Clinical Evaluation of a New Electronic Periodontal Probe: A Randomized Controlled Clinical Trial

Precise measurements of periodontal parameters (such as pocket depths: PPD, gingival margins: GM) are important for diagnosis of periodontal disease and its treatment. Most examiners use manual millimeter-scaled probes, dependent on adequate pressure and correct readouts. Electronic probes aim to objectify and facilitate the diagnostic process. This randomized controlled trial compared measurements of a standard manual (MP) with those of an electronic pressure-sensitive periodontal probe (EP) and its influence on patients’ acceptance and practicability. In 20 patients (2436 measuring points) PPD and GM were measured either with MP or EP by professionals with different levels of experience: dentist (10 patients), 7th and 10th semester dental students (5 patients each). Time needed was measured in minutes and patients’ subjective pain was evaluated by visual analogue scale. Differences were analyzed using the generalized estimating equations approach (GEE) and paired Wilcoxon tests. Mean PPD varied with ΔPPD 0.38 mm between both probes, which was significant (p < 0.001), but GM did not (ΔREC 0.07 mm, p = 0.197). There was a statistically significant correlation of both probes (Spearman’s rho correlation coefficient GM: 0.674, PPD: 0.685). Differences can be considered robust (no deviation in either direction). The comparison of time needed and pain sensitivity did not result in statistically significant differences (p > 0.05).

Download Full-text

Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial

BMC Pediatrics ◽

10.1186/s12887-021-02635-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mandy B. Belfort ◽

Lianne J. Woodward ◽

Sara Cherkerzian ◽

Hunter Pepin ◽

Deirdre Ellard ◽

...

Keyword(s):

Human Milk ◽

Brain Size ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Milk Analysis ◽

Single Center ◽

Current Standard ◽

Very Preterm ◽

Randomized Controlled

Abstract Background Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. Methods We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks’ gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks’ postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks’ PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years’ corrected age. Discussion We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). Trial registration NCT03977259, registered 6 June, 2019.

Download Full-text

The Effects of Dry Needling to the Thoracolumbar Junction Multifidi on Measures of Local and Remote Flexibility and Pain Sensitivity: A Randomized Controlled Trial

Musculoskeletal Science and Practice ◽

10.1016/j.msksp.2021.102366 ◽

2021 ◽

pp. 102366

Author(s):

Nicole G. Clark ◽

Cheryl J. Hill ◽

Shane L. Koppenhaver ◽

Thomas Massie ◽

Joshua A. Cleland

Keyword(s):

Randomized Controlled Trial ◽

Pain Sensitivity ◽

Controlled Trial ◽

Thoracolumbar Junction ◽

Dry Needling ◽

Randomized Controlled

Download Full-text

Intrathecal dexmedetomidine improves epidural labor analgesia effects: a randomized controlled trial

Journal of International Medical Research ◽

10.1177/0300060521999534 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052199953

Author(s):

Gehui Li ◽

Hao Wang ◽

Xiaofei Qi ◽

Xiaolei Huang ◽

Yuantao Li

Keyword(s):

Local Anesthetic ◽

Controlled Trial ◽

Intrathecal Injection ◽

Onset Time ◽

Labor Analgesia ◽

Controlled Clinical Trial ◽

Time Duration ◽

Clinical Registry ◽

Randomized Controlled ◽

Group D

Objective α2‑agonists and opioids have been used as intrathecal adjuvants to local anesthetics for several years, but the effect of intrathecal dexmedetomidine (Dex) or sufentanil combined with epidural ropivacaine in labor analgesia is not fully understood. Methods A total of 108 parturient women receiving combined spinal-epidural labor analgesia were randomly divided into three groups. Group C received l mL saline (0.9%) intrathecally, Group D received 5 µg Dex intrathecally, and Group S received 5 µg sufentanil intrathecally. All parturient women then received 0.1% epidural ropivacaine and 0.2 µg/mL sufentanil for patient-controlled epidural analgesia with standard settings. The visual analog scale score, onset time, duration of intrathecal injection, local anesthetic requirements, and side effects were recorded. Results The labor analgesia effects in Groups D and S were better than those in Group C. Groups D and S displayed significantly shorter onset times, longer durations of intrathecal injection, and reduced local anesthetic requirements compared with Group C. The incidence of shivering and pruritus in Group D was lower than that in Group S. Conclusion Intrathecal administration of 5 µg Dex could improve epidural labor analgesia effects. This randomized controlled clinical trial was registered with the Chinese Clinical Registry Center (ChiCTR-1800014943, http://www.chictr.org.cn/ ).

