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Research Article| Volume 58, ISSUE 6, P647-651, July 2020

Quality assessment of randomised controlled trials in oral and maxillofacial surgery

  • Author Footnotes
    1 Fax number: +55 51 32137285.
    B. Trevisan
    Footnotes
    1 Fax number: +55 51 32137285.
    Affiliations
    Department of Oral Maxillofacial Surgery, Lutheran University of Brazil, Meridional College, Canoas, Av. Casemiro de Abreu, 205/101, Porto Alegre, RS CEP: 90420001, Brazil
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  • Author Footnotes
    2 Fax number: +55 55 32214753.
    R.D.P. Garcia
    Footnotes
    2 Fax number: +55 55 32214753.
    Affiliations
    Department of Orthodontics, Lutheran University of Brazil, Canoas, Rua Almirante Abreu, 130/702, Porto Alegre, RS CEP: 90420010, Brazil
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  • M.L. Musskopf
    Correspondence
    Correspondence to: 150 Dental Circle Room 3044, Chapel Hill, NC 27514, USA.
    Affiliations
    Department of Periodontology, Lutheran University of Brazil, Canoas, Brazil

    Division of Oral and Craniofacial Health Sciences, Division of Comprehensive Oral Health-Periodontology, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
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  • Author Footnotes
    1 Fax number: +55 51 32137285.
    2 Fax number: +55 55 32214753.

      Abstract

      Randomised controlled trials are the best way to study the evaluation of treatments. We have evaluated the quantity and quality of clinical trials in three of the main journals in the specialty of oral and maxillofacial surgery between January 2010 and December 2016, using a scientometric analysis, and evaluation by the Jadad scale. In this period, 303 randomised controlled trials (5% of the total) were identified; the largest number of studies were from Asia (45%) followed by Europe (32%). The subgroup that concerned most studies was oral surgery. The mean score on the Jadad scale was 3.06 points, which means that 32% of the total studies had a low risk of bias. Studies that declared funding and adherence to Consolidated Standards of Reporting Trials (CONSORT) were given significantly higher scores (p < 0.001) than studies that did not. We conclude that randomised controlled trials in oral maxillofacial surgery have evolved in both quality and quantity since previous surveys were published. The quality of trials was related to the presence of funding and adherence to CONSORT.

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      References

        • Sandhu A.
        The evidence base for oral and maxillofacial surgery: 10-year analysis of two journals.
        Br J Oral Maxillofac Surg. 2012; 50: 45-48
        • Oomens M.A.
        • Heymans M.W.
        • Forouzanfar T.
        Risk of bias in research in oral and maxillofacial surgery.
        Br J Oral Maxillofac Surg. 2013; 51: 913-919
        • Susarla S.M.
        • Mundinger G.S.
        • Swanson E.W.
        • et al.
        What is the quality of the evidence in the craniomaxillofacial surgery literature?.
        J Oral Maxillofac Surg. 2015; 73: 2017-2023
        • Nocini P.F.
        • Verlato G.
        • Frustaci A.
        • et al.
        Evidence-based dentistry in oral surgery: could we do better?.
        Open Dent J. 2010; 4: 77-83
        • Fung E.K.
        • Lore Jr., J.M.
        Randomized controlled trials for evaluating surgical questions.
        Arch Otolaryngol Head Neck Surg. 2002; 128: 631-634
        • Kyzas P.A.
        Evidence-based oral and maxillofacial surgery.
        J Oral Maxillofac Surg. 2008; 66: 973-986
        • Pitak-Arnnop P.
        • Sader R.
        • Rapidis A.D.
        • et al.
        Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials.
        J Craniomaxillofac Surg. 2010; 38: 4-10
        • Walker T.W.
        • Cascarini L.
        • Brennan P.A.
        Educational paper: research in oral and maxillofacial surgery.
        Br J Oral Maxillofac Surg. 2010; 48: 629-632
        • Schulz K.F.
        Assessing allocation concealment and blinding in randomized controlled trials: why bother?.
        Evid Based Nurs. 2001; 4: 4-6
        • Moher D.
        • Pham B.
        • Jones A.
        • et al.
        Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyses?.
        Lancet. 1998; 352: 609-613
        • Moher D.
        • Liberati A.
        • Tetzlaff J.
        • et al.
        Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
        PLoS Med. 2009; 6e1000097
        • Moher D.
        • Hopewell S.
        • Schulz K.F.
        • et al.
        CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.
        Int J Surg. 2012; 10: 28-55
        • Vandenbroucke J.P.
        • von Elm E.
        • Altman D.G.
        • et al.
        Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration.
        PLoS Med. 2007; 4: e297
      1. Howick J, Chalmers I, Glasziou P, et al. Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence. Available from URL: http://www.cebm.net/&2016/05&ocebm-levels-of-evidence Last accessed 27 November 2019.

        • Olivo S.A.
        • Macedo L.G.
        • Gadotti I.C.
        • et al.
        Scales to assess the quality of randomized controlled trials: a systematic review.
        Phys Ther. 2008; 88: 156-175
        • Moher D.
        • Jadad A.R.
        • Nichol G.
        • et al.
        Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists.
        Contr Clin Trials. 1995; 16: 62-73
        • Sinno H.
        • Neel O.F.
        • Lutfy J.
        • et al.
        Level of evidence in plastic surgery research.
        Plast Reconstr Surg. 2011; 127: 974-980
        • Abel U.
        • Koch A.
        The role of randomization in clinical studies: myths and beliefs.
        J Clin Epidemiol. 1999; 52: 487-497
        • Concato J.
        • Shah N.
        • Horwitz R.I.
        Randomized, controlled trials, observational studies, and the hierarchy of research designs.
        N Engl J Med. 2000; 342: 1887-1892
        • Pandis N.
        • Polychronopoulou A.
        • Madianos P.
        • et al.
        Reporting of research quality characteristics of studies published in 6 major clinical dental specialty journals.
        J Evid Based Dent Pract. 2011; 11: 75-83
        • Lee J.S.
        In search of the highest quality: levels of evidence in oral and maxillofacial surgery.
        J Oral Maxillofac Surg. 2014; 72: 2102-2104
        • Begg C.
        • Cho M.
        • Eastwood S.
        • et al.
        Improving the quality of reporting of randomized controlled trials. The CONSORT statement.
        JAMA. 1996; 276: 637-639
        • Moher D.
        • Jones A.
        • Lepage L.
        Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.
        JAMA. 2001; 285: 1992-1995
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
        Ann Intern Med. 2010; 152: 726-732
        • Schulz K.F.
        • Chalmers I.
        • Hayes R.J.
        • et al.
        Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
        JAMA. 1995; 273: 408-412