Sensitivity treatments for teeth with Molar-Incisor Hypomineralization (MIH): Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Daniela Rios
Keyword(s):  
Clinical Trials ◽  
Sodium Fluoride ◽  
Pain Scale ◽  
Fluoride Varnish ◽  
Titanium Tetrafluoride ◽  
Group I ◽  
Molar Incisor Hypomineralization ◽  
Barrier Coat ◽  
Experimental Group

BACKGROUND The sensitivity of teeth with MIH (Molar Incisor Hypomineralization) can affect children’s quality of life and is a challenging problem for dentists. Remineralizing agents such as sodium fluoride varnish seem to reduce sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more consistent results about its effectiveness as a desensitizing agent before its clinical recommendation. OBJECTIVE This randomized clinical trial aims to compare three treatment interventions for teeth with MIH and hypersensitivity. METHODS : 60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel will be randomly assigned to three groups: Control group - sodium fluoride varnish (Duraphat®, Colgate); Experimental group I - 4% titanium tetrafluoride varnish (TiF4); and Experimental group II - coating resin containing S-PRG filler (Surface Pre-Reacted Glass ionomer) (SPRG Barrier Coat®, Shofu). The sodium fluoride varnish and 4% titanium tetrafluoride varnish will be applied once a week for 4 consecutive weeks and the S-PRG-Barrier Coat resin will be applied in the first session and the application will be simulated in the following 3 weeks to guarantee the blinding of the study. The primary outcome will be sensitivity level measured in different moments: before each material application, immediately after application or simulation, and 1, 2, 4, and 6 months after the last application/simulation by one examiner using Wong-Baker Facial Scale (WBFS), Schiff's Cold Air Sensitivity Scale (SCASS), and FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability pain scale). As secondary outcomes, the parental satisfaction and child self-reported discomfort after the treatment will be measured with a questionnaire prepared by the researcher. The data will undergo statistical analysis and the significance level will be set at 5%. RESULTS The project was funded in 2018, and enrollment was completed in November 2019. The recruitment of participants is currently under way and the first results are expected to be submitted for publication in 2022. CONCLUSIONS If found effective in reducing the patient’s sensitivity with long-term effects, these agents can be considered a treatment choice, and the findings will contribute with the development of a treatment protocol for teeth with sensitivity due to MIH. CLINICALTRIAL Brazilian Registry of Clinical Trials Universal Trial Number: U1111-1237-6720; http://www.ensaiosclinicos.gov.br/rg/?q=RBR-4BHXPB

scholarly journals CPP-ACP complexe as an alternative to treatment of incisor molar hypomineralization: case report

2019 ◽  
Vol 67 ◽  
Author(s):  
Micaela CARDOSO ◽  
Kelly Maria Silva MOREIRA ◽  
Andréia Alves CARDOSO ◽  
Regina Maria Puppin RONTANI
Keyword(s):  
Glass Ionomer Cement ◽  
Relative Sensitivity ◽  
Pain Scale ◽  
Fluoride Varnish ◽  
Thermal Stimulus ◽  
Tooth Structure ◽  
Mi Paste Plus ◽  
Molar Incisor Hypomineralization ◽  
Mi Paste ◽  
Brazilian Child

ABSTRACT The objective of this study was to report the clinical treatment of a child with Incisor Molar Hipomineralization. A 5-year-old Brazilian child, male gender, was diagnosed with Molar Incisor Hypomineralization, reporting high teeth sensitivity. After anamnesis and clinical examination, treatment was conducted with three weekly applications of fluoride varnish containing 5% CPP-ACP complex. Also, it was advice to the patient for using a toothpaste containing fluoride and CPP-ACP (MI Paste Plus). After that, molars with great tooth structure loss were restored with resin modified glass ionomer cement. Prior to the first topical application of varnish with CPP-ACP and fluoride toothpaste containing CPP-ACP, a sensitivity test was conducted using thermal stimulus and facial pain scale. It was observed relative sensitivity decrease between sessions, reporting no sensitivity at the last session before the restoration. The treatment of Molar Incisor Hypomineralization teeth with CPP-ACP complex associated with fluoride varnish can be an alternative to reduce sensivity.

