scholarly journals Clinical efficacy of nanohydroxyapatite-containing toothpaste at relieving dentin hypersensitivity: an 8 weeks randomized control trial

BDJ Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Bennett Tochukwu Amaechi ◽  
Kelly C. Lemke ◽  
Shyamali Saha ◽  
Minh N. Luong ◽  
Jonathan Gelfond
Keyword(s):  
Mixed Model ◽  
Potassium Nitrate ◽  
Post Treatment ◽  
Dentin Hypersensitivity ◽  
Double Blind ◽  
Mixed Model Analysis ◽  
Random Intercept ◽  
Parallel Group ◽  
Randomized Control ◽  
Time Point

Abstract Objective The objective of this study was to investigate and compare the effectiveness of several toothpastes containing nanohydroxyapatite (nano-HAP) to relieve dentin hypersensitivity (DHS) with that of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (CSPS). Materials and methods In this double-blind, randomized, parallel-group clinical trial, patients diagnosed with DHS and qualified to participate were randomized into four groups: toothpaste containing 10% nano-HAP (10%nano-HAP), 15% nano-HAP (15%nano-HAP), 10% nano-HAP supplemented with potassium nitrate (KNO3) (10%nano-HAPKN), or CSPS. Subjects’ baseline and post-treatment sensitivities were assessed using visual analog scale (VAS) after the application of ice-cold and air stimuli. Subjects used their assigned toothpaste for routine toothbrushing twice daily. Post-treatment sensitivity was assessed every 2 or 8 weeks. Mean change in VAS (mm) from baseline at each time point were compared using random-intercept, mixed-model analysis and Duncan test (P < 0.05). Results With either air or cold stimulus, VAS indicated a significant (P < 0.001) reduction from baseline DHS at each time point with all test toothpastes. Among the nano-HAP toothpastes, 15%nano-HAP and 10%nano-HAPKN were consistent in DHS reduction with both stimuli. With either stimuli, the CSPS did not significantly differ from 15%nano-HAP and 10%nano-HAPKN at any time point. Conclusions Toothpaste containing nano-HAP (10 or 15%) alone or supplemented with KNO3 was as effective as CSPS for relief of DHS symptoms when used at least twice daily.

scholarly journals Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-containing Cream: A Randomized Controlled Trial

2018 ◽  
Vol 12 (1) ◽  
pp. 572-585 ◽  
Author(s):  
Bennett T. Amaechi ◽  
Kelly C. Lemke ◽  
Shyamali Saha ◽  
Jonathan Gelfond
Keyword(s):  
Controlled Trial ◽  
Pain Scale ◽  
Positive Control ◽  
Dentin Hypersensitivity ◽  
Double Blind ◽  
Pure Silica ◽  
Parallel Group ◽  
Pain Scales ◽  
Significant Difference ◽  
Time Point

Objective:The study aimed to investigate the effectiveness of Apadent Pro (Sangi) Nanohydroxyapatite (nHAP) dental cream to relieve Dentin Hypersensitivity (DHS), compared with a positive control cream containing 20% pure silica (Silica).Methods:In this double-blind, randomized, parallel-group clinical trial, patients diagnosed with DHS and qualified to participate were randomized into two groups, nHAP (n=25) and Silica (n=26). Subjects’ baseline and posttreatment sensitivity were assessed using two pain scales, a four-point Dental Pain Scale (DPS) followed by a linear Visual Analog Scale (VAS), after the application of ice-cold and air stimuli. Subjects used custom-fabricated trays to apply their respective cream for 5 minutes once daily following brushing with standard fluoride toothpaste. Posttreatment sensitivity (efficacy) was assessed every 2 weeks for 8 weeks. Mean treatment outcomes (percentage change from baseline) at each time point were compared using the Tukey HSD test for multiplicity (P<0.05).Results:With either air or cold stimulus, VAS and DPS indicated a significant (P<0.001) reduction in DHS at each time point with either nHAP or Silica. Comparing pain scales, VAS showed no significant difference in DHS reduction between the products with either air or cold. However, with DPS, DHS reduction was significantly (P<0.05) better with Silica than with nHAP at all time points with cold, and at 2, 4, and 8 weeks with air.Conclusion:Both Apadent Pro nHAP and Silica dental creams are effective at promoting the relief of DHS symptoms. When comparing the efficacy of the two compounds to relieve DHS, results of the two pain scales were conflicting.

