scholarly journals A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Mouthwash Containing Glycyrrhiza uralensis Extract for Preventing Dental Caries

2021 ◽  
Vol 19 (1) ◽  
pp. 242
Author(s):  
Yu-Rin Kim ◽  
Seoul-Hee Nam
Keyword(s):  
Dental Caries ◽  
Health Management ◽  
Oral Care ◽  
Glycyrrhiza Uralensis ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Microbiological Analysis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Caries Activity

This study sought to confirm the effect of using a mouthwash containing Glycyrrhiza uralensis extract for oral health management by investigating changes in the pH of dental plaque and bacteria that cause dental caries. A randomized, double-blind, placebo-controlled study was conducted on 60 subjects categorized in either the Glycyrrhiza uralensis extract gargle group (n = 30) or the saline gargle group (n = 30). Scaling was conducted in order to ensure the homogeneity of the oral environment, while gargling was performed once daily before the subjects went to bed for 5 days based on the group. Caries activity was assessed using the Cariview test, while detection of the bacteria that cause dental caries was confirmed using microbiological analysis. All clinical measurements and evaluations were conducted by two trained dental hygienists under the supervision of a dentist. Based on the analysis of dental caries activity and dental caries-causing bacteria, the Glycyrrhiza uralensis extract gargle group showed a clear decrease in bacteria compared to the saline gargle group. Glycyrrhiza uralensis extract demonstrated no risk of tooth demineralization. It also showed excellent antibacterial activity through inhibition and effective reduction of bacteria that cause dental caries. Therefore, the mouthwash containing Glycyrrhiza uralensis extract is an effective oral care product suitable for use as an effective dental caries prevention agent.

Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial

2021 ◽  
Vol 46 (4) ◽  
pp. 322-327
Author(s):  
Marina Bertuit ◽  
Francesca Rapido ◽  
Habib Ly ◽  
Charlotte Vannucci ◽  
Jérôme Ridolfo ◽  
...  
Keyword(s):  
Postoperative Analgesia ◽  
Severe Pain ◽  
Postoperative Nausea And Vomiting ◽  
Sensory Innervation ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Block Group ◽  
Double Blind ◽  
Double Blind Placebo

BackgroundThe sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies.Methods107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis.ResultsThe cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0–21.3) vs 12.0 mg (IQR 8.0–22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV.ConclusionBilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence.Trial registration numberNCT02618993.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial.

1998 ◽  
Vol 16 (4) ◽  
pp. 1574-1581 ◽  
Author(s):  
A N Serafini ◽  
S J Houston ◽  
I Resche ◽  
D P Quick ◽  
F M Grund ◽  
...  
Keyword(s):  
Pain Relief ◽  
Bone Metastases ◽  
Active Drug ◽  
Opioid Analgesic ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Complete Relief ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive

PURPOSE To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

scholarly journals Safety and Efficacy of the Combination of BCc1 and Hep-S Nanochelating-Based Medicines in Hospitalized COVID-19 Adult Patients: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Maryam Hafizi ◽  
Somayeh Kalanaky ◽  
Saideh Fakharzadeh ◽  
Atefeh Fakharian ◽  
Somayeh Lookzadeh ◽  
...  
Keyword(s):  
Treatment Group ◽  
Inflammatory Cytokines ◽  
Clinical Symptoms ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Reduce Mortality Rate ◽  
Tnf Α

Abstract Background: The mortality and morbidity of COVID‐19 disease as well as the lack of a proper medication has forced researchers and clinicians to employ urgent efficient technologies to overcome this current pandemic. In the severe forms of COVID-19, the patients develop a cytokine storm syndrome (CSS) where pro-inflammatory cytokines such as IL-6 and TNF-α play a key role in the development of this serious process. The efficiency of nanomedicines - as efficient immunomodulators - that are synthesized based on nanochelating technology have been proved in the previous studies. In the present study, the therapeutic effect of the combination of BCc1 and Hep-S nanomedicines on hospitalized COVID-19 patients was evaluated.Method: Laboratory-confirmed moderate COVID-19 patients at Masih Daneshvari Hospital were enrolled to participate in a randomized, double-blind, placebo-controlled study in two separate groups: combination of BCc1 and Hep-S (N=62) (treatment) or placebo (N=60) (placebo). The primary outcome of the study was evaluating the safety of the nanomedicines combination and its effect on the number of deceased patients, while the secondary outcome was decrease in inflammatory cytokines.Results: The evaluation of blood biochemical indices as well as clinical symptoms showed that adding the combination of BCc1 and Hep-S nanomedicines to the standard protocol of the treatment caused no adverse effects. The results analysis revealed that 28-day consumption of the nanomedicines led to a significant decrease in the mean level of IL-6 cytokine of the patients in the treatment group (p < 0.05). In addition, the patients in the treatment group had lower TNF-α levels compared to those in the control (p > 0.05) and they also showed less need for oxygen therapy. Finally, the number of the deceased patients in the treatment group was 30% lower than that of the control (p > 0.05).Conclusion: The combination of BCc1 and Hep-S, as safe nanomedicines, inhibits IL-6 as a highly important and well-known cytokine in COVID-19 pathophysiology, and presents a promising view for immunomodulation that can manage CSS and reduce mortality rate in COVID19 patients.Trial registration IRCTID, IRCT20170731035423N2. Registered 12 Jun 2020, http://www.irct.ir/ IRCT20170731035423N2.

