Pain Experience with Micro-osteoperforations during Initial Orthodontic Alignment: A Randomized Clinical Trial.

Objetive: The objective of this clinical trial was to investigate the perception of pain during initial maxillary alignment with an adjunctive procedure of micro-osteoperforations (MOPs) compared to conventional orthodontics. Material and methods: This study design was a single-centre, two-arm parallel prospective randomised clinical trial. Thirty consecutive adult subjects (25 females and 5 males; mean age ± SD, 22.66 ± 3.27 years) with 5-8mm moderate upper labial segment crowding were randomly allocated using block randomisation into intervention and control group. All subjects had first premolar extractions, bonded conventional fixed appliances and 0.014-inch nickel-titanium archwire was placed for initial alignment. The intervention group received a 3-mm deep MOPs procedure under local anaesthesia using a Propel device (PROPEL Ortho Singapore) on the labiogingival aspect between the maxillary incisors. Both groups received a set of 100 mm visual analogue scale to complete over the first week, recording pain at 24 hours, 3 days and 1 week. Data were analysed using repeated-measures analysis of variance (ANOVA). Results: There was a statistically significant difference observed in perceived pain levels between MOPs and the control group on day 1, day 3 and day 7 postoperatively. Pain perception was significantly lower in the intervention group at all time points. Conclusion: Accelerating orthodontic tooth movement with MOPs did not accentuate pain perceived during initial maxillary alignment with fixed appliances.

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The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial

European Journal of Dentistry ◽

10.4103/ejd.ejd_424_17 ◽

2018 ◽

Vol 12 (03) ◽

pp. 350-357 ◽

Cited By ~ 4

Author(s):

Azita Tehranchi ◽

Hossein Behnia ◽

Fereydoun Pourdanesh ◽

Parsa Behnia ◽

Nelson Pinto ◽

...

Keyword(s):

Clinical Trial ◽

Tooth Movement ◽

Random Effect ◽

Random Effect Model ◽

Orthodontic Tooth Movement ◽

Control Group ◽

Extraction Socket ◽

Effect Model ◽

Significant Difference ◽

And Control

ABSTRACT Objective: The aim of this study was to evaluate the effect of LPRF, placed in extraction sockets, on orthodontic tooth movement (OTM). Materials and Methods: Thirty extraction sockets from eight patients (five males, three females, with a mean age of 17.37 years; range 12–25 years) requiring extraction of first premolars based on their orthodontic treatment plan participated in this split-mouth clinical trial. In one randomly selected quadrant of each jaw, the extraction socket was preserved as the experimental group by immediate placement of LPRF in the extraction socket. The other quadrant served as the control group for secondary healing. Immediately, the teeth adjacent to the defects were pulled together by a NiTi closed-coil spring with constant force. A piece of 0.016 × 0.022-inch stainless steel wire was used as the main arch wire. The amount of OTM was measured on the study casts at eight time points with 2-week intervals for 3 months. Analysis of random effect model was performed for the purpose of comparison between the experimental and control groups. Results: According to the random effect model, a statistically significant difference was found between the experimental and control group in rate of OTM (P = 0.006). Conclusion: According to the results, application of LPRF, as an interdisciplinary approach combining orthodontics and surgery, may accelerate OTM, particularly in extraction cases.

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Barati ◽

Mina Iravani ◽

Majid Karandish ◽

Mohammad Hosein Haghighizadeh ◽

Sara Masihi

Keyword(s):

Clinical Trial ◽

Blood Glucose ◽

Gestational Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Standard Diet ◽

Oat Bran ◽

Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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The Effect of the Mobile ‘Blood Pressure Management Application’ on Hypertension Self-Management Enhancement: A Randomised Controlled Trial

10.21203/rs.2.1820/v2 ◽

2019 ◽

Author(s):

Ali Bozorgi ◽

Hamed Hosseini ◽

Hassan Eftekhar ◽

Reza Majdzadeh ◽

Ali Yoonessi ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Clinical Trial ◽