scholarly journals Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Brian R. Leaker ◽  
Dave Singh ◽  
Sam Lindgren ◽  
Gun Almqvist ◽  
Leif Eriksson ◽  
...  
Keyword(s):  
Immune System ◽  
Allergic Asthma ◽  
Allergen Challenge ◽  
Forced Expiratory Volume ◽  
Post Treatment ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Significant Difference ◽  
Th2 Responses

Abstract Background Although allergic asthma is a complex area with many interacting factors involved, the ‘hygiene hypothesis’ proposes that a lack of exposure to infection during childhood may polarise the immune system towards allergen-reactive Th2-type responses in genetically susceptible individuals. Toll-like receptors (TLRs) play a key role within the innate immune system and TLR7 agonists have previously been shown to up-regulate Th1 responses and down-regulate Th2 responses to allergens in murine models of allergic or chronic asthma. This study aimed to examine the efficacy and safety of the novel TRL7 agonist AZD8848, which has been developed as an antedrug. Methods In this double-blind, randomised, parallel-group study, AZD8848 60 μg or placebo was administered intranasally once-weekly for 8 weeks in patients with mild-to-moderate allergic asthma (NCT00999466). Efficacy assessments were performed at 1 and 4 weeks after the last dose. The primary outcome was the late asthmatic response (LAR) fall in forced expiratory volume in 1 s (FEV1) after allergen challenge at 1-week post-treatment. Results AZD8848 significantly reduced average LAR fall in FEV1 by 27% vs. placebo at 1 week after treatment (p = 0.035). This effect was sustained at 4 weeks post-treatment; however, it did not reach clinical significance. AZD8848 reduced post-allergen challenge methacholine-induced airway hyper-responsiveness (AHR) vs. placebo at 1 week post-dosing (treatment ratio: 2.20, p = 0.024), with no effect at 4 weeks. There was no significant difference between the two groups in plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge at 1 week after treatment. The incidence of adverse events was similar in the two groups. AZD8848 was generally well tolerated. Conclusions and clinical relevance In patients with allergic asthma, TLR7 agonists could potentially reduce allergen responsiveness by stimulating Type 1 interferon responses to down-regulate the dominant Th2 responses. Trial registration clinicaltrials.gov identifier NCT00999466.

scholarly journals Acute memory and psychotomimetic effects of cannabis and tobacco both ‘joint’ and individually: a placebo-controlled trial

2017 ◽  
Vol 47 (15) ◽  
pp. 2708-2719 ◽  
Author(s):  
C. Hindocha ◽  
T. P. Freeman ◽  
J. X. Xia ◽  
N. D. C. Shaban ◽  
H. V. Curran
Keyword(s):  
Verbal Memory ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Subjective Effects ◽  
Preliminary Evidence ◽  
Interactive Effects ◽  
Double Blind ◽  
Mixed Model Analysis ◽  
Psychotomimetic Effects

BackgroundCannabis and tobacco have contrasting cognitive effects. Smoking cannabis with tobacco is prevalent in many countries and although this may well influence cognitive and mental health outcomes, the possibility has rarely been investigated in human experimental psychopharmacological research.MethodThe individual and interactive effects of cannabis and tobacco were evaluated in 24 non-dependent cannabis and tobacco smokers in a randomized, placebo-controlled, double-blind, 2 (cannabis, placebo) × 2 (tobacco, placebo) crossover design. Verbal memory (prose recall), working memory (WM) performance including maintenance, manipulation and attention (N-back), psychotomimetic, subjective and cardiovascular measures were recorded on each of four sessions.ResultsCannabis alone impaired verbal memory. A priori contrasts indicated that tobacco offset the effects of cannabis on delayed recall. However, this was not supported by linear mixed model analysis. Cannabis load-dependently impaired WM. By contrast, tobacco improved WM across all load levels. The acute psychotomimetic effects and ratings of ‘stoned’ and ‘dizzy’ induced by cannabis were not altered by tobacco. Cannabis and tobacco had independent effects on increasing heart rate and interacting effects on increasing diastolic blood pressure.ConclusionsRelative to placebo, acute cannabis impaired verbal memory and WM. Tobacco enhanced performance on WM, independently of cannabis. Moreover, we found some preliminary evidence that tobacco may offset the effects of cannabis on delayed, but not immediate, verbal recall. In contrast, the psychotomimetic and subjective effects of cannabis were unaffected by tobacco co-administration. By reducing the cognitive impairment from cannabis, tobacco co-administration may perpetuate use despite adverse health consequences.

scholarly journals Methylphenidate-Related Improvements in Math Performance Cannot Be Explained by Better Cognitive Functioning or Higher Academic Motivation: Evidence From a Randomized Controlled Trial

