A randomized, controlled, parallel group clinical study of cigarette smokers using an innovative oral tobacco-derived nicotine product to determine impact on cigarette consumption and biomarkers of exposure

2020 ◽  
Author(s):  
Jeffery Edmiston ◽  
Qiwei Liang ◽  
Jianmin Liu ◽  
Mohamadi Sarkar
Keyword(s):  
Test Group ◽  
Cigarette Consumption ◽  
Control Group ◽  
Cigarette Smokers ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Parallel Group ◽  
Ad Libitum ◽  
Use Behavior ◽  
Related Harm

Abstract Background: Despite the well-known health consequences of cigarettes, many adults still smoke. VERVE® Blue Mint Discs (Discs) are innovative, chewable, non-dissolvable oral tobacco-derived nicotine products designed for adult smokers (AS) interested in alternatives to cigarettes. We assessed impact of using Discs on product use behavior and biomarkers of exposure (BOE) in AS. Methods: In this randomized, two-arm, parallel group study, AS (n=154) not planning to quit in the next 30 days were randomized to either a Control Group (n=62) that continued smoking their own brand cigarettes or Test Group (n=92) with the option to use Discs for four weeks under ad libitum conditions. Changes from Baseline to End of Study (EOS) between the Groups were analyzed for CPD and BOEs to select harmful and potentially harmful constituents (HPHCs) – nicotine, NNK, benzene and carbon monoxide. Results: Most AS (78%) in the Test Group reduced their CPD (~20% on average, p<0.05), some (~9.4%) reducing by 50-99% and a few (~2.4%) switched completely to Discs. The changes in CPD was biochemically confirmed with significant reductions in COHb (p<0.05). Percent changes in BOEs for nicotine, NNK and benzene tended to be lower in participants using Discs compared to the Control Group indicating lower exposure to HPHCs. Conclusions: Overall, our results suggest that many AS reduced their cigarette consumption, and some switched completely to Discs. Switching completely from cigarettes to Discs, if sustained over time, may offer an opportunity for smoking-related harm reduction. (238 words)

scholarly journals Feasibility Study of an Educational Intervention to Improve Water Intake in Adolescent Soccer Players: A Two-Arm, Non-Randomized Controlled Cluster Trial

2021 ◽  
Vol 18 (3) ◽  
pp. 1339
Author(s):  
Rubén Martín-Payo ◽  
María del Mar Fernández-Álvarez ◽  
Edurne Zabaleta-del-Olmo ◽  
Rebeca García-García ◽  
Xana González-Méndez ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Water Consumption ◽  
Intervention Group ◽  
Soccer Players ◽  
Consumption Pattern ◽  
Control Group ◽  
Personal Factors ◽  
Cluster Trial ◽  
Randomized Controlled ◽  
Ad Libitum

This study aimed to assess the feasibility of an educational intervention on hydration behavior in adolescent soccer players. A pilot study of a two-arm, non-randomized controlled cluster trial was conducted. A total of 316 players aged 13–16 agreed to participate. The response variables were the players’ participation in the intervention, their perception of the knowledge acquired, the usefulness and the overall assessment of the intervention. Hydration patterns and acquisition of knowledge on hydration behavior were also assessed. The intervention involved two elements: posters and a web app. A total of 259 adolescents completed the study (intervention group (IG) = 131; control group (CG) = 128). 80.6% of the players responded to the survey assessing the feasibility of the intervention. The mean number of correct answers regarding behavior was significantly higher in the IG (3.54; SD = 1.162) than in the CG (2.64; SD = 1.174) (p < 0.001). The water consumption pattern at all the clubs was ad libitum. Of the players, 10% did not drink any water at all during the game. In conclusion, this intervention has been shown to be feasible for implementation with adolescent soccer players. It suggests that hydration guidelines should be informed by personal factors and that ad libitum water consumption should be avoided.

scholarly journals Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty

2018 ◽  
Vol 129 (4) ◽  
pp. 1017-1023 ◽  
Author(s):  
Eduardo Vieira ◽  
Thiago C. Guimarães ◽  
Igor V. Faquini ◽  
Jose L. Silva ◽  
Tammy Saboia ◽  
...  
Keyword(s):  
Wound Infection ◽  
Decompressive Craniectomy ◽  
Surgical Complications ◽  
Test Group ◽  
Csf Leak ◽  
Control Group ◽  
Surgical Time ◽  
Randomized Controlled ◽  
The Mean ◽  
Fluid Collections