Repeated Measures ◽

Patient Adherence ◽

Intervention Group ◽

Public Hospitals ◽

Self Management ◽

Control Group ◽

Management Application

Abstract Background : Self-management of blood pressure is of great significance given the increasing incidence of hypertension and associated disabilities. With the increased use of mobile health in medicine, the present study evaluated the effect of the self-management application on patient adherence to hypertension treatment. Methods : This clinical trial was performed on 120 hypertensive patients who were provided with a mobile intervention for 8 weeks and followed-up to 24 th weeks. Data on the primary outcome (adherence to treatment) and secondary outcomes (adherence to the DASH diet, regular monitoring of blood pressure, and physical activity) were collected using a questionnaire and a mobile application, respectively. The inter-group change difference over time was analyzed using repeated measures ANOVA (General Linear Model). Results : The treatment adherence score increased by an average of 5.9 (95%CI: 5.0-6.7) in the intervention group compared to the control group. Scores of adherence to the low-fat and low-salt diet plans were 1.7 (95%CI: 1.3-2.1) and 1.5 (95%CI: 1.2-1.9), respectively. Moreover, moderate physical activity increased to 100.0 minutes (95%CI: 61.7-138.3) per week in the intervention group. Conclusion: The treatment and control of blood pressure require a multifaceted approach given its complexity and multifactorial nature. Considering the widespread use of smartphones , mhealth interventions can be effective in self-management and better patient adherence to treatments. Our results showed that this application can be used as a successful tool for hypertension self-management in patients attending public hospitals in developing countries. Trial registration: This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

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The effect of continuous care model-based intervention on the quality of sleep in menopausal women: A clinical trial study

10.21203/rs.2.14033/v1 ◽

2019 ◽

Author(s):

Farzaneh AKBARI ◽

sousan Heydarpour ◽

Nader Salari

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Control Group ◽

Quality Of Sleep ◽

Care Model ◽

Continuous Care ◽

Menopausal Women ◽

Significant Difference ◽

The Difference

Abstract BACKGROUND Sleep disorder, brings in many physical, behavioral, and mental problems. Applying continuous care model leads to proper recognition of the patient’s problems and involves the patient in solving health problems. This study aimed to determine the effect of continuous care model on the quality of sleep in menopausal women. METHODS AND MATERIALS A random clinical trial study was carried out with participation of 110 menopausal women visiting Kermanshah-based clinics (the west of Iran) in 2017. The participants were randomly assigned to intervention (n=55) and control (n=55) groups. The control group received the routine cares and in addition to the routine cares the intervention group attended four weekly group consultation sessions (60-90min). The quality of sleep in the two groups was assessed using Pittsburg Sleep Quality Index before, immediately after, and one month after the intervention. Data analyses were done using independent t-test, ANOVA with frequent measures, Friedman’s test, Wilcoxon’s post hoc test, and X2 test in SPSS (24). RESULTS The mean scores of quality of sleep before and after the intervention were significantly different in the intervention group (p=0.001). There was no significant difference between the two groups in terms of quality of sleep before (p=0.140) and immediately after the intervention (p=0.168). However, one month after, the difference between the two groups was significant (P<0.001). CONCLUSION Implementation of the continuous care model led to an improvement of quality of sleep in the menopausal women.

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Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2018012503421 ◽

2019 ◽

Vol 53 ◽

Author(s):

Luciana Regina Ferreira da Mata ◽

Cissa Azevedo ◽

Mariana Ferreira Vaz Gontijo Bernardes ◽

Tânia Couto Machado Chianca ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Home Care ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Teaching Program ◽

Significant Difference ◽

The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

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Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002618 ◽

2020 ◽

pp. bmjspcare-2020-002618

Author(s):

Azam Dehghani ◽

Ali Hajibagheri ◽

Ismail Azizi-Fini ◽

Fatemeh Atoof ◽

Noushin Mousavi

Keyword(s):

