The design and analysis of split-mouth studies: What statisticians and clinicians should know
The split‐mouth design is a popular design in oral health research. In the most common split‐mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter‐individual variability from t...
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| Published in | Statistics in medicine Vol. 28; no. 28; pp. 3470 - 3482 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Chichester, UK
John Wiley & Sons, Ltd
10.12.2009
Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
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| Abstract | The split‐mouth design is a popular design in oral health research. In the most common split‐mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter‐individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split‐mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split‐mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice. Copyright © 2009 John Wiley & Sons, Ltd. |
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| AbstractList | The split‐mouth design is a popular design in oral health research. In the most common split‐mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter‐individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split‐mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split‐mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice. Copyright © 2009 John Wiley & Sons, Ltd. The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split-mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split-mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice. [PUBLICATION ABSTRACT] The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split-mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split-mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice.The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split-mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split-mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice. The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect. However, already about 20 years ago the pitfalls of the design have been reported in the oral health literature. Yet, many clinicians are not aware of the potential problems with the split-mouth design. Further, it is our experience that most statisticians are not even aware of the existence of this design. Since most of the critical remarks appeared in the oral health literature, we argue that it is necessary to introduce the split-mouth design to a statistical audience, so that both clinicians and statisticians clearly understand the advantages, limitations, statistical considerations, and implications of its use in clinical trials and advise them on its use in practice. |
| Author | Worthington, Helen Philstrom, Bruce Needleman, Ian Lesaffre, Emmanuel |
| Author_xml | – sequence: 1 givenname: Emmanuel surname: Lesaffre fullname: Lesaffre, Emmanuel email: e.lesaffre@erasmusmc.nl organization: Department of Biostatistics, Erasmus Medical Center, Rotterdam, Netherlands – sequence: 2 givenname: Bruce surname: Philstrom fullname: Philstrom, Bruce organization: Oral Health Research Consultant, Bethesda, MD, U.S.A – sequence: 3 givenname: Ian surname: Needleman fullname: Needleman, Ian organization: Unit of Periodontology, UCL Eastman Dental Institute, London, U.K – sequence: 4 givenname: Helen surname: Worthington fullname: Worthington, Helen organization: School of Dentistry, The University of Manchester, Manchester, U.K |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/19536744$$D View this record in MEDLINE/PubMed |
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| Copyright | Copyright © 2009 John Wiley & Sons, Ltd. Copyright (c) 2009 John Wiley & Sons, Ltd. Copyright John Wiley and Sons, Limited Dec 10, 2009 |
