Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Sodium Hexametaphosphate Dentifrice for Dental Hypersensitivity

2006 ◽  
Vol 7 (2) ◽  
pp. 1-8 ◽  
Author(s):  
Thomas Schiff ◽  
Tao He ◽  
Lisa Sagel ◽  
Robert Baker

Abstract Purpose Dentinal hypersensitivity is a common complaint among dental patients. Recently, a novel 0.454% stabilized stannous fluoride dentifrice containing sodium hexametaphosphate (SHMP) was introduced that offers a desensitizing benefit. This trial was conducted to assess the desensitizing efficacy of this new dentifrice relative to a sodium fluoride control dentifrice. Methods and Materials This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association (ADA) Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Ninety subjects who met the entrance criteria were stratified based on age, gender, and baseline sensitivity scores and randomly assigned to either the stabilized stannous fluoride + SHMP dentifrice (Crest® Pro-Health) or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for eight weeks. Efficacy assessments were made, including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity, and an oral soft tissue examination was conducted at baseline, week four, and week eight. Results The mean sensitivity score based on the Schiff Air Index for the stannous fluoride + SHMP group was statistically significantly lower than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had an adjusted mean 44% lower than that of the control group. The mean tactile sensitivity score for the stannous fluoride + SHMP group was statistically significantly higher, indicating a reduction in sensitivity, than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had a mean desensitizing improvement of 71% greater than the control. Conclusion The stabilized stannous fluoride + SHMP dentifrice provided statistically significant reductions in dentinal hypersensitivity at four and eight weeks compared to the sodium fluoride control dentifrice. Citation Schiff T, He T, Sagel L, Baker R. Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Sodium Hexametaphosphate Dentifrice for Dentinal Hypersensitivity. J Contemp Dent Pract 2006 May;(7)2:001-008.

2010 ◽  
Vol 11 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Tao He ◽  
Trevor Day ◽  
Johannes Einwag ◽  
Joachim S. Hermann ◽  
Mary Kay Anastasia ◽  
...  

Abstract Aim To measure the desensitizing benefits of an experimental stannous-containing sodium fluoride dentifrice versus a regular sodium fluoride negative control. Methods and Materials This study was a randomized, double-blind, parallel group, fourweek clinical trial. Subjects reporting dentinal hypersensitivity were enrolled and randomized to the experimental dentifrice or the control dentifrice to use twice daily for four weeks. Efficacy assessments (Air Blast) were performed at baseline and weeks two and four. Separate analyses were performed for the two most sensitive teeth at baseline and for all 12 teeth. Results for weeks two and four combined also were analyzed. Results Thirty-one subjects were included in the analyses. For the two most sensitive teeth, the experimental dentifrice showed statistically significantly less sensitivity (p<0.05) versus the control at weeks two and four and for weeks two and four combined. The sensitivity reduction ranged from 24.9% to 28.4% over the control. For all 12 teeth, the experimental group had statistically significantly (p<0.03) lower sensitivity scores versus the control group at week two and weeks two and four combined. Conclusion The experimental dentifrice demonstrated significant desensitizing advantages versus the control. Clinical Significance This stannouscontaining sodium fluoride dentifrice provides an effective treatment for patients with dentinal hypersensitivity, significantly reducing sensitivity versus a negative control in this four-week trial. Citation Day TN, Einwag J, Hermann JS, He T, Anastasia MK, Barker M, Zhang Y. A Clinical Assessment of the Efficacy of a Stannous- Containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity. J Contemp Dent Pract [Internet]. 2010 Jan; 11(1):001-008. Available from:http://www.thejcdp.com/journal/view/volume11- issue1-day.


2020 ◽  
Vol 24 (11) ◽  
pp. 4043-4049
Author(s):  
Chad J. Anderson ◽  
Gerard Kugel ◽  
Yuanshu Zou ◽  
Marco Ferrari ◽  
Robert Gerlach

