- Email: [email protected]
Standard Operating Procedures Approach for the Implementation of the Evidence-based Dentistry Concept in Dental Practice
FEATURE ARTICLE
Standard Operating Procedures Approach for the Implementation of the Evidence-based Dentistry Concept in Dental Practice Clóvis M. Faggion Jr, DDS, Drmed.dent*, Yu-Kang Tu, DDS, MSc, PhD† *From Private Practice, Florianópolis Brazil. †Senior Clinical Research Fellow, Department of Periodontology, Leeds Dental Institute, and Biostatistics Unit, Centre for Epidemiology and Biostatistics, University of Leeds, Leeds, UK
Evidence-based dentistry is a concept that when applied to clinical practice may improve the quality of dental treatment. However, dentists’ reluctance to change their behavior may be a barrier to the implementation of the process. The main purpose of this study was to demonstrate that standard operating procedures (SOPs) may help dentists to apply scientific evidence to their dental practice. SOPs are written instructions on how to execute some specific tasks. A flowchart model demonstrated how an ordinary clinical procedure (composite restoration) can be performed using evidence-based information to support each executed step. Implementing the model into daily practice is straightforward, and the results are accessible to the whole dental team. In addition, the flowchart can be regularly updated with highquality dental literature such as systematic reviews of randomized controlled trials and randomized controlled trials. This proposed model may help to bridge the gap between research and clinical dental practice by serving as a practical tool to improve the knowledge of dental practitioners and the quality of treatment.
INTRODUCTION The evidence-based dentistry concept (EBD) uses published guidelines as important tools for its implementation. It is expected that by following these guidelines, correct decisions and treatments of high quality can be more frequently achieved. However, there is some evidence showing that this approach may not be efficient enough to improve the There was no external source of funding for the study and the authors have no conflict of interest of any sort related to the results of this study.
J Evid Base Dent Pract 2007;7:102-107 1532-3382/$35.00 © 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2007.06.004
general dental practitioner’s clinical decision-making skills.1,2 Some professionals are afraid that guidelines might reduce their autonomy in clinical treatments, despite the fact that this approach may help them in decision making.1 In addition, the format in which the guidelines are introduced to dental surgeons might be another obstacle to the implementation of the EBD concept. Usually, guidelines are presented in long and complex texts3 that may prohibit their use by professionals. Furthermore, there are relative to the number of procedures performed by dentists, only a few guidelines on dental treatment procedures available, and this limits their use in implementing the concept of EBD into clinical practice. Thus, standard operating procedures (SOPs) are written instructions with the objective of consistently provid-
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
chart. This may help dentists to incorporate the evidencebased dentistry philosophy into their daily routine practices.
TABLE 1. Inclusion and exclusion criteria of studies Inclusion criteria: Systematic reviews of randomized controlled trials (SR) and randomized controlled trials (RCT) Studies directly related to the PICO question Clinical studies Exclusion criteria: Study designs other than SR and RCT Studies with objectives not related to the PICO question Nonclinical studies
ing up-to-date treatment when a specific procedure is performed repeatedly. In the health sciences this concept has already been applied to other fields such as nursing and medicine.4-6 However, in clinical dentistry, there are few publications on this methodology, and standardized procedures are presented without incorporating the evidence-based concept.7 The objective of this report was to demonstrate how an integrated model of the SOPs approach that is based on available research evidence can be organized into a flow-
STANDARD OPERATING PROCEDURES AND EVIDENCE-BASED DENTISTRY MODEL (EBD/SOPS) The scenario is a general dental practice where routine dental procedures are performed. The demonstrated procedure is the direct composite restoration. On January 2, 2007, systematic reviews of randomized clinical trials (SR) related to treatment with direct composite restorations were retrieved from the PubMed electronic database, selected and used as a reference for construction of the flowchart. When systematic reviews were not available, randomized clinical trials (RCT) were used. Exclusion/inclusion criteria for the selection of studies are described in Table 1. A common dental treatment procedure (composite filling) exemplified the model, and each box in the chart presented 1 step in the dental treatment procedure and the level of evidence (Figure 1). If there was no available evidence for a step in the treatment procedure, the designation NCE (no clinical evidence) was inserted in the box. Where there was only inconclusive evidence, the box
