Skeletal and dentoalveolar effects using tooth-borne and tooth-bone-borne RME appliances: a randomized controlled trial with 1-year follow-up

2020 ◽  
Author(s):  
Farhan Bazargani ◽  
Henrik Lund ◽  
Anders Magnuson ◽  
Björn Ludwig
Keyword(s):  
Nasal Cavity ◽  
Controlled Trial ◽  
Upper Airway ◽  
Clinical Results ◽  
Maxillary Expansion ◽  
Eligibility Criteria ◽  
Midpalatal Suture ◽  
Clinically Significant ◽  
Plaster Models

Summary Objectives To evaluate and compare the skeletal and dentoalveolar effects of tooth-borne (TB) and tooth-bone-borne (TBB) rapid maxillary expansion (RME). Materials and methods Fifty-two consecutive patients who met the eligibility criteria were recruited and allocated to either the TB group, mean age 9.3 years [standard deviation (SD) 1.3], or the TBB group, mean age 9.5 years (SD 1.2). Cone-beam computed tomography (CBCT) records and plaster models were taken before (T0), directly after (T1), and 1 year after expansion (T2). Dentoalveolar and skeletal measurements were made on the CBCT images. The dental expansion was also measured on the plaster models. Randomization Participants were randomly allocated in blocks of different sizes using the concealed allocation principle in a 1:1 ratio. The randomization list was also stratified by sex to ensure homogeneity between groups. Blinding Due to clinical limitations, only the outcomes assessors were blinded to the groups to which the patients were allocated. Results Skeletal expansion in the midpalatal suture and at the level of the nasal cavity was significantly higher in the TBB group. However, the magnitude of the expansion in the midpalatal suture was around 1 mm [95 per cent confidence interval (CI) 0.5–1.7, P = 0.001] more and perhaps not clinically significant. The magnitude of the expansion at the level of the nasal cavity was almost two times higher in the TBB group (95 per cent CI 0.7–2.6, P = 0.001). The dental expansion, alveolar bending, tipping of the molars, and stability 1 year post-expansion did not show any statistically significant differences between the groups. The actual direct cost of the treatment for the TBB group was approximately €300 higher than TB group. Limitations Double blinding was not possible due to the clinical limitations. Conclusions In young preadolescents with constricted maxilla and no signs of upper airway obstruction, it seems that conventional TB RME achieves the same clinical results with good stability 1 year post-expansion at lower cost. Trial registration The trial was not registered.

Spinal Cord Stimulation Electrode Design: A Prospective, Randomized, Controlled Trial Comparing Percutaneous with Laminectomy Electrodes: Part II–Clinical Outcomes

Neurosurgery ◽  
2005 ◽  
Vol 57 (5) ◽  
pp. 990-996 ◽  
Author(s):  
Richard B. North ◽  
David H. Kidd ◽  
Loredana Petrucci ◽  
Michael J. Dorsi
Keyword(s):  
Spinal Cord ◽  
Controlled Trial ◽  
Clinical Results ◽  
Failed Back Surgery Syndrome ◽  
Electrode Placement ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients. METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined “success” as at least 50% sustained relief of pain and patient satisfaction with the result of treatment. RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed. CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.

scholarly journals Efficacy of conventional fluoridated toothpastes containing arginine and high-fluoride toothpastes on the control of root caries in patients undergone radiotherapy of head-and-neck: a randomized controlled trial

2021 ◽  
Author(s):  
Marilia Velo ◽  
Marina Giacominni ◽  
Leticia Brianezzi ◽  
Rafael Gonçalves ◽  
Giovanna Zabeu ◽  
...  
Keyword(s):  
Head And Neck ◽  
Controlled Trial ◽  
Glass Ionomer Cement ◽  
Similar Efficacy ◽  
Root Caries ◽  
Eligibility Criteria ◽  
High Fluoride ◽  
Usphs Criteria ◽  
Caries Lesions

