Pocock, S. J.: Clinical Trials — a practical approach. John Wiley &amp; Sons, Chichester — New York — Brisbane — Toronto — Singapore 1983, 265 S., £ 16.95

Enderlein, G.

doi:10.1002/bimj.4710270604

Cited by 22 publications

(14 citation statements)

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“…A sample size of 146 teeth was needed to detect a significant difference using 80% power and α = 0.05 (two-sided) [15,16], based on previously reported success rates of 80% and 95% for both CT (occlusal and approximal) and HT SSCs [3,17–20]. Assuming a dropout rate of 20% the size required the inclusion of 230 teeth.…”

Section: Methodsmentioning

confidence: 99%

A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan

et al. 2019

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Despite the high success rates of preformed metal crowns (PMCs) in children no randomized clinical trials compare methods of placement and none describe its use in Africa. Our aim was to compare survival and cost-effectiveness of PMCs placed by conventional techniques (CT) and biological Hall techniques (HT) using a prospective randomized control trial in a general dental practice from Khartoum. One hundred and nine and 103 PMCs were placed in randomly selected children (5-8years) with 1–2 carious primary molars using HT and CT respectively and followed for 2 years. Socioeconomic status, periodontal health, occlusion, anxiety, and procedure time were compared using student t-test. Kaplan–Meier survival rates and incremental cost effectiveness ratio (ICER) were compared between CT and HT. CT and HT groups were similar for age, gender, socio-economic status. Survival rates were high (over 90%) for both study arms and not statistically different (p>0.05). Anxiety scores were significantly higher in CT arm after 12 months compared to HT (p<0.001). Clinically, gingival and plaque indices were similar between groups (p>0.05) but occlusions were raised in nearly all subjects in the HT arm (p<0.05). Periodontal health improved, and occlusions adjusted over time in both arms. There were 3 (2.7%) and 6 (5.8%) minor failures, 7 (6.4%) and 6 (5.8%) major failures in HT and CT arms respectively. Mean procedure time was lower in HT (9.1 min) than CT (33.9 min); p<0.001. Mean PMC cost was US$2.45 and US$7.81 for HT and CT respectively. The ICER was US$136.56 more for each PMC placed by CT per life year. We show that PMCs have high survival outcomes in disadvantaged populations similar to results from developed countries. As HT can be carried out by less experienced dental operators and therapists, this biological approach provides a promising cost-effective option to manage caries in developing countries with limited resources. Trial registration: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT03640013

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Section: Methodsmentioning

confidence: 99%

A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan

et al. 2019

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“…Sampling was done in a non-probability sampling technique. Participants were allocated randomly to four groups according to stratification method [41, 42]. Stratification was done based on variables such as gender, BMI, baseline pain intensity, and frequency of attacks.…”

Section: Methodsmentioning

confidence: 99%

The Efficacy of Topical Basil Essential Oil on Relieving Migraine Headaches: A Randomized Triple-Blind Study

et al. 2020

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Objective: Complementary therapies have been increasingly used for the prevention and treatment of migraine so that there is a need for studies in this setting. This study sought to determine the effects of basil essential oil on the severity and frequency of migraine attack headaches. Methods: A triple-blind clinical trial study was performed on 144 patients diagnosed with migraine. Patients were randomly allocated by a stratified method to four groups of 36 titled basil essential oil 2, 4, 6%, and placebo groups. Medications were used topically every 8 h for 3 successive months. In addition, each individual received 325 mg of acetaminophen every 12 h. The severity and frequency of migraine attacks were measured prior to the study, at weeks 2, 4, 8, and 12. The visual analog scale was used to measure pain intensity. The marginal model and generalized estimation equations were used to compare changes in the intensity and frequency of pain over time. Results: The interaction of the dose and time factors was significant on both pain intensity (p < 0.001) and frequency of attack (p < 0.001). The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time. Conclusion: Time lapse and higher doses of basil essential oil would reduce both the intensity and frequency of migraine attacks.

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“…To get 80% power in the study with 5% acceptance for type 1 error, number of subjects were calculated based on statistical method for qualitative outcome 10. The p 1 value was defined as zero (proportion of the control expected to be more than zero), since subjects act as their own control.…”

Section: Methodsmentioning

confidence: 99%

Stability of thromboxane in blood samples

Helgadóttir¹,

Ólafsson²,

Andersen³

et al. 2019

VHRM

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Introduction: Conventional venous blood collection requires a puncture with a needle through the endothelium of a vessel. The endothelial injury causes activation of circulating platelets and the release of thromboxane A 2 . The aim of the study was to investigate if platelets continue to form thromboxane A 2 in the blood tube after sample collection, but such synthesis would give false information about the actual circulating thromboxane A 2 value. Methods: Thromboxane B 2 is a biologically inactive but stable metabolite of thromboxane A 2 and can be measured in blood samples by a standard enzyme immunoassay. Thromboxane B 2 measurements reflect thromboxane A 2 concentration. Blood samples were collected in 3.2% sodium citrate vials and EDTA vials from ten individuals and centrifuged and frozen at different time points (0, 30, and 120 minutes). Plasma aliquots were transferred to and frozen in 1.8 mL polypropylene tubes and the citrate samples were also transferred to and frozen in propylene tubes containing indomethacin. Results: Concentrations of thromboxane B 2 in plasma samples collected in citrate vials and stored in propylene tubes increased very rapidly as the samples were left for longer after sampling and allowed to stand at room temperature. After 120 minutes, the amount of thromboxane B 2 was 400% higher than in the reference sample at time zero. In comparison, thromboxane B 2 concentration was about 200% higher in the 120-minute samples compared to the reference in samples collected in citrate vials but stored in indomethacin tubes. In samples collected in EDTA vials, a 10% reduction in thromboxane B 2 concentration in the 120-minute samples was observed. Conclusion: Storage conditions, type of sampling vial and time from sampling until sample processing (centrifuging) has a major impact on thromboxane B 2 stability.

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Pocock, S. J.: Clinical Trials — a practical approach. John Wiley & Sons, Chichester — New York — Brisbane — Toronto — Singapore 1983, 265 S., £ 16.95

Cited by 22 publications

References 0 publications

A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan

A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan

The Efficacy of Topical Basil Essential Oil on Relieving Migraine Headaches: A Randomized Triple-Blind Study

<p>Stability of thromboxane in blood samples</p>

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