scholarly journals Efficacy of P11-4 for the treatment of initial buccal caries: a randomized clinical trial

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Paulina Sedlakova Kondelova ◽  
Alaa Mannaa ◽  
Claudine Bommer ◽  
Marwa Abdelaziz ◽  
Laurent Daeniker ◽  
...  
Keyword(s):  
Sequential Design ◽  
Fluoride Varnish ◽  
Placebo Control ◽  
White Spot Lesions ◽  
Safety And Efficacy ◽  
Hierarchical Linear Modelling ◽  
Randomized Controlled ◽  
Self Assembling ◽  
Significant Difference ◽  
Linear Modelling

AbstractTo investigate the safety and efficacy of Self-Assembling Peptide P11-4 (SAP P11-4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P11-4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P11-4 lesions (test, D90–D0) showed significant WSL size reduction compared to placebo (control, D90–D0; p = 0.008) or FV (control, D180–D90; p = 0.001). Combination of SAP P11-4 and delayed FV after 90 days (test, D180–D0), showed a significant difference compared to FV alone (control D270–D90; p = 0.003). No significant difference on FV efficacy was found when SAP P11-4 was applied 3 months before FV (test D270–D90; control D270–D90, p = 0.70). SAP P11-4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P11-4. SAP P11-4 was found to be a safe and effective WSL treatment.

Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial

2019 ◽  
Vol 42 (3) ◽  
pp. 326-330 ◽  
Author(s):  
Mikael Sonesson ◽  
Anna Brechter ◽  
Salem Abdulraheem ◽  
Rolf Lindman ◽  
Svante Twetman
Keyword(s):  
Placebo Group ◽  
Orthodontic Treatment ◽  
Test Group ◽  
Ammonium Fluoride ◽  
Dropout Rate ◽  
White Spot ◽  
Fluoride Varnish ◽  
White Spot Lesions ◽  
Randomized Controlled ◽  
Fixed Appliances

Summary Background Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances. Objective To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment. Subjects and methods The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12–18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score. Results One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL’s on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1. Limitations The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out. Conclusions Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances. Clinical trial registration ClinicalTrials.gov (NCT03725020). Protocol The protocol was not published before trial commencement.

scholarly journals Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Anahita Jablonski-Momeni ◽  
R. Nothelfer ◽  
M. Morawietz ◽  
A. Kiesow ◽  
H. Korbmacher-Steiner
Keyword(s):  
Orthodontic Brackets ◽  
Fluoride Varnish ◽  
White Spot Lesions ◽  
Single Application ◽  
Group Iii ◽  
Self Assembling ◽  
Group I ◽  
Human Enamel ◽  
Fixed Appliances ◽  
Group Ii

Abstract Enamel demineralisation can occur as a side effect during orthodontic treatment with fixed appliances. This study aimed to evaluate the efficacy of the self-assembling peptide P11-4 for remineralisation combined with fluorides, compared to application of fluoride varnish alone. De- and remineralisation was assessed by Quantitative light-induced fluorescence (QLF). Orthodontic brackets were bonded on 108 human enamel samples and white spot lesions were created. The samples were allocated randomly into three groups: Group I received no treatment, group II had a single application of fluoride varnish (22,600 ppm), and group III was treated with P11-4 following a single application of fluoride varnish. Quantitative light-induced fluorescence (QLF) measurements were performed at baseline, after demineralisation and after storage in remineralisation solution for 7 and 30 days. Non-parametric tests (Kruskal–Wallis test and Friedman test) were used for further analysis. After demineralisation, all samples showed a median ΔF -9.38% ± 2.79. After 30 days median ΔF values were as followed: group I = -9.04% ± 2.51, group II = -7.89 ± 2.07, group III = -6.08% ± 2.79). The median ΔF values differed significantly between all groups at all investigation times (p < 0.00001). Application of P11-4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.

scholarly journals Safety of Denosumab Versus Zoledronic Acid in Patients with Bone-related Diseases A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Wenhao Luo ◽  
Ye Li
Keyword(s):  
Adverse Events ◽  
Web Of Science ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Skeletal Related Events ◽  
Better Than

