Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Dec:31 Suppl 1:23-30.
doi: 10.1111/ipd.12743. Epub 2021 Jan 17.

How researchers should select the best outcomes for randomised clinical trials in paediatric dentistry?

Fausto M Mendes  1 , Mariana M Braga  1 , Ana Laura Pássaro  1 , Bruna L P Moro  1 , Raiza Dias Freitas  1 , Thais Gimenez  1   2 , Tamara K Tedesco  2 , Daniela P Raggio  1 , Claudio M Pannuti  1
Affiliations
Review

How researchers should select the best outcomes for randomised clinical trials in paediatric dentistry?

Fausto M Mendes et al. Int J Paediatr Dent. 2020 Dec.

Abstract

Randomised clinical trial (RCT) is the best study design to evaluate the effect of the treatment and preventive healthcare procedures. The effects of the tested treatments on patient's health are compared in terms of outcomes, which are used to evaluate the participants' health changes. However, these outcomes should be relevant for the target population. In that way, RCTs represent the type of primary study design that provides the most reliable evidence to implement therapies into the clinical practice. In this review, an outline of some aspects related to the choice of RCTs' outcomes was presented, focusing on the conduction of relevant trials in Paediatric Dentistry. The importance and necessity of defining a primary outcome were addressed, preferentially a clinically relevant endpoint. The patients should perceive this outcome, and changes in this variable should reflect directly patient's health improvement or impairment. Moreover, considerations about the objective or subjective variables, use of surrogate outcomes, and the increasing tendency to develop core outcome sets were also presented in this review. The main idea of this manuscript is the RCTs must evaluate outcomes relevant to the children's oral health in order to contribute to the implementation of treatments in the evidence-based health practice.

Keywords: clinically relevant outcomes; core outcome sets; paediatric dentistry; randomised clinical trials; surrogate outcomes.

PubMed Disclaimer

References

REFERENCES

    1. Brignardello-Petersen R, Carrasco-Labra A, Glick M, Guyatt GH, Azarpazhooh A. A practical approach to evidence-based dentistry: III: how to appraise and use an article about therapy. J Am Dent Assoc. 2015;146(1):42-49.
    1. Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002;359(9305):515-519.
    1. Brignardello-Petersen R, Carrasco-Labra A, Glick M, Guyatt GH, Azarpazhooh A. A practical approach to evidence-based dentistry: understanding and applying the principles of EBD. J Am Dent Assoc. 2014;145(11):1105-1107.
    1. Gillette J, Balevi B. Simple approaches for establishing an evidence-based dental practice. Dent Clin North Am. 2019;63(1):1-16.
    1. Pannuti CM, Sendyk DI, Graças YT, et al. Clinically relevant outcomes in dental clinical trials: challenges and proposals. Braz Oral Res. 2020;34(supp2):e073.

LinkOut - more resources