Abstract This parallel, triple-blind RCT evaluated the restorative performance of a resin-modified glass-ionomer-cement (RMGIC) in irradiated patients and the prevention of root caries lesions adjacent to restoration, comparing the effect of conventional (control) concentration, high-fluoride (F) containing fTCP and arginine-based toothpastes. A total of 63 lesions was screened and 60 were included into randomized distribution into three groups (N- participants in baseline/n- root caries lesions): G1 = 1,450 ppm F (N = 10/n = 17); G2 = 5,000 ppm F + fTCP (N = 7/n = 18) and G3 = 1,450 ppm F + arginine + CaCO3 (N = 6/n = 25). Based on eligibility criteria, all patients were mandatory enrolled after completed 3-month of radiotherapy of head-and-neck. Two calibrated operators performed the restorative procedures (RMGIC - Vitremer) and two calibrated examiners (Kappa = 0.94) evaluated the restorations based on modified USPHS criteria at baseline, 1, 3 and 6-month follow-up. Data was collected and statistically assessed with Kruskal-Wallis test (p < 0.05). There were no statistically significance differences among the performance of the restoration among the three groups regarding the criteria retention, marginal adaptation, marginal staining, post-operative sensitivity, adjacent caries, color alteration, anatomic form and surface texture (p > 0.05). Even with oral complications caused by radiation-therapy, if the restorations are properly performed and patients are under professional supervision, high-F presented similar efficacy of arginine and conventional-containing toothpastes to prevent secondary caries. Clinical relevance: This clinical trial brings new evidences about the regular use of high-F, arginine-based and conventional-F containing toothpastes in irradiated patients under supervision of a multidisciplinary team and the encouragement of self-cooperation.

scholarly journals Treatment of symptomatic degenerative intervertebral discs with autologous platelet-rich plasma: follow-up at 5–9 years

2019 ◽  
Vol 14 (9) ◽  
pp. 831-840 ◽  
Author(s):  
Jennifer Cheng ◽  
Kristen A Santiago ◽  
Joseph T Nguyen ◽  
Jennifer L Solomon ◽  
Gregory E Lutz
Keyword(s):  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Intervertebral Discs ◽  
Discogenic Pain ◽  
Autologous Platelet Rich Plasma ◽  
Clinically Significant ◽  
And Function ◽  
Pain Patients ◽  
Autologous Platelet

Aim: This study assessed pain and function at 5–9 years postinjection in a subset of patients who received intradiscal platelet-rich plasma (PRP) injections for moderate-to-severe lumbar discogenic pain. Patients & methods: All patients received injections of intradiscal PRP in a previous randomized controlled trial. Data on pain, function, satisfaction, and need for surgery were collected at one time point of 5–9 years postinjection and compiled with existing data. Results: In comparison to baseline, there were statistically significant improvements in pain and function (p < 0.001). All improvements were clinically significant. Six patients had undergone surgery during the follow-up period. Conclusion: This subset of patients demonstrated statistically and clinically significant improvements in pain and function at 5–9 years postinjection.

scholarly journals Embodying self-compassion within virtual reality and its effects on patients with depression

BJPsych Open ◽  
2016 ◽  
Vol 2 (1) ◽  
pp. 74-80 ◽  
Author(s):  
Caroline J. Falconer ◽  
Aitor Rovira ◽  
John A. King ◽  
Paul Gilbert ◽  
Angus Antley ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Controlled Trial ◽  
Immersive Virtual Reality ◽  
Depression Severity ◽  
Self Compassion ◽  
Clinically Significant ◽  
Clinical Potential ◽  
Further Development ◽  
Virtual Body

BackgroundSelf-criticism is a ubiquitous feature of psychopathology and can be combatted by increasing levels of self-compassion. However, some patients are resistant to self-compassion.AimsTo investigate whether the effects of self-identification with virtual bodies within immersive virtual reality could be exploited to increase self-compassion in patients with depression.MethodWe developed an 8-minute scenario in which 15 patients practised delivering compassion in one virtual body and then experienced receiving it from themselves in another virtual body.ResultsIn an open trial, three repetitions of this scenario led to significant reductions in depression severity and self-criticism, as well as to a significant increase in self-compassion, from baseline to 4-week follow-up. Four patients showed clinically significant improvement.ConclusionsThe results indicate that interventions using immersive virtual reality may have considerable clinical potential and that further development of these methods preparatory to a controlled trial is now warranted.