Download Full-text

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

10.21203/rs.3.rs-707319/v1 ◽

2021 ◽

Author(s):

Yafang Guo ◽

Hong Lu ◽

Jing Gan ◽

Dongdong Li ◽

Jiandong Gao ◽

...

Keyword(s):

Herbal Medicine ◽

Chinese Herbal Medicine ◽

Serum Uric Acid Level ◽

Controlled Trial ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Chinese Herbal ◽

To Receive ◽

Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

Download Full-text

Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients

10.21203/rs.3.rs-468283/v1 ◽

2021 ◽

Author(s):

Siyuan Li ◽

Ke Yang ◽

Jingyi Wang ◽

Shang Li ◽

Lei Zhu ◽

...

Keyword(s):

Group Treatment ◽

Controlled Trial ◽

Anterior Segment ◽

Meibomian Gland ◽

Chinese Patients ◽

Meibomian Gland Dysfunction ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Meibomian Glands ◽

Thermostatic Device

Abstract BackgroundAs a chronic disease, meibomian gland dysfunction (MGD) which causes excessive evaporation of tears by changing the tear film composition, is considered a leading cause of dry eye. Although a variety of physical therapy equipment, there is currently no economical and effective treatment for MGD. The aim of this study was to evaluate the effectiveness and safety of the MiBoFlo Thermoflo® (Mibo Medical, Dallas, TX, USA), a new thermostatic device, on both objective symptoms and subjective signs in Chinese MGD patients.MethodsThis was a prospective, randomized, controlled clinical trial. 108 eyes of 54 MGD patients in Beijing Tongren Hospital were recruited and randomized 1:1 to MiBoFlo (n = 54 eyes) or LipiFlow® (TearScience, Morrisville, NC, USA) (n = 54 eyes) treatment group. In the MiBoFlo group, treatment for each eye took 10 minutes and proceeded every two weeks for a total of three times. Patients in the LipiFlow group received a single 12-minute treatment. Main Outcome Measures: The primary outcomes include changes in Ocular Surface Disease Index (OSDI) score, Meibomian Glands Yielding Liquid Secretion (MGYLS) score and Meibomian Glands Secretion (MGS) score from baseline to 2 months. The secondary outcomes include Tear Meniscus Height (TMH), Non-invasive Keratograph Break-up Time (NIKBUT), Corneal Fluorescein Staining (CFS) and Meibomian Glands (MG) loss from baseline to 2 months. Safety outcomes include visual acuity (VA), intraocular pressure (IOP), anterior segment and facial skin.ResultsThe OSDI score, MGYLS score and MGS score all improved from baseline to 1 month in both MiBoFlo and LipiFlow group, and these improvements were maintained at 2 months. CFS score, NIKBUT and MG loss had no significant change in both groups. CFS score improvement in MiBoFlo group were significantly more obvious than in LipiFlow group in the follow-up visit (p<0.01).ConclusionAs a portable and comfortable device, MiBoFlo treatment can offer an advancement for the treatment of MGD and a course of treatment results in at least two months of sustained improvement in both symptoms and meibomain gland function.

