Effectiveness of full Pulpotomy compared with Root canal treatment in managing teeth with signs and symptOms indicative of irreversible pulpitis: a protocol for prospectiVE meta-analysis of individual participant data of linked randomised clinical trials (PROVE).

BACKGROUND: Full pulpotomy has been proposed as an alternative to root canal treatment in teeth with signs and symptoms indicative of irreversible pulpitis (IRP), but the evidence is limited, relying on underpowered studies with a high risk of bias. The aim of this study is to conduct a prospective meta-analysis (PMA) of individual participant data of a series of individual randomised trials to provide robust evidence on the clinical and cost-effectiveness of pulpotomy compared with root canal treatment. METHODS: Individual participant data will be obtained from a series of randomised trials designed and conducted by a consortium of multi-national investigators with an interest in vital pulp treatment. These individualised trials will be conducted using a specified protocol, defined outcomes, and outcome measures. Ten parallel-group randomised trials currently being conducted in 10 countries will provide data from more than 500 participants. The primary outcome is a composite measure defined as (1) the absence of pain indicative of IRP, (2) the absence of signs and symptoms indicative of acute or chronic apical periodontitis, and (3) the absence of radiographic evidence of failure including radiolucency or resorption. Individual participant data will be obtained, assessed, and checked for quality by two independent reviewers prior to the PMA. Pooled estimates on treatment effects will be generated using a 2-stage meta-analysis approach. The first stage involves a standard regression analysis in each trial to produce aggregate data on treatment effect estimates followed by an inverse variance weighted meta-analysis to combine these aggregate data and produce summary statistics and forest plots. Cost-effectiveness analysis based on the composite outcome will be undertaken as a process evaluation to evaluate treatment fidelity and acceptability by patients and dentists. RESULTS: The research question and trial protocol were developed and approved by investigators in all 10 sites. All sites use shared resources including study protocols, data collection forms, participant information leaflets, and consent forms in order to improve flow, consistency, and reproducibility. Each site obtained its own Institutional Review Board approval, and trials were registered in appropriate open access platforms. Patient recruitment has started in most sites, as of July 2023. DISCUSSION: PMA offers a rigorous, flexible, and efficient methodology to answer this important research question and provide results with improved generalisability and external validity compared with traditional trials and retrospective meta-analyses. The results of this study will have implications for both the delivery of clinical practice and structured clinical guidelines' development. TRIAL REGISTRATION: PROSPERO CRD42023446809. Registered on 08 February 2023.

Evaluation of Smear Layer Removal and Antimicrobial Efficacy of HybenX Against Enterococcus Faecalis Biofilm.

To evaluate the antibacterial efficacy of HybenX, an endodontic irrigant against Enterococcus faecalis biofilm and determine its efficacy in removal of smear layer. Forty root canals were inoculated with E. faecalis for three weeks, divided into 4 groups and irrigated with: Group1: 5 ml 2.5% sodium hypochlorite; Group2: 5 ml 2% chlorhexidine gluconate; Group3: 5 ml HybenX; Group4: 5 ml distilled water (control). Dentin shavings were collected and plated on agar plates, followed by colony forming unit (CFU) determination. For smear layer removal examination, 30 single rooted teeth were instrumented and divided into 3 groups and treated with: GroupI: 5 ml of 17% EDTA; GroupII:5 ml of HybenX; and GroupIII: 5 ml of distilled water. Samples were then subjected to SEM examination. All irrigants showed a significant reduction in CFUs compared to the control group (P⟨ .001), but none compared to each other. Regarding smear layer removal in the apical third, EDTA removed smear layer more effectively than HybenX (P = .014). HybenX demonstrated good antimicrobial efficacy against E. faecalis biofilm and removed the smear layer effectively in coronal and middle third of the root canal system. HybenX can be considered as a promising irrigating agent in root canal treatment of infected teeth.

Evaluation of Smear Layer Removal Using Different Irrigation Methods In Root Canals.