OBJECTIVEDecompressive craniectomy (DC) is a widely used procedure in neurosurgery; however, few studies focus on the best surgical technique for the procedure. The authors’ objective was to conduct a prospective randomized controlled trial comparing 2 techniques for performing DC: with watertight duraplasty and without watertight duraplasty (rapid-closure DC).METHODSThe study population comprised patients ranging in age from 18 to 60 years who were admitted to the Neurotrauma Service of the Hospital da Restauração with a clinical indication for unilateral decompressive craniectomy. Patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) and without watertight duraplasty (test group). After unilateral DC was completed, watertight duraplasty was performed in the control group, while in the test group, no watertight duraplasty was performed and the exposed parenchyma was covered with Surgicel and the remaining dura mater. Patients were then monitored daily from the date of surgery until hospital discharge or death. The primary end point was the incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections). The following were analyzed as secondary end points: clinical outcome (analyzed using the Glasgow Outcome Scale [GOS]), surgical time, and hospital costs.RESULTSFifty-eight patients were enrolled, 29 in each group. Three patients were excluded, leaving 27 in the test group and 28 in the control group. There were no significant differences between groups regarding age, Glasgow Coma Scale score at the time of surgery, GOS score, and number of postoperative follow-up days. There were 9 surgical complications (5 in the control group and 4 in the test group), with no significant differences between the groups. The mean surgical time in the control group was 132 minutes, while in the test group the average surgical time was 101 minutes, a difference of 31 minutes (p = 0.001). The mean reduction in total cost was $420.00 USD (a 23.4% reduction) per procedure in the test group.CONCLUSIONSRapid-closure DC without watertight duraplasty is a safe procedure. It is not associated with a higher incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections), and it decreased surgical time by 31 minutes on average. There was also a hospital cost reduction of $420.00 USD (23.4% reduction) per procedure.Clinical trial registration no.: NCT02594137 (clinicaltrials.gov)

A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ifra Abdul Qaiyyum ◽  
Mohammad Nawab ◽  
Munawwar Husain Kazmi
Keyword(s):  
Quality Of Life ◽  
Test Group ◽  
Control Group ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
End Point ◽  
Intergroup Comparison ◽  
And Control ◽  
Change In Mean

Abstract Objectives Kalaf (Melasma) is an acquired facial hypermelanism. It has direct impact on patient’s quality of life and leads to development of various personality disorders. Lack of effective treatment and recurrences have drawn the attention of researcher to find alternative treatment. This study aimed to evaluate safety and efficacy of a topical Unani formulation in the management of melasma. Methods We conducted a prospective randomized controlled clinical study on the participants diagnosed with melasma. The participants (n=72) randomized into test (n=36) and control (n=36) groups. Sixty participants (n=30 in each group) completed the duration of therapy. The participants of the test group were treated with a classical Unani formulation and control group with hydroquinone 4%. The primary end point was change in mean MASI score and secondary end point was improvement in quality of life after eight weeks of treatment. Results The Unani formulation reduced 40.5% mean MASI score (17.31 ± 9.58 to 10.28 ± 5.92) in comparison to 32% reduction in mean MASI score (20.58 ± 9.49 to 13.92 ± 7.38) in the control group after eight weeks of treatment. When comparing with baseline the difference in MASI score was found statistically significant in both groups (p<0.05). On intergroup comparison, the change in MASI score between both groups was not statistically significant (p>0.05). In addition, MQOL and DQLI also improved significantly in both groups. Conclusions This study concluded that the Unani formulation and the control drug were equally effective and safer in the management of melasma.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study

2020 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M Camacho ◽  
George Hardie ◽  
James Murphy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Tobacco Product ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Never Smokers

Abstract Introduction Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes. Aims and Methods This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90. Results In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers. Conclusion glo is a reduced-exposure tobacco product. Implications This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely. Clinical trial registration ISRCTN81075760.

Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults

2019 ◽  
Vol 41 (5) ◽  
pp. 495-501 ◽  
Author(s):  
Carole Charavet ◽  
Geoffrey Lecloux ◽  
Nastasia Jackers ◽  
Adelin Albert ◽  
France Lambert
Keyword(s):  
Orthodontic Treatment ◽  
Treatment Time ◽  
Controlled Trial ◽  
Test Group ◽  
University Hospital ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Overall Treatment Time ◽  
Randomized Controlled ◽  
Cad Cam

Summary Objective The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances. Design The study is designed as a parallel group, randomized controlled trial (RCT). Setting University Hospital. Ethical approval The study was approved by the ethic committee of the University Hospital Liege, Belgium. Subjects and methods This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study. Outcome measures The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated. Results A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases. Limitations This trial was a single-centre trial. Conclusions Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists. Registration ClinicalTrails.gov (Identifier: NCT03406130)

scholarly journals Effect of advanced periodontal self-care in patients with early-stage periodontal diseases on endothelial function: An open-label, randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257247
Author(s):  
Ayako Okada ◽  
Takatoshi Murata ◽  
Khairul Matin ◽  
Meu Ariyoshi ◽  
Ryoko Otsuka ◽  
...  
Keyword(s):  
Early Stage ◽  
Periodontal Diseases ◽  
Controlled Trial ◽  
Self Care ◽  
Test Group ◽  
Control Group ◽  
Atherosclerotic Cardiovascular Disease ◽  
Adma Level ◽  
Open Label ◽  
Randomized Controlled

