Abstract
Clinical trials employ sequential analysis for the ethical and economic benefits it brings. In dentistry, as in other fields, resources are scarce and efforts are made to ensure that patients are treated ethically. The objective of this systematic review was to characterise the use of sequential analysis for clinical trials in dentistry. We searched various databases from 1900 through to January 2008. Articles were selected for review if they were clinical trials in the field of dentistry that had applied some form of sequential analysis. Selection was carried out independently by two of the authors. We included 18 trials from various specialties, which involved many different interventions. We conclude that sequential analysis seems to be underused in this field but that there are sufficient methodological resources in place for future applications.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Whitehead J . Sequential methods in clinical trials. In Handbook of Sequential Analysis. Edited by Ghosh BK, Sen PK. New York: Marcel Dekker; 1991:pp593–611.
Sébille V, Bellissant E . Sequential methods and group sequential designs for comparative clinical trials. Fundam Clin Pharmacol 2003; 17:505–516.
Halpern J, Brown Jr BW . Sequential treatment allocation procedures in clinical trials—with particular attention to the analysis of results for the biased coin design. Stat Med 1986; 5:211–229.
Jennison C, Turnbull BW (Eds). Group Sequential Methods with Applications to Clinical Trials. Boca Raton: Chapman and Hall/CRC; 2000:pp1–19.
Benneyan JC, Lloyd RC, Plsek PE . Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care 2003; 12:458–464.
Gombay E, Hussein A . A class of sequential tests for two-sample composite hypotheses. Can J Stat 2006; 34:217–232.
Todd S, Whitehead A, Stallard N, Whitehead J . Interim analyses and sequential designs in phase III studies. Br J Clin Pharmacol 2001; 51:394–399.
Palmer CR, Rosenberger WF . Ethics and practice: alternative designs for phase III randomized clinical trials. Control Clin Trials 1999; 20:172–186.
Wegscheider K . Advantages and disadvantages of sequential designs. Herzschrittmacherther Elektrophysiol 1998; 9:248–254.
Leroux BG, Mancl LA, DeRouen TA . Group sequential testing in dental clinical trials with longitudinal data on multiple outcome variables. Stat Methods Med Res 2005; 14:591–602.
Armitage P, Stratton IM, Worthington HV . Repeated significance tests for clinical trials with a fixed number of patients and variable follow-up. Biometrics 1985; 41:353–359.
Smith VO, O'Mullane DM . Use of sequential analysis in clinical trials of caries prophylactic agents. J Dent Res 1977; 56 (suppl.):C112–C115.
Imrey PB, Chilton NW . Design and analytic concepts for periodontal clinical trials. J Periodontol 1992; 63:1124–1140.
Petrie A, Bulman JS, Osborn JF . Further statistics in dentistry. Part 4: Clinical trials 2. Br Dent J 2002; 193:557–561.
van der Glas HW, Abbink JH, van der Bilt A, Cadden SW . Analysis of differences between conditioned and control reflex series in EMG recordings. J Neurosci Methods 1995; 58:117–125.
Higgins JPT, Green S (Eds). Cochrane Handbook for Systematic Reviews of Interventions 4.2.6; 2006.
Binnie VI, McHugh S, Jenkins W, Borland W, MacPherson LM . A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study. BMC Oral Health 2007; 7:5.
DeRouen TA, Martin MD, Leroux BG, et al. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial. J Am Med Assoc 2006; 295:1784–1792.
Annane D, Depondt J, Aubert P, et al. Hyperbaric oxygen therapy for radionecrosis of the jaw: a randomized, placebo-controlled, double-blind trial from the ORN96 study group. J Clin Oncol 2004; 22:4893–4900.
Kvist T, Molander A, Dahlén G, Reit C . Microbiological evaluation of one- and two-visit endodontic treatment of teeth with apical periodontitis: a randomized, clinical trial. J Endod 2004; 30:572–576.
Mulshine JL, Atkinson JC, Greer RO, et al. Randomized, double-blind, placebo-controlled phase IIB trial of the cyclooxygenase inhibitor ketorolac as an oral rinse in oropharyngeal leukoplakia. Clin Cancer Res 2004; 10:1565–1573.
Prahl C, Kuijpers-Jagtman AM, van‘t Hof MA, Prahl-Andersen B . A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft). Eur J Oral Sci 2001; 109:297–305.
