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Randomized Clinical Trials in Pediatric Dentistry: Application of Evidence-Based Dentistry through the CONSORT Statement

  • Arturo Garrocho-Rangel1
  • Socorro Ruiz-Rodríguez1
  • César Gaitán-Fonseca2
  • Amaury Pozos-Guillén3,*,

1Pediatric Dentistry Postgraduate Program, Faculty of Dentistry, San Luis Potosi University, San Luis Potosí, SLP, México

2Pediatric Dentistry Postgraduate Program Faculty of Dentistry, Zacatecas University, Zacatecas, Zac, México

3Basic Sciences Laboratory, Faculty of Dentistry, San Luis Potosi University, San Luis Potosí, SLP, México

DOI: 10.17796/1053-4625-43.4.1 Vol.43,Issue 4,July 2019 pp.219-230

Published: 01 July 2019

*Corresponding Author(s): Amaury Pozos-Guillén E-mail: apozos@uaslp.mx

Abstract

In order to include appropriate informed decisions on dental therapeutic or preventive procedures in children, Pediatric Dentists should apply the fundamentals of “Evidence-Based Dentistry” (EBD). This oral health approach assists clinicians in understanding and applying the most relevant research published on evidence in the clinical setting when treating their patients. One of the crucial steps of EBD is to critically appraise and use the primary articles about therapy or prevention, namely, Randomized Clinical Trials (RCT), the study design that best addresses the questions related with these clinical areas. The aim of the present paper was to provide the basic concepts and an example of how to critically read and understand articles on RCT studies in Pediatric Dentistry employing the CONSORT statement, a process that involves assessing the reliability of results, risk of bias (internal validity), and applicability of reported clinical findings (external validity).

Keywords

Randomized clinical trials; Pediatric dentistry; Evidence-based dentistry; CONSORT

Cite and Share

Arturo Garrocho-Rangel,Socorro Ruiz-Rodríguez,César Gaitán-Fonseca,Amaury Pozos-Guillén. Randomized Clinical Trials in Pediatric Dentistry: Application of Evidence-Based Dentistry through the CONSORT Statement. Journal of Clinical Pediatric Dentistry. 2019. 43(4);219-230.

References

1. Hewitt M. How to search and critically evaluate research literature. The NIHR RDS for the East Midlands / Yorkshire & the Humber, 2007.

2. Chiappelli F, Cajulis OS. The logic model for evidence-based clinical decision making in dental practice. J Evid Dent Pract; 9: 206–110, 2009.

3. Ajaj RA, Barkhordarian A, Phi L, Giroux A, Chiapelli F. Evidence-based dentistry: The next frontier in translational and transnational dental practice. Dent Hypotheses; 2: 55–62, 2011.

4. Sathorn C, Parashos P. Questions and answers in evidence-based dentistry. Brit Dent J; 203: 309–319, 2007.

5. 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;146: 42–49, 2015.

6. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomized controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev; 11: MR000030, 2012.

7. Kwok V, Caton JG, Polson AM, Hunter PG. Application of evidence-based dentistry: From research to clinical periodontal practice. Periodontology 2000; 59: 61–74, 2012.

8. Hua F, Deng L, Kau CH, Jiang H, He H, Walsh T. Reporting quality of randomized controlled trial abstracts: Survey of leading general dental journals. J Am Dent Assoc; 146: 669–678, 2015.

9. 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; 145: 1105–1107, 2014.

10. Henschel AD, Rothenberger LG, Boos J. Randomized clinical trials in children–Ethical and methodological issues. Curr Pharm Des; 16: 2407–2415, 2010.

11. Heasman PA, Macpherson LE, Haining SA, Breckons M. Clinical research in primary dental care. Brit Den J; 219: 159–163, 2015.

12. Jadad AR, Enkin MW. Randomized controlled trials: Questions, answers and musings. 2nd. Ed. Blackwell Publishing (BMJ Books), 2007.

13. Maia LC, Antonio AG. Systematic reviews in dental research. A guideline. J Clin Pediatr Dent; 37: 117–124, 2012.

14. Malekafzali B, Shekarchi F, Asgary S. Treatment outcomes of pulpotomy in primary molars using two endodontic biomaterials. A 2-year randomised clinical trial. Eur J Paediatr Dent; 12: 189–193, 2011.

15. Alessandri Bonetti G, Zanarini M, Incerti-Parenti S, Marini I, Gatto MR. Preventive treatment of ectopically erupting maxillary permanent canines by extraction of deciduous canines and first molars: A randomized clinical trial. Am J Orthod Dentofacial Orthop; 139: 316–323, 2011.

