Bolla trial

AIM: The aim of this study was to investigate whether treatment with rapamycin plus vildagliptin restores β-cell function in patients with long-standing type 1 diabetes. METHODS: A phase 2, single-center, randomized, double-blind, placebo-controlled study was conducted in long-standing type 1 diabetes patients randomly assigned (1:1:1) to 4 weeks of rapamycin (group 2), 4 weeks of rapamycin plus 12 weeks of vildagliptin (group 3), or double placebo (group 1)...

The study aimed to compare the efficacy of three caries removal techniques-complete caries removal (CCR), selective caries removal (SCR), and stepwise caries removal (SWR)-for deep carious lesions in vital temporary teeth by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Electronic databases (PubMed [MEDLINE], Cochrane Library, EMBASE) were searched for corresponding references up to 31 May 2019. Possible outcomes were pulp exposure, pulpo-periodontal complications, or restorative failures...

BACKGROUND: The importance of local failure (LF) after treatment of high-grade prostate cancer (PCa) with definitive radiotherapy (RT) remains unknown. OBJECTIVE: To evaluate the clinical implications of LF after definitive RT. DESIGN, SETTING, AND PARTICIPANTS: Individual patient data meta-analysis of 992 patients (593 Gleason grade group [GG] 4 and 399 GG 5) enrolled in six randomized clinical trials. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable Cox proportional hazard models were developed to evaluate the relationship between overall survival (OS), PCa-specific survival (PCSS), and distant metastasis (DM)-free survival (DMFS) and LF as a time-dependent covariate...

BACKGROUND: Guidelines in pediatric restorative dentistry recommend the use of preformed pediatric stainless steel crowns (SSCs) in cases of severe tooth decay of at least two surfaces. This clinically effective and safe restorative option is frequently refused by parents for esthetic reasons; they prefer conventional restorations using esthetic filling materials (composites, glass ionomer) if lesion severity limited to two surfaces permits. Recently, manufacturers have proposed esthetic preformed pediatric zirconia crowns (ZCs) but these have been assessed in only two randomized clinical trials (RCT) with follow-ups of 6 and 12 months...

Cognitive impairments are associated with poor outcomes when treating cocaine dependent patients, but behavioral interventions to mitigate this impact have not been developed. In this Stage 1A/1B treatment development study, several compensatory strategies (e.g., content repetition, daily logs, diaries, visual presentation) were combined to create a modified cognitive behavioral therapy (M-CBT) for treating cocaine dependence. Initially, a select group of therapists, neuropsychology experts, and patients were asked to provide input on early drafts of the treatment manual and companion patient workbook...

IMPORTANCE: Androgen deprivation therapy (ADT) improves survival outcomes in patients with high-risk prostate cancer (PCa) treated with radiotherapy (RT). Whether this benefit differs between patients with Gleason grade group (GG) 4 (formerly Gleason score 8) and GG 5 (formerly Gleason score 9-10) disease remains unknown. OBJECTIVE: To determine whether the effectiveness of ADT duration varies between patients with GG 4 vs GG 5 PCa. DESIGN, SETTING, AND PARTICIPANTS: Traditional and network individual patient data meta-analyses of 992 patients (593 GG 4 and 399 GG 5) who were enrolled in 6 randomized clinical trials were carried out...

BACKGROUND: In children, dental caries (tooth decay) is among the most prevalent chronic diseases worldwide. Pulp interventions are indicated for extensive tooth decay. Depending on the severity of the disease, three pulp treatment techniques are available: direct pulp capping, pulpotomy and pulpectomy. After treatment, the cavity is filled with a medicament. Materials commonly used include mineral trioxide aggregate (MTA), calcium hydroxide, formocresol or ferric sulphate.This is an update of a Cochrane Review published in 2014 when insufficient evidence was found to clearly identify one superior pulpotomy medicament and technique...

BACKGROUND: Misoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. The aim of this study was to compare misoprostol vaginal insert (MVI) with misoprostol vaginal tablets (MVT) for induction of labor in term pregnancies. METHODS: In this retrospective cohort study we compared 200 consecutive women induced with 200-μg misoprostol 24-h vaginal insert (Misodel®) with a historical control of 200 women induced with Misoprostol 25-μg vaginal tablets (Cytotec®) every 4-6 h...

A split-mouth randomized clinical trial was carried out to assess the effectiveness of sealants in preventing carious ICDAS (International Caries Detection and Assessment System) 3-6 lesions within a 2-year follow-up. We evaluated the effectiveness of 2 types of resin-based sealants, with and without fluoride, their retention rates, and the caries risk factors related to their outcomes. The study included 663 tooth pairs in 400 children (aged 5-15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1-2 lesions...