Kaufman HW, Wolff MS, Winston AE, Triol CW . Clinical evaluation of the effect of a remineralizing toothpaste on dentinal sensitivity. J Clin Dent 1999; 10:50–54.
Verzijden CW, Creugers NH, Mulder J . A multi-practice clinical study on posterior resin-bonded bridges: a 2.5-year interim report. J Dent Res 1994; 73:529–535.
Izumi H, Oikawa T, Yamaguchi Y, Kobayashi H, Koike T . Clinical experience with indacin compound. Evaluation of the analgesic effect by sequential analysis using the double blind method. J Nihon Univ Sch Dent 1968; 10:95–101.
Brodin P, Miles TS, Türker KS . Simple reaction-time responses to mechanical and electrical stimuli in human masseter muscle. Arch Oral Biol 1993; 38:221–226.
Oringer RJ, Howell TH, Nevins ML, et al. Relationship between crevicular aspartate aminotransferase levels and periodontal disease progression. J Periodontol 2001; 72:17–24.
Chainani-Wu N, Silverman Jr S, Reingold A, et al. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Phytomedicine 2007; 14:437–446.
Molander A, Warfvinge J, Reit C, Kvist T . Clinical and radiographic evaluation of one- and two-visit endodontic treatment of asymptomatic necrotic teeth with apical periodontitis: a randomized clinical trial. J Endod 2007; 33:1145–1148.
Zagdwon AM, Fayle SA, Pollard MA . A prospective clinical trial comparing preformed metal crowns and cast restorations for defective first permanent molars. Eur J Paediatr Dent 2003; 4:138–142.
Clauser C, Barone R . Effect of incision and flap reflection on postoperative pain after the removal of partially impacted mandibular third molars. Quintessence Int 1994; 25:845–849.
MacGregor AJ, Hutchinson D . The effect of sulfonamides on pain and swelling following removal of ectopic third molars. Int J Oral Surg 1975; 4:184–190.
Cheng KK, Chang AM, Yuen MP . Prevention of oral mucositis in paediatric patients treated with chemotherapy: a randomised crossover trial comparing two protocols of oral care. Eur J Cancer 2004; 40:1208–1216.
Stephens AJ, Sapsford DJ, Curzon ME . Intravenous sedation for handicapped dental patients: a clinical trial of midazolam and propofol. Br Dent J 1993; 175:20–25.
Bravo M, Montero J, Bravo JJ, Baca P, Llodra JC . Sealant and fluoride varnish in caries: a randomized trial. J Dent Res 2005; 84:1138–1143.
Clerehugh V, Williams P, Shaw WC, Worthington HV, Warren P . A practice-based randomised controlled trial of the efficacy of an electric and a manual toothbrush on gingival health in patients with fixed orthodontic appliances. J Dent 1988; 26:633–639.
Pocock SJ . Interim analyses for randomized clinical trials: the group sequential approach. Biometrics 1982; 38:153–162.
Aickin M . Randomization, balance, and the validity and efficiency of design-adaptive allocation methods. J Stat Plan Inference 2001; 94:97–119.
Maloney A, Karlsson MO, Simonsson USH . Optimal adaptive design in clinical drug development: a simulation example. J Clin Pharmacol 2007; 47:1231–1243.
Viera AJ, Bangdiwala SI . Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 2007; 39:132–137.
Colditz GA, Miller JN, Mosteller F . How study design affects outcomes in comparisons of therapy. I. Medical. Stat Med 1989; 8:441–454.
Dragalin V . Adaptive designs: terminology and classification. Drug Inf J 2006; 40:425–435.
Bauer P, Brannath W . The advantages and disadvantages of adaptive designs for clinical trials. Drug Discov Today 2004; 9:351–357.
Author information
Authors and Affiliations
Corresponding author
Additional information
Conflicts of interest
The authors declare that they have no conflicts of interest.
Rights and permissions
About this article
Cite this article
Bogowicz, P., Flores-Mir, C., Major, P. et al. Sequential analysis applied to clinical trials in dentistry: a systematic review. Evid Based Dent 9, 55–60 (2008). https://doi.org/10.1038/sj.ebd.6400587
Published:
Issue date:
DOI: https://doi.org/10.1038/sj.ebd.6400587