16. Hutcheson C, Seale NS, McWhorter A, Kerins C, Wright J. Multi-surface composite vs stainless steel crown restorations after mineral trioxide aggregate pulpotomy: A randomized controlled trial. Pediatr Dent; 34: 460–467, 2012.

17. Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res; 91: 847–852, 2012.

18. Fernández CC, Martínez SS, Jimeno FG, Lorente Rodríguez AI, Mercadé M. Clinical and radiographic outcomes of the use of four dressing materials in pulpotomized primary molars: a randomized clinical trial with 2-year follow-up. Int J Paediatr Dent; 23: 400–407, 2013.

19. Celik B, Ataç AS, Cehreli ZC, Uysal S. A randomized trial of mineral trioxide aggregate cements in primary tooth pulpotomies. J Dent Child (Chic); 80: 126–132, 2013.

20. Hilton TJ, Ferracane JL, Mancl L; Northwest Practice-based Research Collaborative in Evidence-based Dentistry (NWP). Comparison of CaOH with MTA for direct pulp capping: a PBRN randomized clinical trial. J Dent Res; 92: 16S–22S, 2013.

21. Ruby JD, Cox CF, Mitchell SC, Makhija S, Chompu-Inwai P, Jackson J. A randomized study of sodium hypochlorite versus formocresol pulpotomy in primary molar teeth. Int J Paediatr Dent; 23: 145–152, 2013.

22. Çalış AS, Cagiran E, Efeoglu C, Ak AT, Koca H. Lidocaine versus mepivacaine in sedated pediatric dental patients: randomized, prospective clinical study. J Clin Pediatr Dent; 39: 74–78, 2014.

23. Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel. J Appl Oral Sci; 22: 307–313, 2014.

24. Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingström P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res; 93: 59S–65S, 2014.

29. Armijo-Olivo S, Gazzi-Macedo L, Caroline-Gadotti I, Fuentes J, Stanton T, Magee DJ. Scales to assess the quality of randomized controlled trials: A systematic review. Phys Ther; 88: 156–175, 2008.

25. Hesse D, Bonifácio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health; 14: 58, 2014.

26. Cortés-Dorantes N, Ruiz-Rodríguez MS, Karakowsky-Kleiman L, Garrocho-Rangel JA, Sánchez-Vargas LO, Pozos-Guillén AJ. Probiotics and their effect on oral bacteria count in children: A pilot study. Eur J Paediatr Dent; 16: 56–60, 2015.

27. Pani SC, Dimashkieh M, Mojaleed F, Al Shammery F. The role of an occlusal template during the placement of preformed metal crowns in children under general anaesthesia: a randomised control trial. Eur Arch Paediatr Dent; 16: 461–466, 2015.

28. Kiriakou J, Pandis N, Madianos P, Polychronopoulou A. Developing evidence-based dentistry skills: How to interpret randomized clinical trials and systematic reviews. Prog Orthod; 15: 58–65, 2014.

30. Young JM, Solomon JM. How to critically appraise an article. Nat Rev Gastroenterol Hepatol; 6: 82–91, 2009.

31. Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomized trials. Brit Med J; 343: d5928, 2011.

32. Jadad AR, Moore A, Carrol D, Jenkinson C, Reynolds DJM, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Controlled Clin Trials; 17: 1–2, 1996.

33. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomized trials. Brit Med J; 340: c869, 2010.

34. Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics. 2nd. ed. Appleton & Lange, 1994.

35. Pandis N, Fleming PS, Hopewell S, Altman DG. The CONSORT Statement: Application within and adaptations for orthodontic trials. Am J Orthod Dentofacial Orthop; 147: 663–679, 2015.

36. Phi L, Ramchandani MH, Brant XMC, Oluwadara O, Polinovsky O, Moradi D, et al. Expanding the Grading of Recommendations Assessment, Development, and Evaluation (Ex-GRADE) for evidence-based recommendations: Validation study. Open Dent J; 6: 31–40, 2012.

37. Tiruvoipati R, Balasubramanian P, Atturu G, Peek GJ, Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward. J Clin Thorac Cardiovasc Surg; 132: 233–240, 2006.

38. Savovíc J, Weeks L, Sterne JAC, Tumer L, Altman DG, Moher D, Higgins PT. Evaluation of the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation. Syst Rev; 3: 37–48, 2014.

39. Xiao L, Hu J, Zhang L, Shang H. Endorsement of CONSORT by Chinese medical journals: A survey of “Instructions to Authors”. Chin J Integr Med; 20: 510–515, 2014.

