Preferred Reporting Items for Animal Studies in Endodontology: a development protocol

Abstract

The regulated use of animals in endodontic research is often necessary to investigate the biological mechanisms of endodontic diseases and to measure the preclinical efficacy, biocompatibility, toxicology and safety of new treatments, biomaterials, sealers, drugs, disinfectants, irrigants, devices and instruments. Animal testing is most crucial in situations when research on humans is not ethical, practical or has unknown health risks. Currently, there is a wide variability in the quality of manuscripts that report the results of animal studies. Towards the goal of improving the quality of publications, guidelines for preventing disability, pain, and suffering to animals, and enhanced reporting requirements for animal research have been developed. These guidelines are referred to as Animals in Research: Reporting In Vivo Experiments (ARRIVE). Henceforth, causing any form of animal suffering for research purposes is not acceptable and cannot be justified under any circumstances. The present report describes a protocol for the development of welfare and reporting guidelines for animal studies conducted in the specialty of Endodontology: the Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) guidelines. The PRIASE guidelines will be developed by adapting and modifying the ARRIVE guidelines and the Clinical and Laboratory Images in Publication (CLIP) principles. The development of the new PRIASE guidelines will include a five‐step consensus process. An initial draft of the PRIASE guidelines will be developed by a steering committee. Each item in the draft guidelines will then be evaluated by members of a PRIASE Delphi Group (PDG) for its clarity using a dichotomous scale (yes or no) and suitability for its inclusion using a 9‐point Likert scale. The online surveys will continue until each item achieves this standard, and a set of items are agreed for further analysis by a PRIASE Face‐to‐face Consensus Meeting Group (PFCMG). Following the consensus meeting, the steering committee will finalize and confirm the PRIASE guidelines taking into account the responses and comments of the PFCMG. The PRIASE guidelines will be published and disseminated internationally and updated periodically based on feedback from stakeholders.

Histomorphometric and immunohistochemical study shows that tricalcium silicate cement associated with zirconium oxide or niobium oxide is a promising material in the periodontal tissue repair of rat molars with perforated pulp chamber floors

“…Efforts were made to reduce the number of animals; in all experimental period, animal suffering was avoided with daily monitoring in accordance with Brazilian national law and PRIASE guidelines (Nagendrababu et al . 2019).…”

“…The protocol of this research was approved by Ethical Committee for Animal Research of Araraquara Dental School, UNESP, Brazil (CEUA # 27/2014). Efforts were made to reduce the number of animals; in all experimental period, animal suffering was avoided with daily monitoring in accordance with Brazilian national law and PRIASE guidelines (Nagendrababu et al 2019).…”

Preferred Reporting Items for study Designs in Endodontology (PRIDE): Guiding authors to produce high.quality manuscripts

“…The protocols for how the reporting guidelines were developed for case reports, clinical trials, animal studies, laboratory studies, and observational studies have been published in the International Endodontic Journal. [10][11][12][13][14] For each study design, the steering committee developed an initial draft checklist and a flowchart by combining and modifying the existing generic guidelines (e.g., CARE, CONSORT) and the CLIP principles. [8] In addition, as a result of discussion, several new items were added to each draft checklist.…”

“…• Case reports: Preferred Reporting Items for Case reports in Endodontics (PRICE) [11] • Randomized clinical trials: Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) [12] • Laboratory studies: Preferred Reporting Items for Laboratory studies in Endodontology (PRILE) [13] • Animal studies: Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) [14] • Observational studies: Preferred Reporting items for OBservational studies in Endodontics (PROBE). [10]…”

Preferred Reporting Items for study Designs in Endodontology (PRIDE): guiding authors to identify and correct reporting deficiencies in their manuscripts prior to peer review

“…Under the umbrella of PRIDE, there are currently four reporting guidelines being developed, each focusing on a specific study design: Case reports: Preferred Reporting Items for Case reports in Endodontics (PRICE; Nagendrababu et al ); Randomized clinical trials; Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE; Nagendrababu et al ) Laboratory studies: Preferred Reporting Items for Laboratory studies in Endodontology (PRILE; Nagendrababu et al ). Animal studies: Preferred Reporting Items for Animal Studies in Endodontology (PRIASE; Nagendrababu et al ) …”