IntroductionBoth Dmab and ZA have been widely used in the prevention and treatment of bone-related diseases, while which drug is an optimal treatment in terms of safety and efficacy remains controversial.Material and methodsPubMed, Embase, Web of Science, the Cochrane Central Library, and ClinicalTrials.gov were systematically searched up to 1st January 2021, and were evaluated by Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. Randomized controlled trials comparing Dmab versus ZA in patients with bone-related diseases were included.ResultsA total of 13 studies involving 21042 participants were included. The incidence of total adverse events was significantly lower in patients receiving Dmab treatment than in those undergoing ZA treatment(OR= 0.84, 95% CI = 0.75–0.94, P = 0.003). 9 trials comparing Dmab with ZA further showed that Dmab was significantly better than ZA in controlling serious adverse events (OR = 0.91, 95% CI = 0.85–0.99, P = 0.02). Compared to ZA, Dmab was correlated with a lower incidence of skeletal-related events (OR = 0.77, 95% CI = 0.70–0.85, P = 0.00001). However, no significant difference was found in the rate of infection events between Dmab and ZA (OR = 1.06, 95% CI = 0.93–1.20, P =0.39).ConclusionsThis study demonstrated superiority of Dmab over ZA in treating bone-related diseases in terms of safety and efficacy.

Placebo Cure Rates in the Treatment of Onychomycosis

2014 ◽  
Vol 104 (3) ◽  
pp. 277-282 ◽  
Author(s):  
Aditya K. Gupta ◽  
Maryse Paquet
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Placebo Control ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Pubmed Database ◽  
Significant Difference ◽  
Study Characteristics ◽  
Design Characteristics ◽  
Cure Rates

Placebo cure rates vary among randomized clinical trials for onychomycosis, but the factors influencing these cure rates have not been systematically investigated. The PubMed database and reference sections of relevant publications were searched for randomized controlled trials of dermatophyte toenail onychomycosis that included a placebo control and that assessed cure rates. From 21 studies, the pooled mean ± SD placebo cure rates regarding mycological, clinical, and complete cure were 8.7% ± 3.7%, 3.4% ± 2.2%, and 1.2% ± 1.4%, respectively. There was no statistically significant difference between oral and topical treatments. None of the cure rates significantly correlated with any of the participant or study design characteristics analyzed. Placebo cure rates in randomized controlled trials of toenail onychomycosis are relatively low and are independent of the study characteristics.

scholarly journals Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

2021 ◽  
Author(s):  
Qingwei Li ◽  
Haiyin Zhang ◽  
Guozhen Lin ◽  
Shenxun Shi ◽  
Yingli Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Overall Response Rate ◽  
Response Rate ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
High Dose ◽  
Safety And Efficacy ◽  
Overall Response ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background This study aimed to determine the safety and efficacy of different doses of tandospirone to treat generalized anxiety disorder (GAD). Methods This parallel randomized controlled trial involved patients with GAD from eight centers in China between 01/2012 and 09/2018. Patients were randomly assigned to 60 mg/day and 30 mg/day groups. The primary endpoint was the overall response rate at the end of week 6. The secondary endpoints included significant response rate, change in Hamilton Anxiety Scale (HAMA) total score, HAMA subscale score, Hamilton Depression Scale-17 (HAMD-17), and adverse drug reactions. Results No significant difference was found in the overall response rate (65.7% vs 58.4%, P > 0.05) between 60 mg/day and 30 mg/day groups. The significant response rate (34.3% vs 22.6%, P = 0.032) was better in the 60 mg/day group. The reduction in HAMA total score, somatic anxiety factor, cardiovascular symptom factor, gastrointestinal symptom factor, and HAMD-17 score were better in the 60 mg/day group (all P < 0.05). The incidence of dizziness and gastrointestinal reactions of the 60 mg/day group was higher than that of the 30 mg/day group. However, there was no significant difference in the proportion of withdrawal due to adverse events. Conclusions For GAD treatment, the overall response rate of high-dose tandospirone was similar to that of low-dose tandospirone. The safety in the two groups was tolerable. Patients with good compliance might benefit from a high-dose regimen. Trial registration: The trial registration no. was NCT01614041(07/06/2012).

