Dataset Information

Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol.

ABSTRACT:

Introduction

Various intracanal medicaments have been used in cases of chronic apical periodontitis for appropriate disinfection of the root canal system to eliminate microbes especially from the inaccessible areas. Calcium hydroxide is the most common intracanal medicament available in various forms, but its effectiveness with or without iodoform using microbial culture is unknown. Therefore, our aim is to compare the antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of teeth presenting with chronic apical periodontitis by assessing the bacterial load reduction.

Method and analysis

60 single rooted teeth of patients with diagnosis of chronic apical periodontitis will be selected and the canals debrided chemomechanically. The patients will be randomised into two groups: Calcipex and Metapex. The first sample (S1) for bacterial culture will be taken before placement of intracanal medicament and the second sample (S2) will be taken after 7 days, before final obturation from the canal and sent to lab for culture. Colony-forming unit will be evaluated. Paired t-test will be used to assess difference between antimicrobial efficacies within the group of medicaments. Independent sample t-test will be used to assess antimicrobial efficacies between groups. Level of significance will be kept at 0.05.

Ethics and dissemination

Approval from Aga Khan University Hospital Ethical review committee is taken. Findings will be reported according to the Standard Protocol Items for Randomised Trials guidelines. Research findings will be disseminated through annual reports, peer-reviewed journals and conferences.

Trial registration number

NCT04336709.

SUBMITTER: Motiwala MA

PROVIDER: S-EPMC8296811 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Objectives The aim of this prospective study was to compare the healing of periapical bone between smokers and nonsmokers after root canal therapy. The effects of duration and intensity of smoking on the healing rate of apical periodontitis were analyzed.Materials and methods Fifty-five smokers were included in this study. The control group consisted of healthy nonsmokers who matched the smoker group in age and sex. Only teeth with a favorable periodontal prognosis and adequate coronal restoration were included in the study. The periapical status of treated teeth was assessed using the periapical index system at follow-ups after 6 and 12 months.Statistical analysis The chi-squared test and Mann-Whitney U test were used to assess the changes in periapical index score at baseline and in subsequent time intervals between the two groups examining dichotomized and ordinal data, respectively. Multivariate logistic regression analysis was used to test the association of independent variables age, gender, tooth type, arch type, and smoking index with the outcome variable. The outcome variable was set as the presence versus absence of apical periodontitis.Results The analysis at 12-month follow-up revealed a significantly higher healing rate in control group than in smokers (90.9 vs. 58.2; χ2 = 13.846; p < 0.001). Smokers had significantly higher periapical index scores than the control group (p = 0.024). The multivariate logistic regression analysis demonstrated that an increase in the value of the smoking index significantly increases the risk of apical periodontitis persistence (odds ratio [OR] =7.66; 95% confidence interval [CI]: 2.51-23.28; p < 0.001) for smoking index < 400 and (OR = 9.65; 95% CI: 1.45-64.14; p = 0.019) for smoking index 400 to 799.Conclusion The results from this study show a lower rate of apical periodontitis healing in a group of smokers at 1-year follow-up. Delayed periapical healing seems to be associated with the cigarette smoking exposure.

Project description:IntroductionCo-administration of a diuretic or calcium channel blocker with an ACE inhibitor are both preferred combinations in patients with hypertensive chronic kidney disease (CKD). According to the available evidence, it is still unknown which combination plays a more active role in renal protection. We hypothesised that a combination of fosinopril and benidipine may delay the progression of CKD more effectively than a combination of fosinopril and hydrochlorothiazide (HCTZ).Methods and analysisThis study will be a multicentred, prospective, double-blind, randomised parallel controlled trial for hypertensive CKD patients in China. Patients will be randomised to one of two treatment groups: a combination of benidipine 4-8 mg/day and fosinopril 20 mg/day; or a combination of HCTZ 12.5-25 mg/day and fosinopril 20 mg/day. Patients will be followed up for 24 months after a month's fosinopril run-in. There will be dose-titration after 1 and 2 months. The primary endpoint is changes in estimated glomerular filtration rate (eGFR) from baseline to month 24. Secondary endpoints include changes in home blood pressure (BP), ambulatory BP, proteinuria, urinary albumin/creatinine ratio, and composite renal events in 24 months. Inclusion criteria are: age 18-80 years, non-dialysis CKD patients with eGFR >30 mL/min/1.73 m2, home BP >130 mm Hg systolic or BP >80 mm Hg diastolic at the screening and randomisation, and 24 hour proteinuria <3.5 g. Principal exclusions are hypertensive crisis, transplantation, cancer, severe diabetes complications, hyperkalaemia and severe allergy. The required sample size was 511 patients for detecting a difference in the change of eGFR (one sided α=0.025, power 1-β=0.90).Ethics and disseminationBEAHIT (Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients with Hypertension) was approved by Changzheng Hospital Ethics Committee (CZ-20160504-16). The outcomes will be published in a peer-reviewed journal.Trial registration numberNCT02646397.

Project description:IntroductionChronic neuropathic pain is associated with reduced health-related quality of life and substantial socioeconomic costs. Current research addressing management of chronic neuropathic pain is limited. No review has evaluated all interventional studies for chronic neuropathic pain, which limits attempts to make inferences regarding the relative effectiveness of treatments.Methods and analysisWe will conduct a systematic review of all randomised controlled trials evaluating therapies for chronic neuropathic pain. We will identify eligible trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AMED, HealthSTAR, DARE, PsychINFO and the Cochrane Central Registry of Controlled Trials. Eligible trials will be: (1) enrol patients presenting with chronic neuropathic pain, and (2) randomise patients to alternative interventions (pharmacological or non-pharmacological) or an intervention and a control arm. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible trials and extract information from eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias of eligible studies, recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes we will collect, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate our confidence in treatment effects. When possible, we will conduct: (1) in direct comparisons, a random-effects meta-analysis to establish the effect of reported therapies on patient-important outcomes; and (2) a multiple treatment comparison meta-analysis within a Bayesian framework to assess the relative effects of treatments. We will define a priori hypotheses to explain heterogeneity between studies, and conduct meta-regression and subgroup analyses consistent with the current best practices.Ethics and disseminationWe do not require ethics approval for our proposed review. We will disseminate our findings through peer-reviewed publications and conference presentations.Trial registration numberPROSPERO (CRD42014009212).