scholarly journals Microbiological and clinical evaluation of ultrasonic debridement with/without erythritol air polishing during supportive periodontal therapy in arches with full-arch fixed implant-supported prostheses: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053286
Author(s):  
Jingwen Yang ◽  
Pingyi Jia ◽  
Zhaoguo Yue ◽  
Jianzhang Liu ◽  
Zhongning Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Pathogenic Bacteria ◽  
Controlled Trial ◽  
Bacterial Flora ◽  
Periodontal Therapy ◽  
Plaque Removal ◽  
Air Polishing ◽  
Supportive Periodontal Therapy ◽  
Group 2 ◽  
Randomised Controlled

IntroductionImplant-supported prostheses are often successfully used in edentulous patients. However, the incidences of peri-implant mucositis and peri-implantitis increase over time. The accumulation of pathogenic bacteria adjacent to prostheses can induce peri-implant disease. Plaque removal is recommended to prevent and manage peri-implant diseases. The purpose of this study is to compare the plaque removal efficacy of ultrasonic debridement with/without erythritol air-polishing powder around implants and bridges in patients with full-arch fixed implant-supported prostheses as well as the effects of these two methods on the rates of peri-implant mucositis and peri-implantitis, and the submucosal microbiota composition over 5 years in patients undergoing supportive periodontal therapy.Methods and analysisWe plan to enrol 10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses. The study will use a split-mouth model in which contralateral quadrants are randomly assigned to two groups. Group 1: one contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement combined with erythritol air-polishing powder. Group 2: a separate contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement. The 5-year trial will involve a total of 10 re-examinations per participant. The mucosal conditions around the implants will be recorded at 6-month intervals after restoration. Peri-implant submucosal plaque will be collected at each re-examination, and the bacterial flora will be analysed by 16s ribosomal RNA gene sequencing. X-ray examinations will be conducted at 12-month intervals to evaluate the marginal bone level around implants.Ethics and disseminationThis prospective single-centre, randomised controlled trial (PKUSSIRB-202054045) has been approved by the Ethics Committee of Stomatology School and Hospital of Peking University. Data will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results via publication in scientific journals.Trial registration numberChiCTR-2000032431.

Azithromycin and metronidazole versus metronidazole-based therapy for the induction of remission in mild to moderate paediatric Crohn’s disease : a randomised controlled trial

Gut ◽  
2018 ◽  
Vol 68 (2) ◽  
pp. 239-247 ◽  
Author(s):  
Arie Levine ◽  
Michal Kori ◽  
Jarek Kierkus ◽  
Rotem Sigall Boneh ◽  
Malgorzata Sladek ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Randomised Controlled Trial ◽  
Crohn's Disease ◽  
Activity Index ◽  
Controlled Trial ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Group 2 ◽  
Randomised Controlled ◽  
Group 1

ObjectiveCrohn’s disease (CD) pathogenesis associated with dysbiosis and presence of pathobionts in the lumen, intracellular compartments and epithelial biofilms. Azithromycin is active in all three compartments. Our goal was to evaluate if azithromycin-based therapy can improve response and induce remission compared with metronidazole alone in paediatric CD.DesignThis blinded randomised controlled trial allocated children 5–18 years with 10<Pediatric Crohn’s Disease Activity Index (PCDAI)≤40 to azithromycin 7.5 mg/kg, 5 days/week for 4 weeks and 3 days/week for another 4 weeks with metronidazole 20 mg/kg/day (group 1) or metronidazole alone (group 2), daily for 8 weeks. Failures from group 2 were offered azithromycin as open label. The primary end point was response defined by a decrease in PCDAI>12.5 or remission using intention to treat analysis.Results73 patients (mean age 13.8±3.1 years) were enrolled, 35 to group 1 and 38 to group 2. Response and remission rates at week 8 were identical 23/35 (66%) in group 1 and 17/38 (45%) and 15/38 (39%) in group 2 (P=0.07 and P=0.025, respectively). The needed to treat for remission was 3.7. Faecal calprotectin declined significantly in group 1 (P=0.003) but not in group 2 (p=0.33), and was lower at week 8 (P=0.052). Additional therapy was required in 6/35(17%) from group 1 versus 16/38(42%) in group 2 (P=0.027) by week 8. Among 12 failures in group 2, open-label azithromycin led to remission in 10/12 (83%).ConclusionsThe combination of azithromycin and metronidazole failed to improve response but was superior for induction of remission and reduction in calprotectin.Trial registration numberNCT01596894.

scholarly journals Correction to: Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial)

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Paula Guedes Cocate ◽  
Gilberto Kac ◽  
Berit Lilienthal Hieitmann ◽  
Paulo Nadanovsky ◽  
Maria Cláudia da Veiga Soares Carvalho ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Periodontal Therapy ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial)