Results of a phase III, randomized, double-blind, placebo-controlled trial of pegfilgrastim (PEG) in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab (B) for colorectal cancer (CRC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3575-3575
Author(s):  
Tamas Pinter ◽  
Esteban Abella ◽  
Alvydas Cesas ◽  
Adina Croitoru ◽  
Jochen Decaestecker ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Double Blind ◽  
Free Survival ◽  
Clinically Significant ◽  
Grade 3

3575 Background: The literature reports that adding biologics to chemotherapy (ctx) may increase the incidence of clinically significant neutropenia. his trial was conducted to evaluate the efficacy of PEG in reducing the incidence of febrile neutropenia (FN) in pts with locally-advanced (LA) or metastatic (m)CRC receiving first-line treatment with either FOLFOX/B or FOLFIRI/B. Methods: Key eligibility: ≥ 18 years old; measurable, nonresectable CRC per RECIST 1.1. Pts were randomly assigned 1:1 to either placebo or 6 mg PEG ~24 h after ctx/B. The study treatment period included four Q2W cycles, but pts could continue their assigned regimen until progression. Pts were stratified by region (North America vs rest of world), stage (LA vs mCRC), and ctx (FOLFOX vs FOLFIRI). Estimated sample size (N = 800) was based on the expected incidence of grade 3/4 FN (primary endpoint) across the first 4 cycles of ctx/B, powered for PEG superiority over placebo. Other endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: 845 pts were randomized (Nov 2009 to Jan 2012) and received study treatment; 783 pts completed 4 cycles of ctx/B. Median age was 61 years; 512 (61%) pts were male; 819 (97%) had mCRC; 414 (49%) received FOLFOX, and 431 (51%) received FOLFIRI. Grade 3/4 FN (first 4 cycles) for placebo vs PEG was 5.7% vs 2.4%; OR 0.41; p = 0.014. A similar incidence of other ≥ grade 3 adverse events was seen in both arms (28% placebo; 27% PEG). See table for additional results. Conclusions: PEG significantly reduced the incidence of grade 3/4 FN in this pt population receiving standard ctx/B for CRC. Follow-up is ongoing. Clinical trial information: NCT00911170. [Table: see text]

Endovascular treatment of acutely ruptured and unruptured aneurysms of the basilar bifurcation

1997 ◽  
Vol 86 (2) ◽  
pp. 211-219 ◽  
Author(s):  
Jean Raymond ◽  
Daniel Roy ◽  
Michel Bojanowski ◽  
Robert Moumdjian ◽  
Georges L'Espérance
Keyword(s):  
Endovascular Treatment ◽  
Clinical Results ◽  
Aneurysm Rupture ◽  
Content Type ◽  
Unruptured Aneurysms ◽  
Complete Obliteration ◽  
Clinically Significant ◽  
Technical Complication ◽  
Fine Print

✓ The surgical treatment of basilar bifurcation aneurysms is difficult and the need for an alternative approach is frequently stated. To assess the efficacy and safety of endovascular treatment of aneurysms located at the basilar bifurcation, the authors prospectively studied angiographic results, clinical results, and complications in 31 patients treated with Guglielmi detachable coils (GDCs). Patients treated acutely after subarachnoid hemorrhage (SAH) were graded according to the Hunt and Hess classification and clinical outcome was determined at 1- and 6-month intervals according to the Glasgow Outcome Scale (GOS). There were 18 women and 13 men, ranging in age from 34 to 67 years (mean age 48 years). Twenty-three were treated acutely after SAH. Clinical Hunt and Hess grades at presentation were as follows: Grade I, six patients; Grade II, three; Grade III, 11; Grade IV, two; and Grade V, one. The GOS score for the group of patients treated acutely was: GOS I, 18 patients; GOS II, III, and IV, one patient each; and GOS V, two patients. There were seven technical complications in this group, most often asymptomatic, but one patient died after aneurysm rupture during treatment and one had residual diplopia at 4 months. Eight patients were treated for incidental basilar bifurcation aneurysms. One technical complication with no neurological deficit occurred in this group of patients with incidental aneurysms. Immediate angiographic results were considered to be satisfactory in 94% of patients, with complete obliteration in 42% and residual neck and dog ears in 52%. There was no bleeding episode after treatment during clinical follow-up periods ranging from 3 to 42 months (mean 15.5 months in 29 surviving patients). Angiographic results were available for 27 patients at 6 months and were as follows: 30% of the lesions were completely obliterated, 59% presented some residual neck, and 11% showed some opacification of the aneurysm sac. During the follow-up period of up to 42 months, a total of seven recurrences were noted, necessitating retreatment with GDCs in five patients. Endovascular treatment of basilar bifurcation aneurysms prevented rebleeding and could be performed without clinically significant complications in 94% of patients. Clinical results after SAH compared favorably with surgical series. Morphological results appear less satisfactory, and long-term angiographic follow-up review is mandatory to detect recurrences.

