Response from Professor Bretz

July 21, 2017 | Autor: Walter A Bretz | Categoria: Dentistry
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LETTERS

TO THE

EDITOR

Response to Bretz Review J Evid Base Dent Pract 2011;11:194-195 Dear Dr Newman: We are writing this letter to express our concerns with the recently published analysis of our Journal of the American Dental Association publication. We would like to have the opportunity to publish this letter in your journal in response to the article review by Dr Bretz. Our clinical trial appropriately investigated the 2-year effect of subantimicrobial dose doxycycline (SDD) versus placebo when added to the standard of care, namely, regular periodontal maintenance and dietary supplementation with calcium and vitamin D, for the targeted patient population. The target population of postmenopausal women with osteopenia and moderate to advanced chronic periodontitis has, by definition, oral and systemic bone loss as well as clinical attachment loss. It is not ethical to deny the standard of care for these women and investigate the effect of SDD versus placebo without the concomitant use of regular periodontal maintenance and dietary supplementation with calcium and vitamin D. Therefore, the chosen design, to randomize subjects to receive either SDD plus regular periodontal maintenance and dietary supplementation with calcium and vitamin D or placebo plus regular periodontal maintenance and dietary supplementation with calcium and vitamin D, is a clinically relevant question. Furthermore, the only difference between the randomized treatment arms is the addition of SDD or placebo to the standard of care. Therefore, the sole effect of SDD, when added to the standard of care for this patient population, can be inferred from the clinical trial data. The reviewer’s criticism of not being able to ‘‘determine the sole contribution of SDD on systemic inflammation’’ in this target population would be relevant only if the randomized treatment arms differed by more than a single intervention component. The reviewer assigned a Level of Evidence of ‘‘Level 2: Limited-quality, patient-oriented evidence’’, which is used to describe a ‘‘lower-quality clinical trial’’.1 A ‘‘Level 1: good-quality, patient-oriented evidence assessment’’, which is appropriate for ‘‘high-quality individual randomized controlled trials’’, would have been more appropriate. A ‘‘high-quality’’ randomized controlled trial is defined in

the strength of evidence taxonomy as a trial in which the randomization allocation is concealed, the randomized assignment is blinded, an intention-to-treat analysis is performed, the study has adequate statistical power, and there is adequate follow-up with at least 80% of subjects completing the study.1 These criteria were met by the SDD clinical trial. Details of the design and conduct were reported in the Journal of the American Dental Association manuscript2 and the manuscript reporting the results of the radiographic endpoints from the trial.3 We appreciate the opportunity for this letter to be published in your journal. Sincerely, Jeffrey B. Payne, D.D.S., M.Dent.Sc. University of Nebraska Medical Center College of Dentistry Lorne M. Golub, D.M.D., M.Sc. Stony Brook University School of Dental Medicine Julie A. Stoner, Ph.D. University of Oklahoma Health Sciences Center Jeffrey B. Payne Associate Dean for Research, F. Gene and Rosemary Dixon Endowed Chair in Dentistry, University of Nebraska Medical Center College of Dentistry, 40th and Holdrege, Lincoln, NE 68583-0740 Phone: (402) 472-1318, Fax: (402) 472-6668 [email protected]

REFERENCES 1. Ebell MH, Siwek J, Weiss BD, Woolf SH, Susman J, Ewigman B, et al. Strength of Recommendation Taxonomy (SORT): a patientcentered approach to grading evidence in the medical literature. Am Fam Physician 2004;69(3):548-56. 2. Payne JB, Golub LM, Stoner JA, Lee HM, Reinhardt RA, Sorsa T, et al. The effect of subantimicrobial-dose-doxycycline periodontal therapy on serum biomarkers of systemic inflammation: a randomized, double-masked, placebo-controlled clinical trial. J Am Dent Assoc 2011;142(3):262-73. 3. Payne JB, Stoner JA, Nummikoski PV, Reinhardt RA, Goren AD, Wolff MS, et al. Subantimicrobial dose doxycycline effects on alveolar bone loss in post-menopausal women. J Clin Periodontol 2007;34(9): 776-87. http://dx.doi.org/10.1016/j.jebdp.2012.03.001

Response from Professor Bretz J Evid Base Dent Pract 2012;12:178-179 1532-3382/$36.00 Ó 2012 Elsevier Inc. All rights reserved.

We respectfully submit our assessment of Dr Payne’s response letter. At the very beginning of the

JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE

Commentary section, I state ‘‘This adequately conducted randomized, double-blind, placebo-controlled trial that followed Consolidated Standards of Reporting Trials guidelines is a supplement project of a main trial looking at the effects of SDD periodontal therapy on alveolar bone loss and on periodontal parameters,’’ thus acknowledging the high caliber of the trial. Unfortunately, the conclusions of the trial are based on a combination of therapies (and not SDD alone) that cannot be extrapolated to the general population and, as such,

Volume 12, Number 3

cannot be used to modify the standard of care, hence the level of evidence that was attributed to the study. Walter A. Bretz Associate Professor, New York University, College of Dentistry, Room 1005, 345 East 24th Street, New York, NY 10010 Phone: 212-9989914, Fax: 212-9953994 [email protected] http://dx.doi.org/10.1016/j.jebdp.2012.03.002

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