This study evaluated different irrigation methods in smear layer removal from the root canal walls using maleic acid (MA). Maxillary anterior teeth (N=30, n=10 per group) were decoronated, canals were enlarged with Protaper (size F4) and allocated to three groups: EndoUltra: 2.5 ml of 7% MA was irrigated for 30 s, followed by EndoUltra activation for 30 s; EndoSafe: EndoSafe irrigation system was used for 1 minute using 5 ml of 7% MA; Side-vented needle: 30 gauge needle irrigation was performed for 1 min using 5 ml of 7% MA. After SEM analysis, the inter-examiner reliability was verified using Kendall's Co-efficient and data were analyzed using Pearson Chi-Square test. No statistical significant differences were found between the two examiners (p⟩0.05). In intra-group comparison, needle and EndoSafe irrigation demonstrated significantly better smear layer removal at middle third of the root canal system (p⟨0.05) when compared to apical third. In inter-group comparison, smear layer was minimally removed with needle irrigation. In the apical third, EndoUltra group removed smear layer more effectively. Endosafe needle irrigation in combination with 7% MA removed the smear layer in the root canal at best, while the EndoUltra performed the best at the apical third of the root.

Effects of chelating agent and acids on Biodentine.

BACKGROUND: To evaluate the effect of distilled water, ethylenediaminetetraacetic acid (EDTA), phosphoric acid and maleic acid on Biodentine regarding surface topography, microhardness and push-out bond strength (POBS). METHODS: Fifty-two cylindrical shaped Biodentine specimens were divided into groups: control (distilled water); EDTA (17% EDTA); PA (37% phosphoric acid); and MA (7% maleic acid). Surfaces were evaluated by topographic analysis and Vickers microhardness test. Topographic changes were evaluated qualitatively and microhardness was statistically analyzed by Kruskal-Wallis test. Forty mandibular molars were used to simulate clinical conditions. The crowns were removed and a perforation was created at the furcal floor. The Biodentine was packed into the root perforations and the roots were divided into four groups (DW, EDTA, PA, MA). Samples were stored and subjected to interfacial analysis. POBS data were analyzed by Kruskal-Wallis and Dunn tests. RESULTS: Ethylenediaminetetraacetic acid, MA and PA changed the morphology of the Biodentine surface. PA showed microhardness similar to distilled water (P > 0.05), while MA and EDTA demonstrated reduced values when compared with PA (P < 0.05). PA improved the POBS of Biodentine in comparison with the control. CONCLUSIONS: Changes in the topography, microhardness and POBS of Biodentine are associated with irrigant agent used.

Antimicrobial action of calcium hydroxide, chlorhexidine and their combination on endodontic pathogens.

BACKGROUND: The common recovery of Candida albicans and Enterococcus faecalis from failed root canals of teeth in which previous treatment has failed is notable. These organisms have been shown to be resistant to antimicrobial action of calcium hydroxide but are sensitive to chlorhexidine gluconate. The aim of the present in vitro study was to investigate the antimicrobial efficacy of calcium hydroxide paste, 2% chlorhexidine gel and their combination against Candida albicans and Enterococcus faecalis. METHODS: Inoculae of these organisms were used to make lawn cultures on Sabouraud's dextrose agar and blood agar plates. Wells were prepared with these lawn cultures and filled with calcium hydroxide paste, 2% chlorhexidine gel and their combination. The agar plates were kept overnight for incubation at 37 degrees C and the zone of inhibition was examined after 24 and 72 hours. RESULTS: The results suggest that 2% chlorhexidine gel alone is more effective at 72 hours than calcium hydroxide paste alone or in combination with 2% chlorhexidine gel against both the organisms, even though calcium hydroxide showed better antifungal efficacy against Candida albicans at 24 hours. CONCLUSION: In failed root canal treatments, 2% chlorhexidine gel may be a more effective intracanal medicament than calcium hydroxide paste or their combination against Candida albicans and Enterococcus faecalis.