Abstract Objectives To compare the effects of a stannous fluoride dentifrice and a sodium fluoride dentifrice on dentinal hypersensitivity when used with an oxalate-based regimen combining in-office and at-home treatment. Materials and methods In this single-center, randomized, controlled, double-blind, pilot clinical trial, 30 subjects were professionally treated at baseline with a 3% oxalate/potassium salt solution on up to two target teeth, then randomized 1:1 to either 0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice. Both groups were given 6 sensitivity strips (3.14% potassium oxalate gel) and a soft, manual toothbrush. Subjects were permitted to apply strips on up to two teeth, up to three times per tooth, at home as desired throughout the study. Dentinal sensitivity (cold air blast challenge) was assessed at baseline, immediately after post-professional treatment, and at day 60 using the Schiff scale and a Visual Analog Scale (VAS). Results Immediately after professional oxalate treatment, the overall mean Schiff and VAS score decreased 25.6% and 22.4% from baseline, respectively (p ≤ 0.001 for both). At day 60, further reductions in both mean scores were seen in both groups. There were no significant differences between the groups at day 60. All treatments were well tolerated. Conclusions In subjects treated with oxalates for dentinal hypersensitivity, both stannous fluoride and sodium fluoride dentifrices are well tolerated, are feasible for routine use, and do not detract from the desensitizing effects of an in-office and at-home oxalate combination treatment regimen. Clinical relevance Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.


2009 ◽  
Vol 10 (2) ◽  
pp. 1-9 ◽  
Author(s):  
Matthew L. Barker ◽  
Philip G. Bellamy ◽  
Nichelle Khera ◽  
Trevor N. Day ◽  
Andrew J. Mussett

Abstract Aim To compare the plaque inhibition efficacy of a sodium fluoride/potassium nitrate (NaF/KNO3 with 1450 ppm F) test dentifrice to a 0.454% stannous fluoride/sodium hexametaphosphate/sodium fluoride positive control dentifrice (SnF2/SHMP with 1450 ppm F). Methods and Materials Twenty-five subjects were randomized to a two-period, two-treatment, double blind crossover sequence using NaF/KNO3 (Sensodyne® ProNamel™ dentifrice) and SnF2/SHMP (blend-a-med®* EXPERT GUMS PROTECTION dentifrice). Each treatment was conducted with a standard manual toothbrush (Oral-B® P35 Indicator). Digital plaque image analysis (DPIA) was used on three consecutive days to evaluate: (a) overnight plaque formation (A.M. pre-brushing); (b) following 40 seconds of brushing with the test product (A.M. post-brushing); and (c) mid-afternoon (P.M.). Images were analysed using an objective computer algorithm to calculate the total area of visible plaque. A four-day washout period was instituted for the crossover phase. Results All 25 subjects completed the study. The SnF2/SHMP positive control dentifrice provided statistically significantly lower levels of plaque area coverage versus the NaF/KNO3 test dentifrice at each timepoint. For the SnF2/SHMP dentifrice, plaque coverage was 23.0% lower (p<0.0001) at A.M. pre-brushing, 17.3% (p=0.0163) lower at A.M. post-brushing, and 22.6% (p= 0.0004) lower at the P.M. measure relative to the NaF/KNO3 dentifrice. Conclusion The SnF2/SHMP dentifrice (blend-a-med® EXPERT GUMS PROTECTION) inhibits plaque regrowth both overnight and during the day to a significantly greater degree than the NaF/KNO3 dentifrice (Sensodyne® ProNamel™). Clinical Significance Dentists recommending an effective home use dentifrice for patients experiencing dentinal hypersensitivity and/or dental erosion may previously have needed to compromise on other key benefits, such as plaque control. blend-a-med® EXPERT GUMS PROTECTION is a dentifrice when integrated into an oral hygiene routine can provide a proven treatment for hypersensitivity, dental erosion, and a reduction in the regrowth of plaque. Citation Bellamy PG, Khera N, Day TN, Barker ML, Mussett AJ. A Randomized Clinical Trial to Compare Plaque Inhibition of a Sodium Fluoride/Potassium Nitrate Dentifrice versus a Stabilized Stannous Fluoride/ Sodium Hexametaphosphate Dentifrice. J Contemp Dent Pract 2009 March; (10)2:001-009. * Also branded Crest® and Ipana, depending on the country.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.


