scholarly journals Probiotics Do Not Alter the Long-Term Stability of the Supragingival Microbiota in Healthy Subjects: A Randomized Controlled Trial

Pathogens ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 391
Author(s):  
Christine Lundtorp-Olsen ◽  
Christian Enevold ◽  
Svante Twetman ◽  
Daniel Belstrøm
Keyword(s):  
Oral Health ◽  
Controlled Trial ◽  
Test Group ◽  
External Perturbation ◽  
Controlled Clinical Trial ◽  
Healthy Individuals ◽  
Compositional Stability ◽  
Rdna Sequencing ◽  
Double Blinded

Background: The purpose of the present study was to longitudinally characterize the supragingival microbiota throughout a three months period in orally healthy individuals. We tested the hypothesis that the supragingival microbiota shows a high degree of compositional stability, which is resilient against the external perturbation of regular use of probiotics, as long as oral health is maintained. Methods: The present study was a double-blinded, randomized, placebo-controlled clinical trial. The study population comprised a total of 110 oral and systemic healthy individuals, distributed in a probiotic (n = 55) and placebo (n = 55) group, where the test group consumed tablets with the probiotic strains Lacticaseibacillusrhamnosus (formerly Lactobacillus) PB01 DSM14870 and Latilactobacillus curvatus (formerly Lactobacillus) EB10 DSM32307 for a period of 12 weeks. Supragingival plaque samples and clinical registrations were performed at baseline, and after 4, 8, and 12 weeks, respectively. The supragingival microbiota was characterized by means of 16S rDNA sequencing. Sequences were referenced against the HOMD database. Results: No significant changes of the core microbiota, as expressed by relative abundance of predominant genera and species were evident during the three months observation period in the probiotic or the placebo group. Conclusions: Data from the present study clearly demonstrate long term compositional stability of the supragingival microbiota as long as oral health is maintained. In addition, the tested probiotics had no augmenting effect on the supragingival microbiota in oral health.

Improving Toothbrushing with a Smartphone App: Results of a Randomized Controlled Trial

2019 ◽  
Vol 53 (6) ◽  
pp. 628-635 ◽  
Author(s):  
Mohammad Alkilzy ◽  
Rama Midani ◽  
Margarita Höfer ◽  
Christian Splieth
Keyword(s):  
Oral Health ◽  
Controlled Trial ◽  
Test Group ◽  
Smartphone App ◽  
Control Group ◽  
Health Indices ◽  
Long Term Effect ◽  
Complicated Process ◽  
And Control

Objectives: Performing proper toothbrushing is a complicated process for children. Therefore, the aim of this study was to investigate the effect of a smartphone app for improving manual toothbrushing via a gravitation sensor. Methods: In this prospective, controlled, single-blinded, randomized clinical trial, 49 children (mean age 5.1 ± 0.6 years, 27 female) were randomly assigned to test (n = 26) and control (n = 23) groups. All children were provided with manual toothbrushes with an integrated gravitation sensor and they received oral health instructions. Only the children of the test group got an additional smartphone app to visualize and reward proper brushing in form and time. At baseline and recalls after 6 and 12 weeks, plaque and gingival indices (QHI, PBI) were recorded for analysis between the two groups. Results: At baseline, there were no significant differences between the test and control group regarding plaque and gingival indices (QHI: 2.36 ± 0.7 and 2.42 ± 0.8; p = 0.94; PBI: 0.42 ± 0.2 and 0.47 ± 0.3; p = 0.59). At the 6- and 12-week recalls, the test group showed statistically ­significantly better oral health indices than the controls (6-week recall, QHI: 0.8 ±0.5 and 1.88 ± 0.9; p < 0.001; PBI: 0.08 ± 0.1 and 0.26 ± 0.2; p < 0.001; 12-week recall, QHI: 0.44 ± 0.5 and 1.49 ± 0.7; p < 0.001; PBI: 0.05 ± 0.18 and 0.21 ± 0.1; p < 0.001). Conclusion: The results highlight the enormous possibilities of a toothbrushing application via the smartphone, at least for medium-term oral hygiene improvement in preschool children and even after excluding the app. The long-term effect should also be investigated to exclude the expected novelty effect.

scholarly journals Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Pei Liu ◽  
Weiye Wen ◽  
Ka Fung Yu ◽  
Xiaoli Gao ◽  
Edward Chin Man Lo ◽  
...  
Keyword(s):  
Oral Health ◽  
Pregnant Women ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Oral Health Promotion ◽  
Periodontal Health ◽  
The Mean ◽  
Family Centered