2017 ◽  
Vol 24 (13) ◽  
pp. 1824-1835 ◽  
Author(s):  
Anne Fleur Kortekaas-Rijlaarsdam ◽  
Marjolein Luman ◽  
Edmund Sonuga-Barke ◽  
Pierre Bet ◽  
Jaap Oosterlaan
Keyword(s):  
Cognitive Functioning ◽  
Academic Motivation ◽  
Mixed Model ◽  
Controlled Trial ◽  
Perceived Competence ◽  
Math Performance ◽  
Adhd Group ◽  
Interference Control ◽  
Double Blind ◽  
Mixed Model Analysis

Objective: This study investigated whether improvements in working memory, reaction time, lapses of attention, interference control, academic motivation, and perceived competence mediated effects of methylphenidate on math performance. Method: Sixty-three children (ADHD diagnosis; methylphenidate treatment; age 8-13; IQ > 70) were randomly allocated to a 7-day methylphenidate or placebo treatment in this double-blind placebo-controlled crossover study and compared with 67 controls. Data were collected at schools and analyzed using mixed-model analysis. Methylphenidate was hypothesized to improve all measures; all measures were evaluated as potential mediators of methylphenidate-related math improvements. Results: Controls mostly outperformed the ADHD group. Methylphenidate did not affect measures of cognitive functioning ( p = .082-.641) or academic motivation ( p = .199-.865). Methylphenidate improved parent ratings of their child’s self-perceived competence ( p < .01), which mediated methylphenidate efficacy on math productivity. Conclusion: These results question the necessity of improvements in specific cognitive and motivational deficits associated with ADHD for medication-related academic improvement. They also stimulate further study of perceived competence as a mediator.

scholarly journals model-based radiostereometric analysis (RSA) randomized control trial evaluating the stability of the cementless Taperloc hip stem: the TapHip study

2022 ◽  
pp. 212-221
Author(s):  
Ruben Y Kok ◽  
Lennard A Koster ◽  
Bart L Kaptein ◽  
Marta Fiocco ◽  
Stefan B Keizer
Keyword(s):  
Mixed Model ◽  
Radiostereometric Analysis ◽  
Mixed Model Analysis ◽  
Cementless Total Hip Arthroplasty ◽  
Model Based ◽  
Design Changes ◽  
Full Profile ◽  
Randomized Control ◽  
The Stability

Background and purpose – The Taperloc Complete hip is the successor of the Taperloc hip, aiming to increase range of motion and optimizing femoral fit with intermediate stem sizes. We evaluated whether these design changes affect fixation, and this RSA study compares 2-year migration. Patients and methods – In this prospective, multi-arm study, 100 patients were randomized to cementless total hip arthroplasty (THA) with Taperloc Complete full profile (TCFP), Taperloc Complete reduced distal (TCRD), Taperloc full profile (TFP), or Taperloc reduced distal (TRD). Migration was measured with model-based RSA postoperatively, and after 3, 12, and 24 months. Results – Results based on mixed-model analysis on 2-year postoperative RSA data from 74 patients showed similar subsidence (mm) in the first 3 months (mean [95% CI] TCFP 0.44 [0.20–0.69], TCRD 0.91 [0.40–1.42], TFP 0.71 [0.22–1.19], TRD 1.25 [0.58–1.91]) and stabilization afterwards. The TCFP showed statistically significantly less retroversion (°) at 2-year postoperatively compared with TFP and TCRD (mean [95% CI] TCFP: –0.13 [–0.64 to 0.38], TCRD: 0.84 [0.35–1.33], TFP: 0.56 [0.12–1.00], TRD: 0.37 [–0.35 to 1.09]). Interpretation – As expected in successful cementless THA, RSA shows stabilization after initial subsidence. Based on these results the Taperloc Complete stem is expected to have similar long-term fixation to the Taperloc stems. The reduced distal groups have larger, but statistically non-significant, initial migration compared with the TCFP group, which could be due to implantation in Dorr B, C femur types. It may be important to consider the femur shape for choosing a full profile or reduced distal stem to minimize migration.

scholarly journals No Relation between Therapeutic Response to Methylphenidate and its Cardiovascular Side Effects in Children with Attention-Deficit/Hyperactivity Disorder

2008 ◽  
Vol 1 ◽  
pp. CMPed.S1010
Author(s):  
Venkataramana Bhat ◽  
Natalie Grizenko ◽  
Steven Sanche ◽  
Ridha Joober
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Mixed Model ◽  
Therapeutic Response ◽  
Double Blind ◽  
Mixed Model Analysis ◽  
Hyperactivity Disorder ◽  
Cardiovascular Side Effects ◽  
Response Groups ◽  
Underlying Mechanisms