40. Crespo S, Cortes O, García C, Perez L. Comparison between rotary and manual instrumentation in primary teeth. J Clin Pediatr Dent; 32: 295–298, 2008.

41. Katge F, Patil D, Poojari M, Pimpale J, Shitoot A, Rusawat B. Comparison of instrumentation time and cleaning efficacy of manual instrumentation, rotary systems and reciprocating systems in primary teeth: an in vitro study. J Indian Soc Pedod Prev Dent; 32: 311–316, 2014.

42. Subramaniam P, Girish Babu KL, Tabrez TA. Effectiveness of rotary endodontic instruments on smear layer removal in root canals of primary teeth: A scanning electron microscopy study. J Clin Pediatr Dent; 40: 141–146, 2016.

43. Ochoa-Romero T, Méndez-González V, Flores-Reyes H, Pozos-Guillén AJ. Comparison between rotatory and manual techniques on duration of instrumentation and obturation times in primary teeth. J Clin Pediatr Dent; 36: 359–364, 2011.

44. Needleman I, Clarckson J, Wothington H. A practitioner’s guide to developing critical appraisal skills. Am J Dent Assoc; 144: 527–530, 2013.

45. Pandis N, Polychronopoulou A, Eliades T. Sample size estimation: An overview with applications to orthodontic clinical trial designs. Am J Orthod Dentofacial Orthop; 140: e141–e146, 2011.

46. Faber J, Fonseca LM. How sample size influences research outcomes. Dent Press J Orthod; 19: 27–29, 2014.

47. Krithikadatta J, Valarmathi S. Research methodology in dentistry: Part II– The relevance of statistics in research. J Conserv Dent; 15: 206–201, 2012.

48. Hannigan A, Lynch CD. Statistical methodology in oral and dental research: Pitfalls and recommendations. J Dent; 41: 385–392, 2013.

49. Preshaw PM. Critical issues in clinical periodontal research. Periodontology 2000; 59: 7–13, 2012.

50. Kurshid A, Sahai H. Statistics in dental research and journals: A review and a bibliography. Stats Applic; 8: 787–809, 1996.

51. Tu Yu-Kang, Gilthorpe MS. Key statistical and analytical issues for evaluating treatment effects in periodontal research. Periodontology 2000; 59: 75–88, 2012.

52. Petrie A, Bulman JS, Osborn JF. Further statistics in dentistry Part 3: Clinical trials 1. Brit Dent J; 193: 495–498, 2002. 53. Greenstein G. Clinical versus statistical significance as they relate to the efficacy of periodontal therapy. J Am J Dent Assoc; 134: 583–591, 2003.

54. Hujoel PP. Levels of clinical significance. J Evid Base Dent Pract; 4: 32–36, 2004.

55. Khalique N. Informed consent: The drawing of a new era. Brit J Oral Maxillofac Surg; 53: 479–484, 2015.

56. Pandis N, Polychronopoulou A, Eliades T. An assessment of quality characteristics of randomized control trials published in dental journals. J Dent; 38: 713–721, 2010.

57. Greenhalgh T. How to read a paper: The basics of Evidence-based medicine. 1st ed. Wiley-Blackwell (BMJ Books), 2010.

58. Lucena C, Souza EM, Voinea GC, Pulgar R, Valderrama MJ, De-Deus G. A quality assessment of randomized controlled trials reports in endodontics. Int Endod J; 50: 237–250, 2017.

59. Kumar S, Mohammad H, Vora H, Kar K. Reporting quality of randomized controlled trials of periodontal diseases in journal abstracts – A cross-sectional survey and bibliometric analysis. J Evid Based Dent Pract; 18: 130–141, 2018.

60. Borrelli MR, Farwana R, Andrew TW, Chicco M, Abukhder M, Mobarak D, Thavayogan R, Agha R, Pidgeon TE. Assessing the compliance of randomized controlled trials published in craniofacial surgery journals with the CONSORT statement. J Craniofac Surg; 30: 96–104, 2019.

61. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, Backus J. Data sharing statements for clinical trials: A requirement of the International Committee of Medical Journal Editors. J Am Med Assoc; 317: 2491–2492, 2017.

62. Grant S, Mayo-Wilson E, Montgomery P, MacDonald G, Michie S, Hopewell S, Moher D. CONSORT-SPI 2018 explanation and elaboration: Guidance for reporting social and psychological intervention trials. Trials; 19: 406–423, 2018.

63. Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: Extension checklist for reporting within person randomised trials. Brit J Dermatol; 2019 (in press).

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