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Recommendations for conducting controlled clinical studies of dental restorative materials

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An Erratum to this article was published on 12 February 2008

An Erratum to this article was published on 12 February 2008

Abstract

About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the “Journal of Adhesive Dentistry” and the “Clinical Oral Investigations.” Additionally an extended abstract will be published in the “International Dental Journal” giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.

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References

  1. Antczak-Bouckoms AA, Tulloch JFC, Berkey CS (1990) Split mouth and cross over design in dental research. J Clin Periodontol 17:446–453

    Article  PubMed  Google Scholar 

  2. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC (1992) A comparison of results on meta-analyses of randomized controlled trials and recommendations of clinical experts: treatments for myocardial infarction. J Amer Med Assoc 268:240–248

    Article  Google Scholar 

  3. Bayne SC, Schmalz G (2005) Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig 9(4):209–214

    Article  PubMed  Google Scholar 

  4. Bengel WM (2003) Digital photography and the assessment of therapeutic results after bleaching procedures. J Esthet Restor Dent 15(Suppl 1):S21–S32

    Article  PubMed  Google Scholar 

  5. Blum IR, Schriever A, Heidemann D, Mjör IA, Wilson NH (2003) The repair of direct composite restorations: an international survey of the teaching of operative techniques and materials. Eur J Dent Educ 7(1):41–48

    Article  PubMed  Google Scholar 

  6. Charbeneau GT (1981) Principles and practice of operative dentistry. Lea and Febiger, Philadelphia

    Google Scholar 

  7. Clark TD, Mjör IA (2001) Current teaching of cariology in North Amereican dental schools. Oper Dent 26:412–418

    PubMed  Google Scholar 

  8. Collet D (1994) Modelling survival data in medical research. Chapman and Hall, London

    Google Scholar 

  9. Cox D (1972) Regression models and life tables. J R Stat Soc 34:187–220

    Google Scholar 

  10. Cvar J, Ryge G (1971) Criteria for the clinical evaluation of dental restorative materials. US DHEW Document, US Public Health Service 790244, Printing Office, San Francisco, pp 1–42 (and reprinted as Cvar J, Ryge G. Reprint of Criteria for the clinical evaluation of dental restorative materials. Clin Oral Invest 2005(9):215–252

    Google Scholar 

  11. Elderton RJ (1993) Overtreatment with restorative dentistry: When to intervene? Int Dent J 43:17–24

    PubMed  Google Scholar 

  12. Espelid I, Tveit AB, Erickson RL, Keck SC, Glasspoole EA (1991) Radiopacity of restorations and detection of secondary caries. Dent Mater 7(2):114–117

    Article  PubMed  Google Scholar 

  13. EU (1993) Council directive concerning medical devices. Directive 93/42 EEC

  14. Fitzgerald RJ, Adams BO, Davis ME (1994) A microbiological study of recurrent dentinal caries. Caries Res 28(6):409–415

    Article  PubMed  Google Scholar 

  15. Gaengler P, Hoyer I, Montag R, Gaebler P (2004) Micromorphological evaluation of posterior composite restorations - a 10-year report. J Oral Rehabil 31(10):991–1000

    Article  PubMed  Google Scholar 

  16. Going RE (1972) Microleakage around dental restorations: a summarizing review. J Am Dent Assoc 84(6):1349–1357

    PubMed  Google Scholar 

  17. Goldberg AJ (1990) Deterioration of restorative materials and the risk for secondary caries. Adv Dent Res 4:14–18

    PubMed  Google Scholar 

  18. Gordan VV, Shen C, Mjör IA (2004) Marginal gap repair with flowable resin-based composite. Gen Dent 53:390–394

    Google Scholar 

  19. Gordan VV, Shen C, Riley J, Mjör IA (2006a) Two-year clinical evaluation of repair versus replacement of composite restorations. J Esthet Restor Dent 18(3):144–153

    Article  PubMed  Google Scholar 

  20. Gordan VV, Riley J, Blaser PK, Mjör IA (2006b) 2-year clinical evaluation of alternative treatments to replacement of defective amalgam restorations. Oper Dent 31:418–425

    PubMed  Google Scholar 

  21. Hayashi M, Wilson NH (2003) Failure risk of posterior composites with post-operative sensitivity. Oper Dent 28(6):681–688