Author(s):  
Maryam Sadeghi ◽  
Naeimeh Moheb ◽  
Marziyeh Alivandi Vafa

Introduction: The aim of current paper was to compare the effectiveness of acceptance and commitment group therapy (ACT) and group cognitive therapy (GCT) on Alexithymia and marital boredom (MB) among women affected by marital infidelity in Mashhad. Method: This clinical trial was a double- blind study with a pretest-posttest design in which two intervention groups and one control group were investigated. The study performed on women who realized their spouse infidelity and referred to Azad University Counseling Center in Mashhad in 2018. The sample consisted of 30 women who were selected by purposive sampling and were randomly assigned to two intervention groups and a control group (n=10 per group). The intervention groups were put under ACT training (twelve 90-minute sessions) and GCT training (twelve 90-minute sessions), but the control group did not receive any intervention. Data was obtained by the Toronto Alexithymia Scale-20 and Pines Marital Boredom Scale and was analyzed by multivariate analysis of covariance with SPSS (version 22) software. Results: The results showed a significant reduction in the mean score of MB in the ACT group, also there was a significant reduction in the mean score of Alexithymia in the GCT group (P <0.05). So comparing both therapies, ACT was more influential on reducing marital boredom whereas GCT was more effective on reducing alexithymia. Conclusion: Although both intervention methods were effective on Alexithymia and Marital Boredom in women affected by marital infidelity, it was demonstrated that ACT and GCT have more effect on Marital Boredom and Alexithymia, respectively.


2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.


2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.


2018 ◽  
Vol 48 (4) ◽  
pp. 251-259 ◽  
Author(s):  
Jalal Azmandian ◽  
Mohammad Reza Abbasi ◽  
Vahid Pourfarziani ◽  
Amir Ahmad Nasiri ◽  
Shahrzad Ossareh ◽  
...  

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).


2020 ◽  
Vol 85 (5) ◽  
pp. 396-404
Author(s):  
Abolfazl Mehdizadehkashi ◽  
Kobra Tahermanesh ◽  
Samaneh Rokhgireh ◽  
Vahideh Astaraei ◽  
Zahra Najmi ◽  
...  

<b><i>Background and Objectives:</i></b> A tourniquet has been suggested as a useful means of reducing massive hemorrhage during myomectomy. However, it is not clear whether the restricted perfusion affects the ovaries. In the present study, we examined the effect of a tourniquet on ovarian reserve and blood loss during myomectomy. <b><i>Materials and Methods:</i></b> In a randomized double-blind clinical trial, fertile nonobese patients scheduled for abdominal myomectomy at Rasool-e-Akram Hospital from February 2018 to June 2019 were randomized to a tourniquet (<i>n</i> = 46) or a non-tourniquet group (<i>n</i> = 35). Serum levels of anti-Müllerian hormone (AMH) and follicle-stimulating hormone (FSH) were measured before and 3 months after surgery, blood loss was recorded during surgery, and serum levels of hemoglobin (Hb) were recorded before surgery, 6 h and 3 days after surgery. SPSS version 21 was used for statistical analysis. <b><i>Results:</i></b> Demographic, obstetric, and myoma characteristics were similar in the 2 groups (<i>p</i> &#x3e; 0.05). The mean baseline values of AMH and FSH did not differ between groups (<i>p</i> &#x3e; 0.05). After surgery, only FSH was higher in the control group (<i>p</i> = 0.043). Despite the time taken to fasten and open the tourniquet, the mean operating time was shorter in the tourniquet group (<i>p</i> &#x3c; 0.001). Blood loss was higher in the control group (<i>p</i> = 0.005). The drop in Hb levels at 6 h after surgery was higher in the non-tourniquet group (<i>p</i> = 0.002). Blood loss was significantly associated with the duration of surgery (<i>r</i> = 0.523, <i>p</i> &#x3c; 0.001). <b><i>Conclusion:</i></b> The use of a tourniquet during abdominal myomectomy significantly reduced the mean volume of blood loss compared to the non-tourniquet group, while it did not prolong the duration of surgery, nor reduced the ovarian reserve. A tourniquet is a safe and efficient measure during abdominal myomectomy.


1991 ◽  
Vol 19 (4) ◽  
pp. 551-554 ◽  
Author(s):  
A. McCrirrick ◽  
D. T. O. Ramage

The efficacy of a single caudal epidural injection of bupivacaine 20 ml 0.5% following emergency orthopaedic surgery to the lower leg and ankle was investigated. Forty adult patients were studied, randomised to either the caudal or control group. The mean 24 hour postoperative papaveretum consumption was significantly reduced in the caudal group. Analogue pain scores as assessed in a double-blind manner were also significantly reduced in this group. The duration of analgesia after caudal blockade was approximately eight hours as estimated by the average time to the first dose of papaveretum. Our study demonstrates that caudal blockade represents an effective adjunct to intramuscular opiates following this type of surgery.


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