scholarly journals A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study

2020 ◽  
Vol 112 (2) ◽  
pp. 334-342 ◽  
Author(s):  
Juntao Kan ◽  
Min Wang ◽  
Ying Liu ◽  
Hongyue Liu ◽  
Liang Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dry Eye ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Eye Fatigue ◽  
Nutritional Strategy ◽  
Significant Difference ◽  
Break Up

ABSTRACT Background With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms. Objectives The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial. Methods We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study. Results Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits. Conclusions Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).

scholarly journals The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2940
Author(s):  
Marina Perić ◽  
Dominique Maiter ◽  
Etienne Cavalier ◽  
Jérôme F. Lasserre ◽  
Selena Toma
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Test Group ◽  
Controlled Study ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Pocket Depth ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial

2013 ◽  
Vol 62 (6) ◽  
pp. 875-884 ◽  
Author(s):  
Jeremy P. Burton ◽  
Bernadette K. Drummond ◽  
Chris N. Chilcott ◽  
John R. Tagg ◽  
W. Murray Thomson ◽  
...  
Keyword(s):  
Oral Health ◽  
Dental Caries ◽  
Controlled Trial ◽  
Health Benefits ◽  
Controlled Study ◽  
Streptococcus Salivarius ◽  
Double Blind ◽  
Plaque Score ◽  
Double Blind Placebo ◽  
Probiotic Treatment

The prevalence of dental caries continues to increase, and novel strategies to reverse this trend appear necessary. The probiotic Streptococcus salivarius strain M18 offers the potential to confer oral health benefits as it produces bacteriocins targeting the important cariogenic species Streptococcus mutans, as well as the enzymes dextranase and urease, which could help reduce dental plaque accumulation and acidification, respectively. In a randomized double-blind, placebo-controlled study of 100 dental caries-active children, treatment with M18 was administered for 3 months and the participants were assessed for changes to their plaque score and gingival and soft-tissue health and to their salivary levels of S. salivarius, S. mutans, lactobacilli, β-haemolytic streptococci and Candida species. At treatment end, the plaque scores were significantly (P = 0.05) lower for children in the M18-treated group, especially in subjects having high initial plaque scores. The absence of any significant adverse events supported the safety of the probiotic treatment. Cell-culture analyses of sequential saliva samples showed no differences between the probiotic and placebo groups in counts of the specifically enumerated oral micro-organisms, with the exception of the subgroup of the M18-treated children who appeared to have been colonized most effectively with M18. This subgroup exhibited reduced S. mutans counts, indicating that the anti-caries activity of M18 probiotic treatments may be enhanced if the efficiency of colonization is increased. It was concluded that S. salivarius M18 can provide oral health benefits when taken regularly.

scholarly journals Evaluation of aCrataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Miao Hu ◽  
Weiwei Zeng ◽  
Brian Tomlinson
Keyword(s):  
Adverse Effects ◽  
Active Treatment ◽  
Chinese Patients ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Laboratory Safety ◽  
Polygonum Multiflorum ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Safety Parameters

Background.We for the first time examined the effects of a multiherb formula containingCrataegus pinnatifida(1 g daily),Alisma orientalis,Stigma maydis,Ganoderma lucidum,Polygonum multiflorum, andMorus albaon plasma lipid and glucose levels in Chinese patients with dyslipidemia.Methods.In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment.Results.The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly(P<0.05)better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%)(P=0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment.Conclusions.The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.

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