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| References | Ramfjord S, Nissle R, Shick R, Cooper H. Subgingival curettage versus surgical elimination of periodontal pockets. Journal of Periodontology 1968; 39:167-175. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. British Medical Journal 2003; 327:557-560. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer: New York, 2000. Antczak-Bouckoms A, Tulloch J, Berkey C. Split-mouth and cross-over designs in dental research. Journal of Clinical Periodontology 1990; 17:446-453. Hujoel P, DeRouen T. Validity issues in split-mouth trials. Journal of Clinical Periodontology 1992; 19:625-627. Senn S. Cross-over Trials in Clinical Research. Wiley: New York, 1993. Andersen EB. Conditional Inference and Models for Measuring. Forskningsinstitut: Copenhagen, 1973. Chung K, Salkin L, Stein M, Freedman A. Clinical evaluation of a biodegradable collagen membrane in guided tissue regeneration. Journal of Periodontology 1990; 61(12):732-736. Loos G, Louwerse P, van Winkelhoff A, Burger W, Gilijamse M, Hart A, van der Velden U. Use of barrier membranes and systemic antibiotics in the treatment of intraosseous defects. Journal of Clinical Periodontology 2002; 29:910-921. Mora F, Etienne D, Ouhayoun J. Treatment of interproximal angular defects by GTR: 1 year follow-up. Journal of Oral Rehabilitation 1996; 23:599-606. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002; 21:1539-1558. Cortellini P, Carnevale G, Sanz M, Tonetti M. Treatment of deep and shallow intrabony defects. A multicenter randomized controlled clinical trial. Journal of Clinical Periodontology 1998; 25(12):981-987. Haukali G, Poulsen S. Effect of a varnish containing chlorhexidines and thymol (Cervitec®) on approximal caries in 13- to 16-year-old schoolchildren in a low caries area. Caries Research 2003; 37:185-189. Palm A, Kirkegaard U, Poulsen S. The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset. Pediatric Dentistry 2004; 26(6):481-484. Blumenthal N, Steinberg J. The use of collagen membrane barriers in conjunction with combined demineralized T bone-collagen gel implants in human infrabony defects. Journal of Periodontology 1996; 61(6):319-327. Higgins J, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008]. The Cochrane Collaboration: http://www.cochrane-handbook.org, 2008. Pontoriero R, Wennstrom J, Lindhe J. The use of barrier membranes and enamel matrix proteins in the treatment of angular bone defects. Journal of Clinical Periodontology 1999; 26:833-840. Donner A, Zou G. Methods for the statistical analysis of binary data in split-smouth designs with baseline measurements. Statistics in Medicine 2007; 26:3476-3486. Riordan P, FitzGerald P. Outcome measures in split mouth caries trials and their statistical evaluation. Community Dentistry Oral Epidemiology 1994; 22:192-197. Hujoel P, Moulton L. Evaluation of test statistics in split-mouth clinical trials. Journal of Periodontology Research 1988; 23:378-380. Lesaffre E, Garcia-Zattera M-J, Redmond C, Needleman I. Reported methodological quality of split-mouth studies. Journal of Clinical Periodontology 2007; 34(9):756-761. Hujoel P. Design and analysis issues in split mouth clinical trials. Community Dentistry Oral Epidemiology 1998; 26:85-86. Pritlove-Carson S, Palmer R, Floyd P. Evaluation of GTR in the treatment of paired periodontal defects. British Dental Journal 1995; 179:388-394. Molenberghs G, Verbeke G. Models for Discrete Longitudinal Data. Springer: Berlin, 2006. Follman D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. Clinical Epidemiology 1992; 45(7):769-773. Ratka-Kruger P, Neukranz E, Raetzke P. Guided tissue regeneration with bioresorbable membranes versus conventional flap surgery in the treatment of infrabony periodontal defects. Journal of Clinical Periodontology 2000; 27:120-127. Vaeth M, Poulsen S. Comments on a commentary: statistical evaluation of split mouth caries trials. Community Dentistry Oral Epidemiology 1998; 26:80-83. Hujoel P, Loesche W. Efficiency of split-mouth designs. Journal of Clinical Periodontology 1990; 17:722-728. Donner A, Klar N, Zou G. Methods for the statistical analysis of binary data in split-cluster designs. Biometrics 2004; 60:919-925. 1998; 26 2000; 27 2004; 60 1990; 17 2004; 26 1999; 26 2008 1994; 22 1992; 19 2003; 37 2006 1973 2005 1995; 179 1993 2007; 34 1998; 25 1990; 61 2003; 327 2002; 29 1968; 39 2000 2002; 21 1996; 61 1988; 23 1992; 45 2007; 26 1996; 23 Molenberghs G (e_1_2_1_12_2) 2006 e_1_2_1_22_2 e_1_2_1_23_2 e_1_2_1_20_2 e_1_2_1_21_2 e_1_2_1_26_2 e_1_2_1_27_2 e_1_2_1_24_2 Senn S (e_1_2_1_11_2) 1993 e_1_2_1_25_2 e_1_2_1_28_2 e_1_2_1_29_2 Andersen EB (e_1_2_1_16_2) 1973 e_1_2_1_6_2 e_1_2_1_30_2 e_1_2_1_7_2 e_1_2_1_4_2 e_1_2_1_5_2 e_1_2_1_2_2 e_1_2_1_3_2 e_1_2_1_32_2 e_1_2_1_10_2 e_1_2_1_31_2 e_1_2_1_15_2 Verbeke G (e_1_2_1_13_2) 2000 e_1_2_1_14_2 Palm A (e_1_2_1_9_2) 2004; 26 e_1_2_1_19_2 e_1_2_1_8_2 e_1_2_1_17_2 e_1_2_1_18_2 |