    PubMed  Google Scholar 

  22. Hayashi M, Tsuchitani Y, Kawamura Y, Miura M, Takeshige F, Ebisu S (2000) Eight-year clinical evaluation of fired ceramic inlays. Oper Dent 25(6):473–481

    PubMed  Google Scholar 

  23. Heintze SD (2007) The correlation between the evaluation of marginal quality and bond strength and their clinical relevance - a systematic review. J Adhes Dent;accepted for publication

  24. Heintze SD, Twetman S (2002) Interdental mutans streptococci suppression in vivo: a comparison of different chlorhexidine regimens in relation to restorative material. Am J Dent 15(2):103–108

    PubMed  Google Scholar 

  25. Heintze SD, Bastos JRM, Roversi MJ (1997) The prevalence of dental caries and fluorosis in 6-to-44-year-olds in 2 Brazilian cities with and without water fluoridation. 6th World Congress on Preventive Dentistry, Cape Town, South Africa

  26. Heintze SD, Müssner R, Reich E (2000) A new method for the clinical evaluation of direct posterior restorations. J Dent Res 79:186 (Abstract No 341)

    Google Scholar 

  27. Hewlett ER, Atchison KA, White SC, Flack V (1993) Radiographic secondary caries prevalence in teeth with clinically defective restorations. J Dent Res 72(12):1604–1608

    PubMed  Google Scholar 

  28. Hickel R, Manhart J (2001) Longevity of restorations in posterior teeth and reasons for failure. J Adhes Dent 3(1):45–64

    PubMed  Google Scholar 

  29. Hickel R, Manhart J, Garcia-Godoy F (2000) Clinical results and new developments of direct posterior restorations. Am J Dent 13(Spec No):41D–54D

    Google Scholar 

  30. ICDAS (2005) Rationale and evidence for the International Caries Detection and Assessment System (ICDAS II). http://www.icdas.org Retrieved July 31, 2006

  31. ISO (1997) Dentistry-Preclinical evaluation of biocompatibility of medical devices used in dentistry-Test methods for dental materials. International Standard:No. 7405

  32. ISO (2000) Dentistry - Polymer-based filling, restorative and luting materials. International Standard No. 4049

  33. ISO (2003) Dental materials-Testing of adhesion to tooth structure. Technical Specification:No. 11405

  34. Kersten S, Lutz F, Besek M (1999) Zahnfarbene adhäsive Füllungen im Seitenzahnbereich Zürich: Eigenverlag PPK

  35. Kidd EA (1990) Caries diagnosis within restored teeth. Adv Dent Res 4:10–13

    PubMed  Google Scholar 

  36. Kidd EA, Beighton D (1996) Prediction of secondary caries around tooth-colored restorations: a clinical and microbiological study. J Dent Res 75(12):1942–1946

    Article  PubMed  Google Scholar 

  37. Kidd EA, Joyston-Bechal S, Beighton D (1995) Marginal ditching and staining as a predictor of secondary caries around amalgam restorations: a clinical and microbiological study. J Dent Res 74(5):1206–1211

    PubMed  Google Scholar 

  38. Köhler B, Rasmusson CG, Odman P (2000) A five-year clinical evaluation of Class II composite resin restorations. J Dent 28:111–116

    Article  PubMed  Google Scholar 

  39. Krasse B (1989) Prediction and prevention of recurrent caries based on microbiological assays. In: Anusavice KJ (ed) Quality evaluation of dental restorations. Quintessence, Chicago, pp. 199–208

    Google Scholar 

  40. Manhart J, Hickel R (2001) Longevity of restorations. In: Wilson HF, Roulet J-F, Fuzzi M (eds) Advances in operative dentistry-Challenges of the future. Vol 2. Quintessence, Chicago, pp. 237–304

    Google Scholar 

  41. Manhart J, Chen H, Hamm G, Hickel R (2004) Buonocore memorial lecture. Review of the clinical survival of direct and indirect restorations in posterior teeth of the permanent dentition. Oper Dent 29(5):481–508

    PubMed  Google Scholar 

  42. Matthews DE, Farewell VT (1996) Using and understanding medical statistics. Karger, Basel

    Google Scholar 

  43. Merrett MC, Elderton RJ (1984) An in vitro study of restorative dental treatment decisions and dental caries. Br Dent J 157(4):128–133