Abstract Background Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum. Methods A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T0), in the 32nd gestational week (T1), and 12 months postpartum (T2). Results Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T0 was 0.19, which decreased to 0.14 at T1 and 0.15 at T2. In the control group, the mean VPI decreased from 0.19 at T0 to 0.16 at T1, but increased to 0.22 at T2. A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T1 and T2. The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T0:57%, T1:46%, T2:35%) than in the control group (T0:58%, T1:52%, T2:46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001). Conclusions Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone. Trial registration Clinicaltrials.gov, #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1

Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial

2020 ◽  
Vol 48 (3) ◽  
pp. 588-598 ◽  
Author(s):  
Jaime R. Garza ◽  
Richard E. Campbell ◽  
Fotios P. Tjoumakaris ◽  
Kevin B. Freedman ◽  
Lawrence S. Miller ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Womac Score ◽  
Percentage Change ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Median Percentage ◽  
Knee Oa ◽  
Symptomatic Knee ◽  
Double Blinded

Background: Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue. Hypothesis: Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority. Results: The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose, P = .04; low dose, P = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose, P = .006; low dose, P = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported. Conclusion: Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA. Registration: NCT02726945 (ClinicalTrials.gov identifier)

scholarly journals Effects of Probiotic Supplementation on Immune Response in Soldiers: A Randomized, Double-Blinded, Placebo-Controlled Trial

2020 ◽  
Vol 18 (3) ◽  
Author(s):  
Mahtab Noorifard ◽  
Elahe Ebrahimi ◽  
Arasb Dabbagh Moghaddam ◽  
Zatollah Asemi ◽  
Ramin Hamidi Farahani ◽  
...  
Keyword(s):  
Immune Response ◽  
Immune System ◽  
Controlled Trial ◽  
Test Group ◽  
Bacillus Coagulans ◽  
Serum Lactate ◽  
Control Group ◽  
Probiotic Supplementation ◽  
Double Blinded ◽  
The Military

Background: Athletic soldiers undergo strenuous and high-endurance training to prepare for competition. Stress and deprivation of proper nutrition can weaken the immune system in athletic soldiers. Therefore, enhancing the immune system function in addition to enhancing the performance of athletic soldiers can lead to a reduction in health costs for the military. Objectives: In this study, the effects of probiotic supplementation on the immune response of soldiers were assessed. Methods: In a randomized, double-blinded, placebo-controlled trial, 42 athletic soldiers were randomly divided into two groups of 21 members. Participants in the probiotic group daily received one glass of fruit juice containing Bacillus coagulans (2 × 109 CFU/g). The control group consumed the placebo at the same time. At the beginning and end of the study, as well as at specific times, IgA, CD4, lactate, and urea were measured in blood samples of all participants. Results: Probiotic supplementation increased the concentration of IgA (+115.7 ± 28.3 vs. -108.3 ± 25.7 mg/dL, P < 0.001) and CD4 levels (+129.1 ± 42.6 vs. -54.5 ± 114.6 cells/µL, P < 0.001) after three months in the test group. In addition, a significant decrease was seen in serum lactate (-5.7 ± 10.1 vs. +10.1 ± 7.4. mg/L, P < 0.001) and urea (-9.9 ± 6.7 vs. +2.3 ± 5.6 mg/dL, P < 0.001) concentrations following probiotic supplementation compared to the placebo. Conclusions: Probiotic consumption for 12 weeks has a positive effect on the immune response of soldiers.

scholarly journals Statistical Analysis Plan for the Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING)

2021 ◽  
Author(s):  
Laurent Billot ◽  
Helen Monaghan ◽  
Muh Geot Wong ◽  
Vlado Perkovic
Keyword(s):  
Statistical Analysis ◽  
Iga Nephropathy ◽  
Controlled Trial ◽  
Renin Angiotensin System ◽  
Statistical Analysis Plan ◽  
Therapeutic Evaluation ◽  
Global Study ◽  
Risk Of Disease ◽  
Double Blinded

The TESTING (Therapeutic Evaluation of STeroids in IgA Nephropathy Global) study is a multicenter, double-blinded, randomised, placebo-controlled trial designed to evaluate the long-term efficacy and safety of oral methylprednisolone, on a background of routine renin angiotensin system (RAS) inhibitor therapy, in preventing kidney events in patients with IgA nephropathy with features suggestive of a high risk of disease progression. This statistical analysis plan (SAP) provides the details of all pre-specified analyses to be conducted at the end of the trial. The SAP was written by the trial statistician, chief investigator, study director and project manager and approved by the management committee.

scholarly journals Clinical Efficacy of Intra-Articular Injection With P-PRP Versus That of L-PRP in Treating Knee Cartilage Lesion: A Randomized Controlled Trial.