Objective The aim of this study was to examine the relation between therapeutic response to methylphenidate (MPH) and its associated short term cardiovascular side effects (Systolic Blood Pressure-SBP, Diastolic Blood Pressure-DBP and Heart Rate-HR changes) in children with ADHD, based on the hypothesis that these parameters share common underlying mechanisms. Method A double-blind placebo-controlled crossover clinical trial of children 6 to 12 years old diagnosed with ADHD was done. The children were given one week of 0.5 mg/kg MPH and one week of placebo (divided into two equal doses, given twice every day). On the morning of the third day of each week, Blood Pressure (BP) and HR were recorded immediately before (at time 0) and after (at time 10 and 45 minutes) administration of MPH. Children were grouped into 4 categories according to their therapeutic response (large, moderate, mild or no response) to MPH. A mixed model analysis of variance was performed to determine whether response groups were different with regard to cardiovascular side effects. Results All variables were comparable among the four groups 10 min after treatment with MPH and with placebo. Small but significant (p < 0.001) increases were seen in SBP (3.65 mm of Hg) and DBP (3.99 mm of Hg) 45 minutes after administration of MPH. A small but significant decrease in HR (3.3 beats per minute) was observed 45 min after administration of placebo. No significant differences in SBP, DBP and HR were found between response groups. Conclusions MPH causes a small but significant change in BP at 45 minutes after administration. No changes in HR were observed with MPH at 45 minutes. Responders to MPH treatment do not differ from non-responders in occurrence of BP and HR changes, at least within 45 minutes after administration and with the MPH dosage used in the study.

scholarly journals Playing to live: outcome evaluation of a community-based psychosocial expressive arts program for children during the Liberian Ebola epidemic

2019 ◽  
Vol 6 ◽  
Author(s):  
C. A Decosimo ◽  
J. Hanson ◽  
M. Quinn ◽  
P. Badu ◽  
E. G. Smith
Keyword(s):  
Treatment Group ◽  
Mixed Model ◽  
Outcome Evaluation ◽  
Post Treatment ◽  
Post Intervention ◽  
Mixed Model Analysis ◽  
Significant Difference ◽  
Post Test ◽  
Group 2 ◽  
Over Time

Background.This paper reviews the efficacy of a community psychosocial arts program focused on building mental health capacity within post-Ebola Liberia. The aim of this paper was to evaluate the outcome effects of two groups using pre- and post-treatment data. We hypothesized that there would be a difference in symptoms pre- and post-treatment, and the longer program would yield more significant results.Methods.There was a total of 870 child participants. Of 40 sites, 24 were selected for a 5-month treatment (TG1) while the remaining 16 sites received 3 months of treatment (TG2). Pairedttests and a mixed-model analysis of variance (ANOVA) were used to analyse pre- and post-psychological stress symptoms (PSS) for samples from both groups.Results.Separately, treatment group 1 (TG1) and treatment group 2's (TG2) pairedttest yielded significant results (p< 0.001) for the decrease of PSS. The mixed-model ANOVA found that there were significant differences in total pre- and post-test PSS and a significant difference in PSS means over time.Conclusions.Results indicated that there was a statistically significant decrease in reported symptoms in both treatment groups pre- to post-intervention and a significant difference in total symptoms over time. However, the findings do not indicate that the longer programming was statistically different compared to the shorter programming. The study presented had gaps in data, largely due to limits in research during the crisis. However, this paper provides a unique case study for challenges that can be faced for project evaluation in emergency settings.

scholarly journals A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016843 ◽  
Author(s):  
Lucio Marinelli ◽  
Maurizio Balestrino ◽  
Laura Mori ◽  
Luca Puce ◽  
Gian Marco Rosa ◽  
...  
Keyword(s):  
Stretch Reflex ◽  
Rating Scales ◽  
Mixed Model ◽  
Rating Scale ◽  
Wilcoxon Test ◽  
Bladder Function ◽  
Monosynaptic Reflex ◽  
Double Blind ◽  
Mixed Model Analysis ◽  
Increased Risk

IntroductionStroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring.Methods and analysisWe will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment).Ethics and disseminationThe study was registered on the EudraCT database with number 2016-001034-10 and approved by both the Italian Medicines Agency (Agenzia Italiana del Farmaco) and local Ethics Committee ‘Comitato Etico Regionale della Liguria’. Data will be made anonymous and uploaded to a open access repository. Results will be disseminated by presentations at national and international conferences and by publication in journals of clinical neuroscience and neurology.

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