Letters to the Editor
J Periodontol • November 2014
do not gain benefit of the treatment measure. For similar reasons, efficacy trials in oral health must terminate at the stage when a large effect size is demonstrated in the presence of acceptable power and confidence. There is much to admire in the current study, and the results are of considerable interest. However, it would have been prudent for the authors to have done this trial with a reduced sample size, as there was a demonstrated ‘‘large’’ effect by the use of alendronate gel in their previous trials.2,8 The use of larger than necessary sample sizes for Phase IV efficacy clinical trials is definitely unethical.
6. Sullivan LM, D’Agostino RB. Robustness of the t test applied to data distorted from normality by floor effects. J Dent Res 1992;71:1938-1943. 7. Armitage P. Interim analysis in clinical trials. Stat Med 1991;10:925-935, discussion 936-937. 8. Sharma A, Pradeep AR. Clinical efficacy of 1% alendronate gel in adjunct to mechanotherapy in the treatment of aggressive periodontitis: A randomized controlled clinical trial. J Periodontol 2012;83:19-26.
Shaju Jacob Pulikkotil, Department of Restorative Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia, and Sonia Nath, Department of Periodontology, Vananchal Dental College and Hospital, Garhwa, Jharkhand, India.
Authors’ Response:
The authors thank Professor Frederick Smales, Department of Restorative Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia, for reviewing their work. The authors report no conflicts of interest related to this letter. REFERENCES 1. Lesaffre E, Garcia Zattera MJ, Redmond C, Huber H, Needleman I; ISCB Subcommittee on Dentistry. Reported methodological quality of split-mouth studies. J Clin Periodontol 2007;34:756-761. 2. Sharma A, Pradeep AR. Clinical efficacy of 1% alendronate gel as a local drug delivery system in the treatment of chronic periodontitis: A randomized, controlled clinical trial. J Periodontol 2012;83:11-18. 3. Loscalzo J. Pilot trials in clinical research: Of what value are they? Circulation 2009;119:1694-1696. 4. Vansant AF. The dilemma of the small sample size. Pediatr Phys Ther 2003;15:145. 5. Rochon J, Gondan M, Kieser M. To test or not to test: Preliminary assessment of normality when comparing two independent samples. BMC Med Res Methodol 2012;12:81.
Submitted March 9, 2013; accepted for publication April 13, 2013. doi: 10.1902/jop.2014.130165
Alendronate is widely used in various bone disorders like osteoporosis, Paget disease, etc. This was the first study evaluating the efficacy of 1% alendronate gel in the treatment of Class II furcation defects. A sample size of six hardly stands any chance in validation of results in any clinical trial. Moreover, considering the complex anatomic morphology of furcation defects, difficulty in plaque control and regeneration in cases of Class II furcation defects, a larger sample size would obviously prove beneficial in validation of results. A.R. Pradeep, Minal Kumari, and Nishanth S. Rao, Department of Periodontics, Government Dental College and Research Institute, Bangalore, India; and Savitha B. Naik, Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Bangalore. The authors report no conflicts of interest related to this letter. Submitted February 25, 2014; accepted for publication February 25, 2014. doi: 10.1902/jop.2014.140136
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J Periodontol • November 2014
do not gain benefit of the treatment measure. For similar reasons, efficacy trials in oral health must terminate at the stage when a large effect size is demonstrated in the presence of acceptable power and confidence. There is much to admire in the current study, and the results are of considerable interest. However, it would have been prudent for the authors to have done this trial with a reduced sample size, as there was a demonstrated ‘‘large’’ effect by the use of alendronate gel in their previous trials.2,8 The use of larger than necessary sample sizes for Phase IV efficacy clinical trials is definitely unethical.
6. Sullivan LM, D’Agostino RB. Robustness of the t test applied to data distorted from normality by floor effects. J Dent Res 1992;71:1938-1943. 7. Armitage P. Interim analysis in clinical trials. Stat Med 1991;10:925-935, discussion 936-937. 8. Sharma A, Pradeep AR. Clinical efficacy of 1% alendronate gel in adjunct to mechanotherapy in the treatment of aggressive periodontitis: A randomized controlled clinical trial. J Periodontol 2012;83:19-26.
Shaju Jacob Pulikkotil, Department of Restorative Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia, and Sonia Nath, Department of Periodontology, Vananchal Dental College and Hospital, Garhwa, Jharkhand, India.
Authors’ Response:
The authors thank Professor Frederick Smales, Department of Restorative Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia, for reviewing their work. The authors report no conflicts of interest related to this letter. REFERENCES 1. Lesaffre E, Garcia Zattera MJ, Redmond C, Huber H, Needleman I; ISCB Subcommittee on Dentistry. Reported methodological quality of split-mouth studies. J Clin Periodontol 2007;34:756-761. 2. Sharma A, Pradeep AR. Clinical efficacy of 1% alendronate gel as a local drug delivery system in the treatment of chronic periodontitis: A randomized, controlled clinical trial. J Periodontol 2012;83:11-18. 3. Loscalzo J. Pilot trials in clinical research: Of what value are they? Circulation 2009;119:1694-1696. 4. Vansant AF. The dilemma of the small sample size. Pediatr Phys Ther 2003;15:145. 5. Rochon J, Gondan M, Kieser M. To test or not to test: Preliminary assessment of normality when comparing two independent samples. BMC Med Res Methodol 2012;12:81.
Submitted March 9, 2013; accepted for publication April 13, 2013. doi: 10.1902/jop.2014.130165
Alendronate is widely used in various bone disorders like osteoporosis, Paget disease, etc. This was the first study evaluating the efficacy of 1% alendronate gel in the treatment of Class II furcation defects. A sample size of six hardly stands any chance in validation of results in any clinical trial. Moreover, considering the complex anatomic morphology of furcation defects, difficulty in plaque control and regeneration in cases of Class II furcation defects, a larger sample size would obviously prove beneficial in validation of results. A.R. Pradeep, Minal Kumari, and Nishanth S. Rao, Department of Periodontics, Government Dental College and Research Institute, Bangalore, India; and Savitha B. Naik, Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Bangalore. The authors report no conflicts of interest related to this letter. Submitted February 25, 2014; accepted for publication February 25, 2014. doi: 10.1902/jop.2014.140136
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