Although a significant association between periodontal disease and atherosclerotic cardiovascular disease has been reported, their cause-to-effect relationship remains controversial. This randomized controlled clinical trial aimed to investigate the effect of advanced self-care on atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level in patients with early-stage periodontal disease. The study was designed as a parallel group, 3-month follow-up, open-label, randomized controlled trial. The control group received standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray for advanced self-care twice a day. Overall, 110 patients provided data for FMD and serum ADMA level. No significant improvements in FMD were observed in the control (mean increase, −0.1%; 95% confidence interval [CI], −1.0–0.8; P = 0.805) or test (mean increase, −0.3%; 95% CI, −1.1–0.4; P = 0.398) group. No significant changes in serum ADMA levels were observed (mean reduction, 0.01 μmol/L; 95% CI, −0.00–0.02; P = 0.366 and mean reduction, 0.00 μmol/L; 95% CI, −0.01–0.01; P = 0.349, respectively). No significant between-group differences were found in FMD (mean difference, −0.2%; 95% CI, −1.4–0.9; p = 0.708) or serum ADMA levels (mean difference, 0.01 nmol/L; 95% CI, −0.00–0.03; p = 0.122). Significant improvements in the average probing pocket depth were observed in the control and test groups. The bleeding on probing score in the test group was significantly reduced, while that in the control group was reduced, although not significantly. Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases. This trial is registered in UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/; ID: UMIN000023395).

scholarly journals Contribution of piezocision in oral surgery: the example of the acceleration of orthodontic movements

2021 ◽  
Vol 8 (3) ◽  
pp. 184-188
Author(s):  
Francois Thonnart ◽  
◽  
Simon Systermans ◽  
Yves Gilon ◽  
◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Orthodontic Treatment ◽  
Oral Surgery ◽  
Test Group ◽  
Surgical Approaches ◽  
Control Group ◽  
Controlled Trials ◽  
Publication Date ◽  
Randomized Controlled ◽  
Pubmed Database

Introduction Patients are more demanding of short or less invasive interventions. Piezocision responds well to this demand, particularly in the case of piezo-guided corticotomy to accelerate orthodontic movements. Different surgical approaches are described to shorten orthodontic procedures. Corticotomy is a surgical process where osteotomies are realized at the level of the cortical part of the bone. Objective The aim of this work is to review the contribution of piezocision in oral surgery, using as example a review over the current results of piezocision on the acceleration of orthodontic movements. Data sources The articles referenced and used in this article come from the PubMed database. The searched keywords were "piezocision" alone or in combination with "orthodontics". Study selection This search resulted in 44 available articles. Subsequently, 6 randomized controlled trials were selected based on relevance, journal, and publication date. Four Randomized Controlled Trials and two Controlled Clinical Trials were studied. Data extraction The reviewer assessed each article for their relevance and methodology. The 6 studies compared the time savings between conventional orthodontic treatment (control group) and orthodontic treatment combined with piezocision surgery (test group). Data synthesis Piezocision corticotomy reduces the operation and the postoperative period and increases the acceptance of corticotomies and their indications.

scholarly journals Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

2019 ◽  
Author(s):  
Pei-Hui Ding ◽  
Anna Dai ◽  
Hua-Jiao Hu ◽  
Jia-Ping Huang ◽  
Jia-Mei Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Test Group ◽  
Periodontal Therapy ◽  
Control Group ◽  
Carbonate Apatite ◽  
Dentine Hypersensitivity ◽  
Randomized Controlled ◽  
At Home

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules. It has been demonstrated that nano-sized particles could seal these the dentine tubules. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for VAS, test group: 0.66 ± 0.68 versus control group: 0.84 ± 0.78, p = 0.005; for Schiff score, test group: 0.69 ± 0.71 versus control group: 0.97 ± 0.77, p < 0.001). Conclusions: Home-use of n-CAP based dentifrice provided a significantly better alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trail registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017)

scholarly journals The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2950 ◽  
Author(s):  
Tamara Sorić ◽  
Mladen Mavar ◽  
Ivana Rumbak
Keyword(s):  
Metabolic Syndrome ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dash Diet ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Schizophrenic Patients ◽  
The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

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