    Article  PubMed  Google Scholar 

  44. Mjör IA (1985) Frequency of secondary caries at various anatomical locations. Oper Dent 10(3):88–92

    PubMed  Google Scholar 

  45. Mjör IA (1998) The location of clinically diagnosed secondary caries. Quintessence Int 29(5):313–317

    PubMed  Google Scholar 

  46. Mjör IA (2005) Clinical diagnosis of recurrent caries. J Am Dent Assoc 136(10):1426–1433

    PubMed  Google Scholar 

  47. Mjör IA, Gordan VV (2002) Failure, repair, refurbishing and longevity of restorations. Oper Dent 27(5):528–534

    PubMed  Google Scholar 

  48. Mjör IA, Haugen E (1976) Clinical evaluation of amalgam restorations. Scand J Dent Res 84:333–337

    PubMed  Google Scholar 

  49. Mjör IA, Qvist V (1997) Marginal failures of amalgam and composite restorations. J Dent 25:25–30

    Article  PubMed  Google Scholar 

  50. Mjör IA, Toffenetti F (2000) Secondary caries: a literature review with case reports. Quintessence Int 31(3):165–179

    PubMed  Google Scholar 

  51. Moher D, Jones A, Lepage L (2001a) Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285(15):1992–1995

    Article  PubMed  Google Scholar 

  52. Moher D, Schulz KF, Altman D (2001b) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285(15):1987–1991

    Article  PubMed  Google Scholar 

  53. Mjör IA, Gordan VV, Abu-Hanna A, Gilbert GH (2005) Research in general dental practice. Acta Odontol Scand 63(1):1–9

    PubMed  Google Scholar 

  54. Moncado G, Martin J, Fernandez E, Vildosola P, Camano C, Mjör IA, Gordan VV (2006) Alternative treatments for resin based composite and amalgam restorations with marginal defects: 12-month clinical trial. Gen Dent 54:314–318

    Google Scholar 

  55. Mühlemann HR, Son S (1971) Gingival sulcus bleeding-a leading symptom in initial gingivitis. Helv Odontol Acta 15(2):107–113

    PubMed  Google Scholar 

  56. Noack MJ, Van Meerbeek B, Roulet JF, Lambrechts P (1995) Marginal behavior of 10 different tooth-colored inlay systems in vivo. J Dent Res (Spec Iss) 74:165 (Abstract 1227)

    Google Scholar 

  57. Opdam NJ, Feilzer AJ, Roeters JJ, Smale I (1998a) Class I occlusal composite resin restorations: in vivo post-operative sensitivity, wall adaptation, and microleakage. Am J Dent 11(5):229–234

    PubMed  Google Scholar 

  58. Opdam NJ, Roeters FJ, Feilzer AJ, Smale I (1998b) A radiographic and scanning electron microscopic study of approximal margins of Class II resin composite restorations placed in vivo. J Dent 26(4):319–327

    Article  PubMed  Google Scholar 

  59. Opdam NJ, Roeters FJ, Feilzer AJ, Verdonschot EH (1998c) Marginal integrity and postoperative sensitivity in Class 2 resin composite restorations in vivo. J Dent 26(7):555–562

    Article  PubMed  Google Scholar 

  60. Owen R (1982) Reader bias. JAMA 247(18):2533–2534

    Article  PubMed  Google Scholar 

  61. Özer L (1997) The relationship between gap size, microbial accumulation and the structural features of natural caries in extracted teeth with class II amalgam restorations: Thesis, University of Copenhagen

  62. Pallesen U, Qvist V (2003) Composite resin fillings and inlays. An 11-year evaluation. Clin Oral Investig 7(2):71–9. Epub 2003 May 10

    Article  PubMed  Google Scholar 

  63. Perry R, Kugel G, Kunzelmann KH, Flessa HP, Estafan D (2000) Composite restoration wear analysis: conventional methods vs. three-dimensional laser digitizer. J Am Dent Assoc 131(10):1472–1477

    PubMed  Google Scholar 

  64. Peschke A, Heintze SD, Rheinberger V (2003) Clinical evaluation of large posterior composite restorations bonded with a new self-etching adhesive system: 6-month results. J Dent Res(Spec Iss B):195 (Abstract No.1468)