Operative Management of Foot and Ankle Equinovarus Associated with Focal Dystonia

1998 ◽  
Vol 19 (4) ◽  
pp. 229-231 ◽  
Author(s):  
Thomas J. Moore ◽  
William Evans ◽  
Douglas Murray
Keyword(s):  
Tendon Transfer ◽  
Operative Management ◽  
Clinical Results ◽  
Focal Dystonia ◽  
Functional Improvement ◽  
Foot And Ankle ◽  
Tendon Transfers ◽  
Anterior Tibial ◽  
Clinically Significant

Six surgical procedures, consisting of tendon transfers and releases, were performed in five patients with idiopathic focal dystonia involving the lower extremity. All patients were female. Surgical management was performed to correct clinically significant foot abnormalities. The goal of each procedure was functional improvement and obtaining a plantigrade foot. The SPLATT (split anterior tibial tendon transfer) procedure was performed in each foot with a flexible equinovarus foot abnormality. Follow up at a mean of 27.2 months (range, 8–40 months) yielded satisfactory clinical results without significant complications. Clinical equinovarus has not recurred after this procedure. All patients remain brace-free ambulators.

scholarly journals Prevention Across the Spectrum: a randomized controlled trial of three programs to reduce risk factors for both eating disorders and obesity

2014 ◽  
Vol 45 (9) ◽  
pp. 1811-1823 ◽  
Author(s):  
S. M. Wilksch ◽  
S. J. Paxton ◽  
S. M. Byrne ◽  
S.B. Austin ◽  
S. A. McLean ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Obesity Risk ◽  
Randomized Controlled ◽  
Obesity Risk Factors ◽  
Clinically Significant ◽  
Perceived Pressure

BackgroundA randomized controlled trial of three school-based programs and a no-intervention control group was conducted to evaluate their efficacy in reducing eating disorder and obesity risk factors.MethodA total of 1316 grade 7 and 8 girls and boys (mean age = 13.21 years) across three Australian states were randomly allocated to: Media Smart; Life Smart; the Helping, Encouraging, Listening and Protecting Peers (HELPP) initiative; or control (usual school class). Risk factors were measured at baseline, post-program (5 weeks later), and at the 6- and 12-month follow-ups.ResultsMedia Smart girls had half the rate of onset of clinically significant concerns about shape and weight than control girls at the 12-month follow-up. Media Smart and HELPP girls reported significantly lower weight and shape concern than Life Smart girls at the 12-month follow-up. Media Smart and control girls scored significantly lower than HELPP girls on eating concerns and perceived pressure at the 6-month follow-up. Media Smart and HELPP boys experienced significant benefit on media internalization compared with control boys and these were sustained at the 12-month follow-up in Media Smart boys. A group × time effect found that Media Smart participants reported more physical activity than control and HELPP participants at the 6-month follow-up, while a main effect for group found Media Smart participants reported less screen time than controls.ConclusionsMedia Smart was the only program to show benefit on both disordered eating and obesity risk factors. Whilst further investigations are indicated, this study suggests that this program is a promising approach to reducing risk factors for both problems.