scholarly journals Microleakage Assessment of Resin Infiltration Combined Restoration in Artificial Decalcified-Cavitated Lesion

2020 ◽  
Vol 47 (3) ◽  
pp. 257-265
Author(s):  
Eunjeong Jang ◽  
Soyoung Park ◽  
Jonghyun Shin ◽  
Shin Kim ◽  
Taesung Jeong
Keyword(s):  
Glass Ionomer Cement ◽  
Control Group ◽  
Resin Infiltration ◽  
Group I ◽  
Resin Modified Glass Ionomer ◽  
Group Ii ◽  
And Control ◽  
Caries Lesions ◽  
Experimental Group

This study was performed to evaluate the restoration combined with resin infiltration (RI) of early cavitated smooth surface caries lesion in terms of microleakage. Flowable resin and resin-modified glass ionomer cement (RMGIC) were compared.Sound 20 extracted 3rd molars were divided into 2 groups randomly. Artificial decalcified lesion was induced. Cavities were prepared on the mesial and distal surfaces, and randomly set as experimental and control group. RI was applied to the experimental group before cavity restoration. The control group was restored without RI. In group I and II, flowable resin and RMGIC was used for restoration respectively. After thermocycling and silver nitrate immersion, microleakage was assessed by μ-CT.Depth of microleakage was lower in experimental group than control group only in group II (p = 0.05). Microleakage depth was lower in group II than group I in both experimental and control groups (p = 0.05).RI pretreatment before restoration of early cavitated caries lesions might reduce the microleakage and help long-term maintenance of restoration. In this study, RMGIC was less polymerization shrinkage. Restoration with RMGIC after RI pretreatment reduced the microleakage of the restoration compared to the flowable resin.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

Comparative assessment of morphological mechanisms of maintaining structural liver homeostasis in the dynamics of exposure to coal-rock dust and sodium fluoride on the body

2020 ◽  
pp. 189-194
Author(s):  
M. S. Bugaeva ◽  
O. I. Bondarev ◽  
N. N. Mikhailova ◽  
L. G. Gorokhova
Keyword(s):  
Sodium Fluoride ◽  
Morphological Changes ◽  
The Body ◽  
System Level ◽  
Production Factor ◽  
Coal Rock ◽  
The Impact ◽  
Structural Homeostasis ◽  
Rock Dust

Introduction. The impact on the body of such factors of the production environment as coal-rock dust and fluorine compounds leads to certain shift s in strict indicators of homeostasis at the system level. Maintaining the relative constancy of the internal environment of the body is provided by the functional consistency of all organs and systems, the leading of which is the liver. Organ repair plays a crucial role in restoring the structure of genetic material and maintaining normal cell viability. When this mechanism is damaged, the compensatory capabilities of the organ are disrupted, homeostasis is disrupted at the cellular and organizational levels, and the development of the main pathological processes is noted.The aim of the study is to compare the morphological mechanisms of maintaining structural homeostasis of the liver in the dynamics of the impact on the body of coal-rock dust and sodium fluoride.Materials and methods. Experimental studies were conducted on adult white male laboratory rats. Features of morphological mechanisms for maintaining structural homeostasis of the liver in the dynamics of exposure to coal-rock dust and sodium fluoride were studied on experimental models of pneumoconiosis and fluoride intoxication. For histological examination in experimental animals, liver sampling was performed after 1, 3, 6, 9, 12 weeks of the experiment.Results. The specificity of morphological changes in the liver depending on the harmful production factor was revealed. It is shown that chronic exposure to coal-rock dust and sodium fluoride is characterized by the development of similar morphological changes in the liver and its vessels from the predominance of the initial compensatory-adaptive to pronounced violations of the stromal and parenchymal components. Long-term inhalation of coal-rock dust at 1–3 weeks of seeding triggers adaptive mechanisms in the liver in the form of increased functional activity of cells, formation of double-core hepatocytes, activation of immunocompetent cells and endotheliocytes, ensuring the preservation of the parenchyma and the general morphostructure of the organ until the 12th week of the experiment. Exposure to sodium fluoride leads to early disruption of liver compensatory mechanisms and the development of dystrophic changes in the parenchyma with the formation of necrosis foci as early as the 6th week of the experiment.Conclusions. The study of mechanisms for compensating the liver structure in conditions of long-term exposure to coal-rock dust and sodium fluoride, as well as processes that indicate their failure, and the timing of their occurrence, is of theoretical and practical importance for developing recommendations for the timely prevention and correction of pathological conditions developing in employees of the aluminum and coal industry.The authors declare no conflict of interests.