Download Full-text

Increasing Community College Graduation Rates: A Synthesis of Findings on the ASAP Model From Six Colleges Across Two States

Educational Evaluation and Policy Analysis ◽

10.3102/01623737211036726 ◽

2021 ◽

pp. 016237372110367

Author(s):

Cynthia Miller ◽

Michael J. Weiss

Keyword(s):

New York ◽

Controlled Trial ◽

College Graduation ◽

Randomized Controlled ◽

College Graduation Rates ◽

Associate's Degree ◽

Levels Of Service ◽

The City ◽

Permanent Increase ◽

Different Levels

This paper presents new estimates of the effects of the City University of New York’s ( CUNY’s) Accelerated Study in Associate Programs ( ASAP) model, evaluated using a randomized controlled trial first in New York and later through a replication in Ohio. It presents longer-term effects of CUNY ASAP in New York, showing that the program’s effect on associate’s degree receipt persisted through 8 years and likely represents a permanent increase in degree receipt. It also presents an analysis from the pooled study samples in New York and Ohio. The findings indicate that the program had consistent effects on degree receipt across the two states but also for somewhat different levels of service contrast, such as the number of additional advising visits.

Download Full-text

App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

10.2196/preprints.19624 ◽

2020 ◽

Author(s):

Stephanie Erika Bonn ◽

Mari Hult ◽

Kristina Spetz ◽

Marie Löf ◽

Ellen Andersson ◽

...

Keyword(s):

Physical Activity ◽

Bariatric Surgery ◽

Controlled Trial ◽

Intervention Group ◽

Study Participant ◽

Lifestyle Factors ◽

Lifestyle Changes ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

Download Full-text

Mirror therapy for phantom limb and stump pain: a randomized controlled clinical trial in landmine amputees in Cambodia

Scandinavian Journal of Pain ◽

10.1515/sjpain-2018-0042 ◽

2018 ◽

Vol 18 (4) ◽

pp. 603-610 ◽

Cited By ~ 4

Author(s):

Ha Sam Ol ◽

Yang Van Heng ◽

Lena Danielsson ◽

Hans Husum

Keyword(s):

Low Income ◽

Controlled Trial ◽

Phantom Limb Pain ◽

Phantom Limb ◽

Controlled Clinical Trial ◽

Mirror Therapy ◽

Randomized Controlled ◽

Stump Pain ◽

The Difference ◽

Therapy Interventions

Abstract Background and aims The aim of the study was to examine the effect of mirror and tactile therapy on phantom and stump pain in patients with traumatic amputations, with particular reference to amputees in low-income communities. Methods The study was conducted with an open, randomized, semi-crossover case-control design in rural Cambodia. A study sample of 45 landmine victims with trans-tibial amputations was allocated to three treatment arms; mirror therapy, tactile therapy, and combined mirror-and-tactile therapy. Non-responders from the mono-therapy interventions were crossed over to the alternative intervention. The intervention consisted of 5 min of treatment every morning and evening for 4 weeks. Endpoint estimates of phantom limb pain (PLP), stump pain, and physical function were registered 3 months after the treatment. Results All three interventions were associated with more that 50% reduction in visual analogue scale (VAS)-rated PLP and stump pain. Combined mirror-tactile treatment had a significantly better effect on PLP and stump pain than mirror or tactile therapy alone. The difference between the three treatment arms were however slight, and hardly of clinical relevance. After treatment, the reduction of pain remained unchanged for an observation period of 3 months. Conclusions The study documents that a 4-week treatment period with mirror and/or tactile therapy significantly reduces PLP and stump pain after trans-tibial amputations. Implications The article reports for the first time a randomized controlled trial of mirror therapy in a homogenous sample of persons with traumatic amputations. The findings are of special relevance to amputees in low-resource communities.

Download Full-text

A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design

The Bone & Joint Journal ◽

10.1302/0301-620x.102b9.bjj-2020-0096.r1 ◽

2020 ◽

Vol 102-B (9) ◽

pp. 1158-1166

Author(s):

Bart L. Kaptein ◽

Peter den Hollander ◽

Bregje Thomassen ◽

Martha Fiocco ◽

Rob G. H. H. Nelissen

Keyword(s):

Tibial Component ◽

Controlled Trial ◽

Weight Bearing ◽

Controlled Clinical Trial ◽

Fixed Bearing ◽

Cruciate Retaining ◽

Cement Interface ◽

Randomized Controlled ◽

Press Fit ◽

Patient Reported

Aims The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). Methods A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. Results The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). Conclusion In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article: Bone Joint J 2020;102-B(9):1158–1166.

Download Full-text