scholarly journals A multicenter randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 2: Pain perception

2015 ◽  
Vol 86 (1) ◽  
pp. 149-156 ◽  
Author(s):  
Shahla Rahman ◽  
R. James Spencer ◽  
Simon J. Littlewood ◽  
Lian O'Dywer ◽  
Sophy K. Barber ◽  
...  
Keyword(s):  
Pain Perception ◽  
Soft Tissues ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Pain Experience ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Clinically Significant

ABSTRACT Objective:  To compare pain experience between self-ligating and conventional preadjusted edgewise appliance systems with a two-arm parallel trial. Materials and Methods:  A prospective multicenter randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip™) or conventional (3M Victory™) bracket system with stratification for operator and center. Standardized protocol was followed for bracket bonding procedure and archwire sequence. Subject pain was recorded using a Verbal Rating Scale to assess discomfort felt on the teeth and soft tissues at the time of the appointment and 1, 3, and 5 days after each archwire change up to the working archwire. Multilevel modeling was used to analyze the data by blinded assessors. Results:  One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed the study and 113 (82%) returned the required data regarding pain/discomfort. Perceived pain was statistically higher with the SmartClip™ system compared to the Victory™ system, but this difference was not deemed to be clinically significant. Discomfort was greatest after placement of the initial 0.014-inch nickel-titanium archwire, compared with subsequent wires, and was greatest on day 1, less on day 3, and much less on day 5 after each archwire change. Age and gender did not affect the level of discomfort experienced by subjects undergoing fixed appliance treatment. Conclusion:  No clinically significant difference in pain experience was found between patients treated with a self-ligating bracket system compared to those treated with a conventional ligation system.

scholarly journals A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency

2015 ◽  
Vol 86 (1) ◽  
pp. 142-148 ◽  
Author(s):  
Lian O'Dywer ◽  
Simon J. Littlewood ◽  
Shahla Rahman ◽  
R. James Spencer ◽  
Sophy K. Barber ◽  
...  
Keyword(s):  
Treatment Time ◽  
Controlled Trial ◽  
Random Sequence ◽  
Controlled Clinical Trial ◽  
Treatment Efficiency ◽  
Duration Of Treatment ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Clinically Significant ◽  
Receive Treatment

ABSTRACT Objective:  To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. Materials and Methods:  A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. Results:  One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. Conclusions:  There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

scholarly journals Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

2017 ◽  
Vol 10 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Katharine Hamlin ◽  
Christopher Munro ◽  
Scott L. Barker ◽  
Sean McKenna ◽  
Kapil Kumar
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Open Release ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

2020 ◽  
pp. 026921552096505
Author(s):  
Vanessa González-Rueda ◽  
Carlos López-de-Celis ◽  
Elena Bueno-Gracia ◽  
Jacobo Rodríguez-Sanz ◽  
Albert Pérez-Bellmunt ◽  
...  
Keyword(s):  
Neck Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Chronic Neck Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Primary Care Center ◽  
Randomized Controlled ◽  
Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

Palliative Oxygen Versus Room Air for Refractory Dyspnea (DRAFT)

2018 ◽  
Author(s):  
Jason A. Webb ◽  
Arif H. Kamal
Keyword(s):  
Randomized Controlled Trial ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Nasal Cannula ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Clinically Significant ◽  
International Multicenter ◽  
Symptomatic Benefit

Palliative oxygen therapy is used for treating dyspnea in patients with cancer and advanced cardiopulmonary diseases, however, small trials have suggested that circulating air may be just as effective. This international, multicenter, randomized controlled trial compared oxygen versus room air delivered by a nasal cannula for relief of dyspnea for patients with any life-limiting illness. Patients were adults >18 years of age, with PaO2 > 7.3kPa, on optimized therapies for their illness, and an expected survival of >1 month. The study demonstrated no clinically significant symptomatic benefit of palliative oxygen versus room air delivered via nasal cannula for seven days in patients with life-limiting illnesses and refractory dyspnea.

scholarly journals Post-turbinectomy Nasal Packing with Merocel versus Glove Finger Merocel: A Prospective, Randomized, Controlled Trial

2018 ◽  
Vol 97 (3) ◽  
pp. 64-68 ◽  
Author(s):  
Rani Abu Eta ◽  
Ephraim Eviatar ◽  
Jacob Pitaro ◽  
Haim Gavriel
Keyword(s):  
Tranexamic Acid ◽  
Controlled Trial ◽  
Visual Analog Scale Score ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference ◽  
Acid Consumption ◽  
Glove Finger ◽  
Group A