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

scholarly journals Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Matisyahu Shulman ◽  
Roger Weiss ◽  
John Rotrosen ◽  
Patricia Novo ◽  
Elizabeth Costello ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Extended Release ◽  
Primary Outcome ◽  
Opioid Use Disorder ◽  
Drug Abuse Treatment ◽  
Opioid Use ◽  
National Drug ◽  
Retention In Treatment ◽  
Abuse Treatment

AbstractOpioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.

scholarly journals Immune Check-Point Inhibitors and Standard Chemoradiotherapy in Definitive Head and Neck Cancer Treatment

2021 ◽  
Vol 11 (5) ◽  
pp. 393
Author(s):  
Francesca De Felice ◽  
Daniela Musio ◽  
Vincenzo Tombolini
Keyword(s):  
Clinical Trials ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Therapeutic Strategies ◽  
Check Point ◽  
Clinical Tool ◽  
Cancer Management ◽  
Check Point Inhibitors

In head and neck cancer management, there is a need for tailored approaches to optimally implement clinical outcomes. Based on the assumption that efficacy and long-term toxicity are not satisfactory for standard concurrent platinum-based chemoradiotherapy, several trials have been designed to test whether induction immunotherapy and/or concomitant immunotherapy and radiotherapy result in improved survival and toxicity outcomes. Here, we present an overview of the most recent concomitant therapeutic strategies for head and neck cancer, focusing on the knowledge available regarding check-point inhibitors. The aim is to present the characteristics of the main check-point inhibitors and to summarize the clinical trials on the combination of immune check-point inhibitors and (chemo)radiotherapy in the definitive HNC setting, in order to provide a useful clinical tool for further research.

scholarly journals Mitigative effect of Momordica cymbalaria fruit extract against sodium fluoride induced hepatotoxicity in Wistar male albino rats

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Raghavendra Mitta ◽  
Sushmitha Duddu ◽  
Raghuveer Yadav Pulala ◽  
Pradeepkumar Bhupalam ◽  
Venkatakirankumar Mandlem ◽  
...  
Keyword(s):  
Lipid Peroxidation ◽  
Blood Serum ◽  
Sodium Fluoride ◽  
Total Protein ◽  
Reduced Glutathione ◽  
Serum Biomarkers ◽  
Albino Rats ◽  
Serum Total Protein ◽  
Treatment Groups ◽  
Group I

AbstractObjectivesThe main objective of the present study is to evaluate the mitigative effect of hydroalcoholic extract of Momordica cymbalaria fruits against sodium fluoride (NaF) induced hepatotoxicity.MethodsIn this study, Wistar male albino rats were randomly divided into five groups of six rats each. Group I and II served as normal and toxic controls. Group III as plant control received extract at a dose of 400 mg/kg b. wt, p.o and Groups IV and V as treatment groups received extract at a dose 200 and 400 mg/kg b. wt, p.o for 30 days. All groups except Groups I and III received 100 ppm of NaF through drinking water. After completion of the study, blood collected for the estimation of liver blood serum biomarkers such as aspartate aminotransferases (AST), alanine aminotransferases (ALT), alkaline Phosphatase (ALP), direct and total bilirubin, total protein and albumin. The liver tissue homogenate was for estimation of lipid peroxidation, catalase, and reduced glutathione levels.ResultsThe results showed that NaF intoxication caused elevation of liver blood serum levels and lipid peroxidation; decreased levels of serum total protein, albumin and liver reduced glutathione, and catalase observed. The treatment groups showed decreased elevated serum biomarkers (ALT, AST, and ALP), liver lipid peroxidation and increased serum total protein and albumin, liver reduced glutathione and catalase levels in a dose-dependent manner. Histopathological studies also further strongly supported for mitigative effects of the plant.ConclusionsIn conclusion, our findings of the study indicated that M. cymbalaria fruits were a potential drug candidate in the treatment of NaF induced hepatotoxicity.

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