Clinical Trial ◽

Laparoscopic Surgery ◽

Pain Intensity ◽

Repeated Measures ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Early Mobilisation ◽

Repeated Measures Analysis ◽

The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

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Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial

The Angle Orthodontist ◽

10.2319/072115-492.1 ◽

2015 ◽

Vol 86 (4) ◽

pp. 625-630 ◽

Cited By ~ 20

Author(s):

Wendy D. Lobre ◽

Brent J. Callegari ◽

Gary Gardner ◽

Curtis M. Marsh ◽

Anneke C. Bush ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Pain Perception ◽

Control Group ◽

Eligibility Criteria ◽

Pain Scores ◽

Parallel Group ◽

Repeated Measures Analysis ◽

The Relationship

ABSTRACT Objective: To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. Materials and Methods: This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n = 29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α = .05. Results: During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P = .002) and biting pain (P = .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. Conclusion: The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

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Effect of lifestyle education based on Pender model on health-promoting behaviors in HIV positive individuals: A randomized clinical trial study

Nursing Practice Today ◽

10.18502/npt.v7i1.2299 ◽

2020 ◽

Author(s):

Farah Khani ◽

Shahzad Pashaeypoor ◽

Nasrin Nikpeyma

Keyword(s):

Physical Activity ◽

Clinical Trial ◽

Interpersonal Relationships ◽

Spiritual Growth ◽

Intervention Group ◽

Control Group ◽

Hiv Patients ◽

Health Promoting Behaviors ◽

Significant Difference ◽

Health Promoting

Background & Aim: Human Immunodeficiency Virus (HIV) prevalence is increasing, and this disease has become a crisis for the modern world. Today, the survival of patients has been increased, such that HIV is considered a chronic disease. So, Paying attention to health-promoting intervention is necessary. Thus, the current study aims to determine the effect of educating lifestyle based on the Pender model on health-promoting behaviors in HIV patients. Methods & Materials: In this randomized clinical trial study, 70 HIV patients who had inclusion criteria were selected and then divided into intervention and control groups randomly. The intervention group received 6 one-hour education sessions weekly based on Pender lifestyle (nutrition, physical activity, stress management, spiritual growth, interpersonal relationships, and health responsibility). A demographic questionnaire and HPLP2 were used, which were completed by both groups before the intervention and 8 weeks after the intervention. Chi-Square, Fisher, Independent t, and ANCOVA statistical tests and SPSS 16 software were used to analyze data. Results: results showed that there was no significant difference in various dimensions of health-promoting lifestyle between two groups before intervention. However, intervention group scores for nutrition (28.08±6.23 vs. 23.58±6.04), physical activity (22.26±6.46 vs. 16.39±6.09), stress management (25.03±5.14 vs. 19.96±6.41), spiritual growth (29.49±6.11 vs. 25.45±8.54), interpersonal relationships (29.17±6.14 vs. 23.11±7.45) and health responsibility (28.36±6.06 vs. 23.89±5.74) were significantly higher than control group 8 weeks after intervention. Moreover, the total score of health-promoting behaviors had a significant difference in the intervention group compared to the control group (166.7±28.43 vs. 134.5±35.68, p<0.001). Conclusion: Based on the findings, it can be said that educating lifestyle based on the Pender model causes HIV patients to use health-promoting behaviors, which are recommended as a useful theory-based program for managers and providers of health services.

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The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

Galen Medical Journal ◽

10.31661/gmj.v4i1.168 ◽

2015 ◽

Vol 4 (1) ◽

pp. 26-32

Author(s):

Sara Azima ◽

Hajar Rajaei Bakhshayesh ◽

Keramatollah Abbasnia ◽

Maasumeh Kaviani ◽

Mehrab Sayadi

Keyword(s):

Clinical Trial ◽

Pain Intensity ◽

Repeated Measures ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Primary Dysmenorrhea ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

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