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Paula Guedes Cocate ◽  
Gilberto Kac ◽  
Berit L. Heitmann ◽  
Paulo Nadanovsky ◽  
Maria Cláudia da Veiga Soares Carvalho ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Low Income ◽  
Controlled Trial ◽  
Periodontal Therapy ◽  
Periodontal Health ◽  
Powdered Milk ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Periodontitis is a common oral inflammation, which is a risk factor for adverse pregnancy outcomes. Intakes of vitamin D and calcium are inversely associated with occurrence and progression of periodontitis. This study aims to assess the feasibility of a multi-component intervention, including provision of milk powder supplemented with calcium and vitamin D and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles of low-income Brazilian pregnant women with periodontitis. Methods The IMPROVE trial is a feasibility randomised controlled trial (RCT) with a 2 × 2 factorial design with a parallel process evaluation. Pregnant women with periodontitis, aged 18–40 years and with < 20 gestational weeks (n = 120) were recruited and randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus PT during pregnancy, (2) placebo sachet and powdered milk plus PT during pregnancy, (3) fortified sachet (vitamin D and calcium) and powdered milk plus PT after delivery and (4) placebo sachet and powdered milk plus PT after delivery. Dentists and participants are blinded to fortification. Acceptability of study design, recruitment strategy, random allocation, data collection procedures, recruitment rate, adherence and attrition rate will be evaluated. Data on serum levels of vitamin D, calcium and inflammatory biomarkers; clinical periodontal measurements; anthropometric measurements; and socio-demographic questionnaires are collected at baseline, third trimester and 6–8 weeks postpartum. Qualitative data are collected using focus group, for analysis of favourable factors and barriers related to study adherence. Discussion Oral health and mineral/vitamin supplementation are much overlooked in the public prenatal assistance in Brazil and of scarcity of clinical trials addressing these issues in low and middle-income countries,. To fill this gap the present study was designed to assess the feasibility of a RCT on acceptability of a multi-component intervention combining conventional periodontal treatment and consumption of milk fortified with calcium-vitamin D for improving periodontal conditions and maternal metabolic and inflammation status, among Brazilian low-income pregnant women with periodontitis. Thus, we hope that this relatively low-cost and safe multicomponent intervention can help reduce inflammation, improve maternal periodontal health and metabolic profile and consequently prevent negative gestational outcomes. Trial registration NCT, NCT03148483. Registered on May 11, 2017.

Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial

The Lancet ◽  
2009 ◽  
Vol 374 (9705) ◽  
pp. 1909-1916 ◽  
Author(s):  
Clare L Cutland ◽  
Shabir A Madhi ◽  
Elizabeth R Zell ◽  
Locadiah Kuwanda ◽  
Martin Laque ◽  
...  
Keyword(s):  
South Africa ◽  
Randomised Controlled Trial ◽  
Vertical Transmission ◽  
Pathogenic Bacteria ◽  
Controlled Trial ◽  
Randomised Controlled

Postpartum use of oxytocin and volume of placental transfusion: a randomised controlled trial

2019 ◽  
Vol 105 (1) ◽  
pp. 14-17
Author(s):  
Nestor E Vain ◽  
Daniela S Satragno ◽  
Juan Esteban Gordillo ◽  
Ariel L Fernandez ◽  
Guillermo Carrolli ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Umbilical Cord ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Newborn Infants ◽  
Term Infants ◽  
Cord Clamping ◽  
Group 2 ◽  
Randomised Controlled ◽  
Group 1

ObjectiveTo assess whether oxytocin administered before clamping the umbilical cord modifies the volume of placental transfusion.DesignRandomised controlled trial.MethodsMothers of term infants born vigorous by vaginal delivery with informed consent provided in early labour were randomly assigned to oxytocin (10 IU) given intravenously within 15 s of birth (group 1) or after clamping the umbilical cord 3 min after delivery (group 2). Soon after birth, all infants were weighed using a 1 g precision scale and subsequently placed on the mother’s abdomen or chest. At 3 min, in both groups, the cord was clamped and cut, and the weight was again obtained. The primary outcome (volume of placental transfusion) was estimated by the difference in weights.Results144 patients were included. There were no differences in the primary outcome: infants in group 1 (n=70) gained a mean weight of 85.9 g (SD 48.3), and in group 2 (n=74) 86.7 g (SD 49.6) (p=0.92). No differences were found in secondary outcomes, including newborns’ haematocrit and bilirubin concentrations and severe maternal postpartum haemorrhage. On the advice of the Data and Safety Monitoring Committee, the trial was stopped due to futility at 25% of the planned sample size.ConclusionsWhen umbilical cord clamping is delayed for 3 min, term newborn infants born vigorous receive a clinically significant placental transfusion which is not modified by the administration of intravenous oxytocin immediately after birth.Trial registration numberNCT02618499.

scholarly journals Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for Hospitalised Patients with Mild or Moderate COVID-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
Nikhil Vergis ◽  
Rachel Phillips ◽  
Victoria Cornelius ◽  
Alexia Katsarou ◽  
Taryn Youngstein ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Primary Objective ◽  
Ordinal Scale ◽  
Invasive Ventilation ◽  
Multi Stage ◽  
Hospitalised Patients ◽  
Group 2 ◽  
Randomised Controlled

Abstract The primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Secondary objectives, at 14 and 28 days, are to: · Determine the efficacy of RUX or FOS to reduce mortality · Determine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMO· Determine the efficacy of RUX or FOS to reduce the need for non-invasive ventilation · Determine the efficacy of RUX or FOS to reduce the proportion of participants suffering significant oxygen desaturationDetermine the efficacy of RUX or FOS to reduce the need for renal replacement therapy · Determine the efficacy of RUX and FOS to reduce the incidence of venous thromboembolism · Determine the efficacy of RUX and FOS to reduce the severity of COVID-19 pneumonia [graded by a 9-point modified WHO Ordinal Scale*· Determine the efficacy of RUX or FOS to reduce systemic inflammation· Determine the efficacy of RUX or FOS to the incidence of renal impairment · Determine the efficacy of RUX or FOS to reduce duration of hospital stay · Evaluate the safety of RUX and FOS for treatment of COVID-19 pneumonia.Trial designA multi-arm, multi-stage (3-arm parallel-group, 2-stage) randomised controlled trial that allocates participants 1:1:1 and tests for superiority in experimental arms versus standard of care.

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