scholarly journals Potential Immuno-modulatory activity of Probiotics containing Lactobacillusacidophilus and Lacobacilluscasei to increase the ratio of IFN γ/IL-4 in patients with Allergic Rhinitis

2018 ◽  
Vol 18 (1) ◽  
pp. 42-45
Author(s):  
Andriana Tjitria Widi Wardani ◽  
Wiratno ◽  
Dina Fatmawati
Keyword(s):  
Allergic Rhinitis ◽  
Medical Science ◽  
Control Group ◽  
Placebo Control ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Ifn Γ ◽  
And Control ◽  
Single Blind

Aims: This study aimed to determine the effect of probiotic combination on ratio of IFN-γ: IL-4 levels in patients with allergic rhinitis. Materials and methods: Single blind, randomized controlled trial.This study included 40 patients with severe allergic rhinitis according to WHO criteria. This study used 2 treatment groups with probiotics and placebo control group. IFN γ and IL-4 levels were evaluated using ELISA method. Data were analyzed using paired T test with 95% confidence intervals Results and Discussion: In the treatment group, the levels of IFN-γ increased significantly (p<0.05).In contrast, IL-4 levels decreased significantly(p<0.05). There was a significant difference between the IFN-γ ratio: IL-4 treatment and control group (p <0.05). Conclusion: The administration of combination of probiotics can improve the levels of IFN-γ/ IL-4 in patients with moderate to severe allergic rhinitis. Bangladesh Journal of Medical Science Vol.18(1) 2019 p.42-45

scholarly journals Intravenous Ibuprofen 400 Versus 800 mg Every 6 Hours in Abdominal and Orthopedic Surgery: A Multicenter, Randomized Controlled Trial

2021 ◽  
Author(s):  
Hong Zhang ◽  
Ji-Han Huang ◽  
Hong-Meng Xu ◽  
Li Chen ◽  
Hong Zheng ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Orthopedic Surgery ◽  
Chinese Population ◽  
Morphine Consumption ◽  
Placebo Control ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Intravenous Ibuprofen

Abstract Background: Multimodal postoperative analgesia with intravenous ibuprofen can reduce the consumption of opioids and reduce the postoperative pain intensity. Recommended dose in the USA and Europe is 800 mg every 6 hours for the management of moderate to severe postoperative pain. The purpose of this study was to investigate whether 800 mg is needed in the Chinese population.Methods: This is a multicenter, randomized, controlled multi-center trial. Adult patients (18-65 years of age) scheduled for abdominal or orthopedic surgery under general anesthesia with endotracheal intubation were eligible. Subjects were randomized at a ratio of 1:1:1 to receive ibuprofen at 400 or 800 mg or saline every 6 hours for 48 hours after the operation. All subjects received morphine access through patient-controlled intravenous analgesia (PCIA) device, which was set as background infusion rate 0.5 mg/h, bolus 1 mg, 5-minute lock interval and 20-mg 4-hour limit. The primary endpoint was morphine consumption within the first 24 hours after surgery. Results: A total of 396 patients were enrolled (180 men, 216 women; 46±12.4 years of age; 106 patients receiving abdominal surgery, and 290 patients receiving orthopedic surgery). The number of patients was 131 in the placebo group, 132 in the 400-mg group, and 133 in the 800-mg group. The 3 groups did not differ in age, sex, BMI and the type of surgery. Median 24-hour morphine consumption was 39.1 mg (IQR: 29.7, 61.7) mg in the placebo control, 29.8 mg (IQR: 24.3, 43.7) mg in the 400-mg group, and 28.0 mg (IQR: 24.1, 35.9) in the 800-mg group (P<0.001 for comparisons between placebo versus 400 and 800 mg ibuprofen). There was no significant difference between the two ibuprofen groups (P=0.125). Analgesia-related adverse events did not differ among the 3 groups.Conclusions: Intravenous ibuprofen at either 400 or 800 mg every 6 hours could reduce postoperative morphine consumption, with apparently equal efficacy in Chinese population.

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