| References_xml | – reference: Loos G, Louwerse P, van Winkelhoff A, Burger W, Gilijamse M, Hart A, van der Velden U. Use of barrier membranes and systemic antibiotics in the treatment of intraosseous defects. Journal of Clinical Periodontology 2002; 29:910-921. – reference: Hujoel P. Design and analysis issues in split mouth clinical trials. Community Dentistry Oral Epidemiology 1998; 26:85-86. – reference: Ratka-Kruger P, Neukranz E, Raetzke P. Guided tissue regeneration with bioresorbable membranes versus conventional flap surgery in the treatment of infrabony periodontal defects. Journal of Clinical Periodontology 2000; 27:120-127. – reference: Lesaffre E, Garcia-Zattera M-J, Redmond C, Needleman I. Reported methodological quality of split-mouth studies. Journal of Clinical Periodontology 2007; 34(9):756-761. – reference: Haukali G, Poulsen S. Effect of a varnish containing chlorhexidines and thymol (Cervitec®) on approximal caries in 13- to 16-year-old schoolchildren in a low caries area. Caries Research 2003; 37:185-189. – reference: Chung K, Salkin L, Stein M, Freedman A. Clinical evaluation of a biodegradable collagen membrane in guided tissue regeneration. Journal of Periodontology 1990; 61(12):732-736. – reference: Mora F, Etienne D, Ouhayoun J. Treatment of interproximal angular defects by GTR: 1 year follow-up. Journal of Oral Rehabilitation 1996; 23:599-606. – reference: Pontoriero R, Wennstrom J, Lindhe J. The use of barrier membranes and enamel matrix proteins in the treatment of angular bone defects. Journal of Clinical Periodontology 1999; 26:833-840. – reference: Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002; 21:1539-1558. – reference: Higgins J, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008]. The Cochrane Collaboration: http://www.cochrane-handbook.org, 2008. – reference: Vaeth M, Poulsen S. Comments on a commentary: statistical evaluation of split mouth caries trials. Community Dentistry Oral Epidemiology 1998; 26:80-83. – reference: Molenberghs G, Verbeke G. Models for Discrete Longitudinal Data. Springer: Berlin, 2006. – reference: Blumenthal N, Steinberg J. The use of collagen membrane barriers in conjunction with combined demineralized T bone-collagen gel implants in human infrabony defects. Journal of Periodontology 1996; 61(6):319-327. – reference: Pritlove-Carson S, Palmer R, Floyd P. Evaluation of GTR in the treatment of paired periodontal defects. British Dental Journal 1995; 179:388-394. – reference: Senn S. Cross-over Trials in Clinical Research. Wiley: New York, 1993. – reference: Donner A, Zou G. Methods for the statistical analysis of binary data in split-smouth designs with baseline measurements. Statistics in Medicine 2007; 26:3476-3486. – reference: Follman D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. Clinical Epidemiology 1992; 45(7):769-773. – reference: Riordan P, FitzGerald P. Outcome measures in split mouth caries trials and their statistical evaluation. Community Dentistry Oral Epidemiology 1994; 22:192-197. – reference: Palm A, Kirkegaard U, Poulsen S. The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset. Pediatric Dentistry 2004; 26(6):481-484. – reference: Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. British Medical Journal 2003; 327:557-560. – reference: Ramfjord S, Nissle R, Shick R, Cooper H. Subgingival curettage versus surgical elimination of periodontal pockets. Journal of Periodontology 1968; 39:167-175. – reference: Hujoel P, Loesche W. Efficiency of split-mouth designs. Journal of Clinical Periodontology 