2021 ◽  
Author(s):  
Yiqin Zhou ◽  
Haobo Li ◽  
Shiqi Cao ◽  
Yaguang Han ◽  
Jiahua Shao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Efficacy ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Womac Pain ◽  
Knee Cartilage ◽  
Cartilage Lesions ◽  
Randomized Controlled

Abstract Background: To evaluate the clinical efficacy and safety of intra-articular injection with pure platelet-rich plasma (P-PRP) versus those of leukocyte platelet-rich plasma (L-PRP) in treating knee cartilage lesions, we conducted a double-blind, randomized controlled clinical trial with a larger sample and longer follow-up period.Methods: From October 2019 to October 2020, 95 patients were invited to participate in our study, and 60 (63.2%) were randomized to P-PRP (n = 30) or L-PRP (n = 30) groups. Patients from the two groups were treated with knee intra-articular injections of P-PRP or L-PRP. Visual analog scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were assessed preoperatively and at 6 weeks, 12 weeks, 6 months, and 12 months after intervention.Results: We followed up 27 cases in the P-PRP group and 26 cases in the L-PRP group. No significant differences in VAS and WOMAC scores were found between the two groups before the intervention (P>0.05). The WOMAC Pain and VAS-Motions scores of the P-PRP group were significantly lower than those of the L-PRP group at 6 weeks after the intervention (P<0.05). While the long-term clinical efficacy of both injections was similar and weakened after 12 months, more adverse events were found in the L-PRP group.Conclusions: The short-term results of our study are encouraging and demonstrate that both L-PRP and P-PRP intra-articular injections reduce pain and improve function in patients with knee cartilage lesions. Compared with the L-PRP injection, the P-PRP injection (which had a lower risk of early inflammation caused by leukocytes) showed better clinical efficacy in the early phase of postoperative rehabilitation and resulted in fewer adverse events. However, long-term clinical efficacy for both injections were similar and weakened after 12 months.Trial registration: ChiCTR1900026365. Registered on 3 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=43911.

Effectiveness of low-dose radiation therapy on symptoms in patients with knee osteoarthritis: a randomised, double-blinded, sham-controlled trial

2018 ◽  
pp. annrheumdis-2018-214104 ◽  
Author(s):  
Elien A M Mahler ◽  
Michiel JM Minten ◽  
Mathilde M Leseman-Hoogenboom ◽  
Philip M P Poortmans ◽  
Jan Willem H Leer ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Knee Osteoarthritis ◽  
Low Dose ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Low Dose Radiation ◽  
Knee Oa ◽  
Sham Intervention ◽  
Double Blinded ◽  
Dose Radiation

ObjectivesLow-dose radiation therapy (LDRT) for benign disorders such as knee osteoarthritis (OA) is widely used in some parts of the world, despite absence of controlled studies. We evaluated the effect of LDRT on symptoms and inflammation in patients with knee OA.MethodsIn this randomised, double-blinded, sham-controlled clinical trial (RCT), we recruited patients with knee OA (clinical ACR criteria) in the Netherlands, aged ≥50 years, pain score ≥5/10 and non-responding to analgesics and exercise therapy. Patients were randomised 1:1 to receive LDRT (1 Gray per fraction) or sham intervention six times in 2 weeks, stratified by pain (<8 versus ≥8/10). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months postintervention. Secondary outcomes included pain, function and inflammatory signs assessed by ultrasound, MRI and serum inflammatory markers.ResultsWe randomly assigned 55 patients: 27 (49%) to LDRT and 28 (51%) to sham. At 3 months postintervention, 12/27 patients (44%; 95%  CI 26% to 63%) in the LDRT vs 12/28 patients (43%; 95%  CI 25% to 61%) in the sham group responded; difference 2% (95% CI 25% to 28%), OR adjusted for the stratifying variable was 1.1 (95% CI 0.4 to 3.2). Also, for clinical and any of the inflammatory signs, no differences were observed.ConclusionsWe found no substantial beneficial effect on symptoms and inflammatory signs of LDRT in patients knee OA, compared with sham treatment. Therefore, based on this RCT and the absence of other high-quality evidence, we advise against the use of LDRT as treatment for knee OA.Trial registration numberNTR4574.

