiotherapy regimen appears to be comparable to the conventional scheme in relief from symptoms. Three of the 24 patients experienced nausea and or vomiting during the course of treatment because of acute irradiation toxicity. The author observed no excessive toxicity with escalating dose of irradiation. An increment in median survival, although not statistically significant(p>0.05), was noted with escalating doses(48 Gy) of accelerated fractionation(7 months) compared to conventional treatment(4.5 months). Median survival also increased in patients with brain solitary metastasis(9 months) compared to multiple extrathoracic sites(4 months), and in patients with good performance status(9 months versus 3.5 months), they were statistically significant (p<0.01). Conclusion : The increment in survival in patients with good prognostic factors such as controlled primary lesion, metastasis in brain only and good perfomance status appeared encouraging. Based on these results, a multi-institutional prospective randomized trial should be initiated to compare the twice-a-day and once-a-day radiotherapy schemes on patients with brain metastasis with careful consideration for the patients' quality of life.

  • PDF