Nasal packs are widely used after septoplasty and turbinectomy. We conducted a prospective, randomized, controlled clinical trial including 100 patients who underwent septoplasty with/or without turbinectomy randomized into two groups. In the first group (the Merocel group), a standard tampon was inserted at the end of surgery. In the second group (the glove finger group), the tampon was first placed inside a glove finger. The main outcomes measured were pain and bleeding during the postoperative period and during tampon removal. Consumption of pain killers and tranexamic acid were also recorded. The mean visual analog scale score 12 hours after surgery and during tampon removal in the Merocel group were 6.78 and 8.92, respectively, compared to 4.06 and 5.27, respectively, in the glove finger group (p < 0.001). A statistically significant difference in the bleeding rate and tranexamic acid consumption during tampon removal in favor of the Merocel group was shown (p < 0.001). The use of Merocel in a glove finger is significantly less painful, although a higher chance of bleeding is reported. The influence of the surgeon's experience in using this technique needs further investigation.

scholarly journals A Randomized Controlled Trial of Misoprostol and Sulprostone to End Pregnancy after Fetal Death

2009 ◽  
Vol 2009 ◽  
pp. 1-8 ◽  
Author(s):  
Kristin Van Mensel ◽  
Filip Claerhout ◽  
Patrick Debois ◽  
Marc J. N. C. Keirse ◽  
Myriam Hanssens
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Pain Perception ◽  
Fetal Death ◽  
Controlled Trial ◽  
Freedom Of Movement ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Gastrointestinal Side Effects ◽  
Vaginal Misoprostol

Objective. To compare effectiveness, side effects, and patients' perception of vaginal misoprostolversusintravenous sulprostone for ending pregnancy after fetal death between 14 and 42 weeks gestation.Method. Multicenter randomized controlled trial, using block randomization, central allocation, and prior power analysis.Outcome measures. Induction-delivery interval, gastrointestinal side effects, use of analgesia, pain perception, pyrexia, placental retention, hemorrhage, and women's opinions.Results. Of 176 women aimed for, 143 were randomized over 7 years, of whom 4 were excluded. There was no difference in delivery within 24 and 36 hours: 91.4% and 97.1% with misoprostol ()versus85.5% and 92.8% with sulprostone (). There was no difference in either gastrointestinal side effects, as reported by the women and their caregivers, use of analgesia, women's pain perception, blood loss or placental retention. Hyperthermia 38°C was more common with misoprostol (24.3%) than with sulprostone (11.6%; difference: +12.7%; 95% CI: +1.2% to +25.3%) and related to the total dose used. Acceptability of both induction methods was similar except for freedom of movement, which was substantially in favor of misoprostol (lack of freedom reported with misoprostol in 34.3%versus63.8% with sulprostone; difference: −29.5%; 95% CI: −13.6% to −45.4%).Conclusions. Misoprostol and sulprostone are similarly effective with little difference in side effects except for hyperthermia, related to the dose of misoprostol used, and women's reported lack of mobility with intravenous sulprostone. Effectiveness of both methods increased with gestational age.

scholarly journals Role of New Hydrophilic Surfaces on Early Success Rate and Implant Stability: 1-Year Post-loading Results of a Multicenter, Split-Mouth, Randomized Controlled Trial

2020 ◽  
Author(s):  
Marco Tallarico ◽  
Nicola Baldini ◽  
Fulvio Gatti ◽  
Matteo Martinolli ◽  
Erta Xhanari ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Survival Rates ◽  
Insertion Torque ◽  
Implant Stability ◽  
Randomized Controlled ◽  
Group Outcomes ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial

Abstract Objective To compare early implant failure and implant stability of one-stage Hiossen ET III implants with its new hydrophilic (NH) surface, compared with Hiossen ET III implants with the sandblasted and acid-etched (SA) surface at 1-year follow-up. Materials and Methods This study was designed as a split-mouth, multicenter randomized controlled trial aimed to compare SA surface implants (SA group) and NH surface, (NH group). Outcomes were implant and prosthetic survival rates, complications, the insertion torque at implant placement, and implant stability quotient (ISQ) values. Results Twenty-nine patients (mean age 59.9 ± 11.3 years) were treated and followed up to 1 year after loading. No patient dropped out. Fifty-eight implants (29 SA group and 29 NH group) were placed. No implants or prostheses failed and no complications were experienced during follow-up. The mean insertion torque was 40.5 ± 3.23 (38.17–41.83) Ncm in the SA group and 40.48 ± 3.49 (38.02–41.98) Ncm in the NH group (p = 0.981). There was a statistically significant difference at the second week (T2) with higher values in the NH group (p = 0.041). Similar results were found in the maxilla (p = 0.045), but not in the mandible (p = 0.362). A positive correlation was found between initial insertion torque and ISQ with higher value in the NH group (0.73 vs. 0.66). Conclusions NH implants are a viable alternative to SA surface, as they seem to avoid the ISQ drop during the bone remodeling phase.

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