scholarly journals The effect of galvanization and potassium iodide iontophoresis of the throat and larynx on thyroid parameters: a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jolanta Zwolińska ◽  
Barbara Augustyn ◽  
Katarzyna Baj ◽  
Jadwiga Krukowska
Keyword(s):  
Randomized Controlled Trial ◽  
Potassium Iodide ◽  
Controlled Trial ◽  
Thyroid Ultrasonography ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Thyroid Hormone Levels ◽  
Double Blinded

AbstractFew studies have assessed the application and side effects of potassium iodide (KI) iontophoresis. Using a double-blinded randomized controlled trial with a 1:1 parallel-group, we investigated the effect of galvanization and the KI iontophoresis in the throat and larynx on three thyroid parameters. A total of 50 healthy volunteers with normal TSH, FT3, and FT4 levels and lacking focal changes in the thyroid ultrasonography were subjected to 10 electrotherapy treatments. The TSH, FT3, and FT4 levels were determined prior to the 10 electrotherapeutic treatments (T1), 2-weeks after treatment (T2) and 6-months after treatment (T3). At T2 and T3, both groups had normal levels of TSH, FT3, and FT4. Regarding the change of TSH, FT3, and FT4 levels between T1 vs. T2 and T1 vs. T3, no significant differences between the galvanization and iontophoresis groups were found. However, both groups had lower levels of all three hormones at T3. Together, these data indicate that KI iontophoresis does not affect thyroid hormone levels in the short- nor long-term. Additional follow-up studies with larger groups are required to better confirm the safety of galvanization and iontophoresis procedures in the pharynx and larynx.Trial registration ClinicalTrials.gov (NCT04013308; URL: www.clinicaltrials.gov). Day of first registration 09/07/2019.

scholarly journals Effects of Active Oxygen Toothpaste in Supragingival Biofilm Reduction: A Randomized Controlled Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Emanuelle Juliana Cunha ◽  
Caroline Moreira Auersvald ◽  
Tatiana Miranda Deliberador ◽  
Carla Castiglia Gonzaga ◽  
Fernando Luis Esteban Florez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dental Students ◽  
Active Oxygen ◽  
Controlled Clinical Trial ◽  
Preclinical Trial ◽  
Time Period ◽  
Experimental Gingivitis ◽  
Plaque Control ◽  
Double Blinded

Gingivitis is still considered a major risk factor for the occurrence and progression of periodontal disease. The aim of the present study was to compare the long-term (1, 12, and 18 weeks) antiplaque and antigingivitis efficacies of two commercially available toothpastes, Colgate Total® (CT) and BlueM® (BM), against attached supragingival dental plaque and gingival inflammation in an experimental gingivitis model. A parallel double-blinded randomized clinical trial including 39 dental students who refrained from all plaque control methods (manual or chemical) for 7 days was conducted. After the establishment of clinical gingivitis, participants were randomized into two experimental groups (CT and BM). Plaque index (PI) and gingival index (GI) were then calculated according to Turesky’s modified Quigley and Hein index. Participants were assessed in four time periods (preclinical trial phase (W −1), gingivitis phase (W0), one week (W1), twelve weeks (W12), and eighteen weeks (W18)). Participants’ stimulated saliva was collected and cultured (either aerobically or anaerobically, 37°C, 48 hours) in each time period (W −1, W0, W1, W12, and W18) for the count of viable colonies. Obtained data were analyzed using 2-way ANOVA and Tukey’s test (α = 0.05). No significant differences were found (p>0.05) between experimental groups at W −1. Significant differences between groups were observed at W0 (p<0.05) for the parameter time period, but not for the interaction between parameters (time period ∗ toothpastes). Lower bacterial counts were observed in both groups after one week of toothbrushing; however, no significant differences were found between investigated dentifrices. Intra- and intergroup comparisons revealed that significant differences were not found (p>0.05) between dentifrices at W1, W12, and W18 for both GI and PI. The present study demonstrated that toothpastes containing active oxygen and lactoferrin (BM) have comparable antiplaque and antigingivitis efficacies with triclosan-containing toothpastes (CT).

Sign in / Sign up

Export Citation Format

Share Document