  65. Peschke A, Heintze SD, Roulet JF (2005) Comparison of two impression methods for clinical wear measurement. J Dent Res(Spec Iss B) 84(Abstract No 350(Continental European and Scandinavian Divisions) (http://www.dentalresearch.org)

  66. Peschke A, Heintze SD, Roulet JF (2007) Two-year clinical evaluation and wear analysis of posterior composite restorations. J Den Res 86 (Spec Issue A):Abstract No. 230

  67. Peumans M, Van Meerbeek B, Asscherickx K, Simon S, Abe Y, Lambrechts P, Vanherle G (2001) Do condensable composites help to achieve better proximal contacts? Dent Mater 17:533–541

    Article  PubMed  Google Scholar 

  68. Rathke A, Heintze SD (2001) Prospective clinical trial on a posterior composite with a one-bottle adhesive. J Dent Res 80:1282 (Abstract No 114)

    Google Scholar 

  69. Roulet JF, Reich T, Blunck U, Noack M (1989) Quantitative margin analysis in the scanning electron microscope. Scanning Microsc 3(1):147–159

    PubMed  Google Scholar 

  70. Sarrett DC (2005) Clinical challenges and the relevance of materials testing for posterior composite restorations. Dent Mater 21(1):9–20

    Article  PubMed  Google Scholar 

  71. Saxer UP, Mühlemann HR (1975) Motivation und Aufklärung. Schweiz Mschr Zahnheilk 85:905–909

    Google Scholar 

  72. Schmidlin P, Hoffer E, Lutz F (2002) Evaluation of published clinical studies for reproducibility, comparability and adhesrence to evidence-based methods. Am J Dent 15:26–30

    Google Scholar 

  73. Shen C, Mondragon E, Gordan VV, Mjör IA (2004) The effect of mechanical undercut on the strength of composite repair. J Amer Dent Assoc 135:1406–1412

    Google Scholar 

  74. Shen C, Speigel J, Mjör IA (2006) Repair strength of dental amalgams. Oper Dent 31:122–126

    PubMed  Google Scholar 

  75. Shen C, Mondragon E, Mjör IA (2007) Effect of size of defect on the repair of amalgam. Quintessence Int (in press)

  76. Silness L, Löe H (1964) Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand 22:121–135

    Article  PubMed  Google Scholar 

  77. Smales RJ, Hawthorne WS (2004) Long-term survival of repaired amalgams, recemented crowns and gold castings. Oper Dent 29(3):249–253

    PubMed  Google Scholar 

  78. Söderholm K-JM, Antonson DE, Fischlschweiger W (1989) Correlation between marginal discrepancies at the amalgam/tooth interface and recurrent caries. In: Anusavice KJ (ed) Quality evaluation of dental restorations. Quintessence Publ., Chicago, pp. 95–108

    Google Scholar 

  79. Söderholm KJ, Roberts MJ, Antonson DE, Anusavice KJ, Mauderli AP, Sarrett DC, Warren JW (1992) Visual and profilometric wear measurements. Acta Odontol Scand 50(2):121–127

    Article  PubMed  Google Scholar 

  80. SSO (2000) Qualitätsleitlinien in der Zahnmedizin Bern: SSO

  81. Svanberg M, Mjör IA, Ørstavik D (1990) Mutans streptococci in plaque from margins of amalgam, composite, and glass-ionomer restorations. J Dent Res 69(3):861–864

    PubMed  Google Scholar 

  82. Taylor DF, Bayne SC, Sturdevant JR, Wilder AD (1989) Comparison of direct and indirect methods for analyzing wear of posterior composite restorations. Dent Mater 5(3):157–160

    Article  PubMed  Google Scholar 

  83. Tveit AB, Espelid I, Erickson RL, Glasspoole EA (1991) Vertical angulation of the X-ray beam and radiographic diagnosis of secondary caries. Community Dent Oral Epidemiol 19(6):333–335

    Article  PubMed  Google Scholar 

  84. Vanherle G, Hickel R (2007) In vivo testing of anterior filling materials. Eurocondensor Vol 9(1):16–20

    Google Scholar 

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An erratum to this article can be found at http://dx.doi.org/10.1007/s00784-007-0168-2

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Hickel, R., Roulet, JF., Bayne, S. et al. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Invest 11, 5–33 (2007). https://doi.org/10.1007/s00784-006-0095-7

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