scholarly journals The Effects of If-Then Plans on Weight Loss: Results of the 24-Month Follow-up of the McGill CHIP Healthy Weight Program Randomized Controlled Trial

2019 ◽  
Author(s):  
Barbel Knauper ◽  
huma shireen ◽  
Kimberly Carriere ◽  
Mallory Frayn ◽  
Elena Ivanova ◽  
...  
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Weight Loss Maintenance ◽  
Study Data ◽  
Average Weight ◽  
Healthy Weight ◽  
Clinically Significant

Abstract Background: The NIH-developed Diabetes Prevention Program (DPP) is successful in achieving clinically significant weight loss in individuals with overweight/obesity when delivered one-on-one. However, due to high cost of implementation, the long-term effectiveness remains limited. In response, a group-based version of the program, called the National DPP, was developed. The average weight loss following participation in this program was only about 3.5% with low long-term weight loss maintenance. Purpose: We aimed to optimize weight loss outcomes of the National DPP by integrating the habit formation tool of if-then plans into the program. Results at 3 and 12 months of participation showed no between-group differences between standard and enhanced DPP but higher weight loss in both groups compared to the National DPP. This paper reports the long-term weight loss maintenance data following participation in the program. Methods: Of the 172 participants enrolled at the beginning of the study, data from 110 participants was available and analyzed at 24 months, i.e. 12 months following the end of the 12-month intervention. Results: No between-group difference in weight loss maintenance was seen. Pooled results showed a significant weight regain from 12 to 24 months, i.e. an average of 7.85lbs of the 20.36lbs lost. However, participants from both groups were still 12.51lbs or 6.13% lighter at 24 months than at baseline. Conclusion: If-then plans did not result in a higher percentage of weight loss at 24-month follow-up. However, at 24 months, both groups maintained a significant portion of the weight lost at the end of intervention.

The Upper Airway Nasal Complex: Structural Contribution to Persistent Nasal Obstruction

2019 ◽  
Vol 161 (1) ◽  
pp. 171-177 ◽  
Author(s):  
Ryan Williams ◽  
Vishal Patel ◽  
Yu-Feng Chen ◽  
Navarat Tangbumrungtham ◽  
Andrew Thamboo ◽  
...  
Keyword(s):  
Nasal Obstruction ◽  
Hard Palate ◽  
Surgical Intervention ◽  
Upper Airway ◽  
Sinus Surgery ◽  
Control Group ◽  
Maxillary Expansion ◽  
Retrospective Case ◽  
Nasal Floor

Objective To determine the contribution of the nasal floor and hard palate morphology to nasal obstruction for nonresponders to prior intranasal surgery. Study Design Retrospective case-control study. Setting Tertiary academic center. Methods Institutional review board–approved, retrospective institutional database analysis was obtained of a cohort of 575 patients who presented with nasal obstruction over a 21-year period. Of the patients, 89 met inclusion criteria: 52 were placed into the experimental group, defined as having persistent nasal obstruction following endoscopic sinus surgery (ESS), septoplasty, nasal valve repair, and/or turbinoplasty using validated subjective questionnaires, and 37 were placed into the control group, defined as having resolution of subjective nasal obstruction. Computed tomography imaging was presented to 3 blinded experts, who measured numerous nasal airway and hard palate morphology parameters, including anterior nasal floor width, anterior maxillary angle, maxilla width, anterior nasal floor width, and palatal vault height. Standard demographic information, comorbidities, perioperative 22-item Sinonasal Outcome Test (SNOT-22), and follow-up time were also assessed. Wilcox rank sum analysis or t test was performed where appropriate. Results Follow-up ranged from 2 to 36 months following surgical intervention. Several skeletal characteristics within the upper airway were significantly associated with persistent nasal obstruction, including acute maxillary angle ( P = .035), narrow maxillary width ( P = .006), and high arched palate ( P = .004). Conclusion Persistent nasal obstruction may be seen in patients with narrow, high arched hard palate despite prior nasal surgical intervention and may benefit from additional skeletal remodeling procedures such as maxillary expansion.

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