1990; 17:722-728. – reference: Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer: New York, 2000. – reference: Cortellini P, Carnevale G, Sanz M, Tonetti M. Treatment of deep and shallow intrabony defects. A multicenter randomized controlled clinical trial. Journal of Clinical Periodontology 1998; 25(12):981-987. – reference: Hujoel P, DeRouen T. Validity issues in split-mouth trials. Journal of Clinical Periodontology 1992; 19:625-627. – reference: Andersen EB. Conditional Inference and Models for Measuring. Forskningsinstitut: Copenhagen, 1973. – reference: Hujoel P, Moulton L. Evaluation of test statistics in split-mouth clinical trials. Journal of Periodontology Research 1988; 23:378-380. – reference: Antczak-Bouckoms A, Tulloch J, Berkey C. Split-mouth and cross-over designs in dental research. Journal of Clinical Periodontology 1990; 17:446-453. – reference: Donner A, Klar N, Zou G. Methods for the statistical analysis of binary data in split-cluster designs. 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A multicenter randomized controlled clinical trial publication-title: Journal of Clinical Periodontology – ident: e_1_2_1_14_2 doi: 10.1111/j.0006-341X.2004.00247.x – ident: e_1_2_1_27_2 doi: 10.1038/sj.bdj.4808933 – volume-title: Linear Mixed Models for Longitudinal Data year: 2000 ident: e_1_2_1_13_2 – ident: e_1_2_1_4_2 doi: 10.1111/j.1600-0528.1998.tb01932.x – ident: e_1_2_1_24_2 doi: 10.1902/jop.1990.61.6.319 – ident: e_1_2_1_10_2 doi: 10.1159/000070442 – ident: e_1_2_1_31_2 doi: 10.1111/j.1600-0528.1994.tb01839.x – ident: e_1_2_1_23_2 doi: 10.1111/j.1365-2842.1996.tb00898.x – ident: e_1_2_1_18_2 doi: 10.1002/14651858.CD003875.pub2 – ident: e_1_2_1_2_2 doi: 10.1111/j.1600-051X.1990.tb01060.x – ident: e_1_2_1_25_2 doi: 10.1034/j.1600-051X.2002.291006.x – ident: e_1_2_1_3_2 doi: 10.1111/j.1600-051X.1992.tb01709.x – volume-title: Cross‐over Trials in Clinical Research year: 1993 ident: e_1_2_1_11_2 – ident: e_1_2_1_28_2 doi: 10.1034/j.1600-051x.2000.027002120.x – ident: e_1_2_1_15_2 doi: 10.1002/sim.2782 – volume: 26 start-page: 481 issue: 6 year: 2004 ident: e_1_2_1_9_2 article-title: The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset publication-title: Pediatric Dentistry – ident: e_1_2_1_7_2 doi: 10.1111/j.1600-0765.1988.tb01616.x – ident: e_1_2_1_20_2 doi: 10.1002/9780470712184 – ident: e_1_2_1_32_2 doi: 10.1111/j.1600-0528.1998.tb01930.x – ident: e_1_2_1_26_2 doi: 10.1034/j.1600-051X.1997.00833.x – ident: e_1_2_1_22_2 doi: 10.1902/jop.1990.61.12.732 – ident: e_1_2_1_21_2 doi: 10.1111/j.1600-051X.1998.tb02402.x – ident: e_1_2_1_29_2 doi: 10.1002/sim.1186 – volume-title: Conditional Inference and Models for Measuring year: 1973 ident: e_1_2_1_16_2 – ident: e_1_2_1_8_2 doi: 10.1111/j.1600-051X.1990.tb02343.x – volume-title: Models for Discrete Longitudinal Data year: 2006 ident: e_1_2_1_12_2 – ident: e_1_2_1_30_2 doi: 10.1136/bmj.327.7414.557 – ident: e_1_2_1_5_2 doi: 10.1111/j.1600-051X.2007.01118.x – ident: e_1_2_1_19_2 doi: 10.1016/0895-4356(92)90054-Q – ident: e_1_2_1_17_2 doi: 10.1002/14651858.CD001724.pub2 – ident: e_1_2_1_6_2 doi: 10.1902/jop.1968.39.3.167 |
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| Snippet | The split‐mouth design is a popular design in oral health research. In the most common split‐mouth study, each of two treatments are randomly assigned to... The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to... |
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| SubjectTerms | Adolescent Analysis Anesthesia - methods Child Chlorhexidine - pharmacology Data Interpretation, Statistical Dental Care - methods Dental Caries - prevention & control dental clinical trials Design Drug Combinations Estimates Female Humans intra-subject comparisons Male Medical research Medical statistics oral health research Pain - prevention & control Randomized Controlled Trials as Topic Research Design split-mouth design Thymol - pharmacology |
| Title | The design and analysis of split-mouth studies: What statisticians and clinicians should know |
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