Aim: The purpose of this study was to evaluate the clinical performance of Ketac Nano (Ketac™ N100), RMGIC (Fuji Filling™ LC), and Giomer (Beautifil® II) in noncarious cervical lesions (NCCLs). Materials and Methods: One operator restored 120 NCCLs in 20 subjects, with at least two lesions restored with one of the restorative materials: RMGIC (control group), Giomer and Ketac Nano (experimental groups). Two observers evaluated retention, marginal discoloration, marginal adaptation, color match, surface roughness, and postoperative sensitivity using modified USPHS criteria at baseline, 6, and 12 months...

CONTEXT: Current evidence-based management for clinically localised prostate cancer includes active surveillance, surgery, external beam radiotherapy (EBRT) and brachytherapy. The impact of these treatment modalities on quality of life (QoL) is uncertain. OBJECTIVE: To systematically review comparative studies investigating disease-specific QoL outcomes as assessed by validated cancer-specific patient-reported outcome measures with at least 1 yr of follow-up after primary treatment for clinically localised prostate cancer...

STATEMENT OF THE PROBLEM: Hearing impaired children have a problem in understanding and comprehending with dental treatments. Visual language is the sensible answer of how to improve communication with them. PURPOSE: To evaluate the applicability of dental sign language in Hearing impaired children in relieving anxiety during stressful dental treatment by improving their means of communication. MATERIALS AND METHOD: This randomized clinical trial was carried out in the Department of Pedodontics and Preventive Dentistry which included 40 Hearing Impaired children meeting inclusion criteria...

BACKGROUND: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors...

CONTEXT: There is controversy regarding the therapeutic role of pelvic lymph node dissection (PLND) in patients undergoing radical prostatectomy for prostate cancer (PCa). OBJECTIVE: To systematically review the relevant literature assessing the relative benefits and harms of PLND for oncological and non-oncological outcomes in patients undergoing radical prostatectomy for PCa. EVIDENCE ACQUISITION: MEDLINE, MEDLINE In-Process, Embase, and the Cochrane Central Register of Controlled Trials were searched up to December 2015...

BACKGROUND: The foundation for the reconstruction of endodontically-treated teeth can be provided by a metal or a non-metal post and core system but no guidelines exist for choosing one or the other in particular clinical cases. OBJECTIVES: To assess the effectiveness of different post and core systems for the restoration of endodontically-treated teeth. The primary objective of this review was to compare the clinical failure rates of the different types of posts...

The aim of this systematic review was to assess the in vivo scientific evidence regarding the ability of a recently developed light fluorescence device, SoproLife(®) (Sopro-Acteon group, La Ciotat, France) in detecting occlusal carious lesions. The PubMed database was searched for in vivo trials that evaluated the validity of the SoproLife(®) camera for the detection of occlusal carious lesions. Among the 11 articles originally identified with the keyword "Soprolife," only three articles were included. The three included surveys used the International Caries Detection and Assessment System (ICDAS)-II criteria as gold standard for the assessment of SoproLife(®) compared or not to other detection devices (DIAGNOdent(®) and Spectra Caries Detection Aid(®))...

BACKGROUND: Different aesthetic preformed crowns (APC) are proposed to restore decayed and damaged primary teeth because the stainless steel crowns (SSCs) do not satisfy parents concerned about aesthetic. AIM: The objective was to evaluate the clinical effectiveness of all types of APC for restoring primary teeth compared with conventional filling materials or other types of crowns. DESIGN: Relevant articles were searched in electronic databases of PubMed via MEDLINE and the Cochrane central register of controlled trials...

BACKGROUND: Current concepts in conservative dentistry advocate minimally invasive dentistry and pulp vitality preservation. Moreover, complete removal of carious dentin in deep carious lesions often leads to pulp exposure and root canal treatment, despite the absence of irreversible pulp inflammation. For years, partial caries removal has been performed on primary teeth, but little evidence supports its effectiveness for permanent teeth. Furthermore, the recent development of new antibacterial adhesive systems could be interesting in the treatment of such lesions...

AIM: To assess dental practice regarding the use of indirect pulp capping or pulpotomy in children with deep carious lesions approaching the pulp in primary teeth and to compare the efficacy of the two pulp treatments. METHODS: <AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">Systematic review. We searched the Cochrane Library, PubMed via MEDLINE, and EMBASE as well as the reference lists of included reports and ClinicalTrials.gov (for ongoing trials)...

AIM: A split-mouth randomized clinical trial was carried out to assess the effectiveness of a school-based dental sealant (SBDS) program for French children from low-income backgrounds within 3 years of follow-up. The secondary objectives were to determine the risk factors for the occurrence of new carious lesions (ICDAS 3-6) on first permanent molars, to evaluate the effectiveness of the program according to risk factors and to assess sealant retention. METHODS: The study included 276 6- to 7-year old pupils (457 pairs of first permanent molars) from Nice...