(1) Explanation of the procedure to the patient:
(4) Dental etching: S: Use of 3-step etch
NCE
Level of Evidence: 1a
(2) Rubber dam use: S: Use of cotton roll isolation
(5) Composite insertion: S: Use of incremental technique
Level of Evidence: 1b
NCE
(3) Cavity preparation: S: Use of rotation bur
(6) Occlusion check: S: Remove interferences
NCE
ICE
Materials - Clinical and composite instruments - Anesthetics - Cotton roll - Carpule syringe - Color scale - Cavity preparation burs - Adhesive system - Brush - Composite - Finishing and polishing burs - Occlusal contact paper - Final polishing gummy tips
Legend: S: suggestion NCE: No Clinical Evidence ICE: Inconclusive Evidence
Figure 1. Dental procedure (composite filling tooth 36 [class I]). Volume 7, Number 3
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TABLE 2. PICO questions and key words related to the different steps of the dental procedure Topics Rubber dam
Cavity preparation
Dental etching/bonding
Composite insertion
Occlusion check
PICO question How does using rubber dam improve the long-term survival of posterior dental filling compared to partial isolation (cotton rolls)? Which technique is better for the long-term survival of a dental composite: rotation bur or laser? Which dental etching/ bonding technique shows better clinical performance: the etchand-rinse adhesive or the self-etch system? Which is the best strategy regarding composite insertion to avoid the polymerization shrinkage stress? Can lack of occlusal adjustment after a restorative procedure cause temporomandibular disorders (TMD)?
was completed with ICE (inconclusive evidence). In addition, the right side of the flowchart gave the suggested materials for the execution of the procedure. The decision to use only SR and RCT for the construction of the EBD/SOPs model followed a proposed hierarchy of evidence8 in which these study designs are suggested as the highest level of evidence for therapeutic treatments. The search was performed within the PubMed Clinical Queries section, a specialized search tool for clinicians. A well-structured and specific question in the PICO (Patient, Intervention, Comparison, Outcome) format,9 related to some important aspect of the procedure, was created in order to focus the literature search. Key words were defined using the PICO question as a reference to retrieve high-quality literature efficiently (Table 2).10-14
RESULTS (1) Rubber dam use: No systematic review was found. In the “clinical study category mode,” 15 articles were retrieved and one RCT10 directly related to the PICO question was selected. In this study, restorations were 104
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Key Words
Article Search Results
Rubber AND dam AND comparison
Raskin et al 200010
Laser AND bur*
No studies
Self-etch*
Peumans et al 200511
Composite Composite Composite Composite
AND AND AND AND
dent* insertion increment* microleakage
Occlus* AND dent*
Wilson et al 200012
Michelotti et al 200513 Le Bell et al 200214
placed with cotton rolls and aspiration (n ⫽ 52) or with the rubber dam (n ⫽ 48) as isolation techniques for the cavity preparation. After 10 years, 37 restorations were evaluated against a modified rating system (USPHS). The results showed no difference in clinical performance for composites placed using both techniques. (2) Cavity preparation: One article was retrieved in the “find systematic reviews mode” but it was excluded by abstract analysis (not a systematic review). In the “clinical study category mode,” 16 articles were retrieved but all were excluded by abstract analysis (all studies were not clinical). Therefore, this topic received the NCE mark. (3) Dental etching/bonding: Three articles were retrieved in the “find systematic reviews mode” and one SR compared the clinical effectiveness of both systems.11 The authors concluded that 3-step etch and rinse adhesives and 2-step self-etch adhesives showed good clinical performance. (4) Composite insertion: The search retrieved 80 articles in the “find systematic reviews mode” with no systematic reviews directly related to the PICO question. September 2007
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
In the “clinical study category mode” 21 articles were found with key words composite AND insertion. No clinical study directly related to the PICO question was retrieved. In the same search mode, when the key-words composite AND increment* were used, 78 articles were found. Most of these were excluded by title and abstract analysis and the main reason for exclusion was the type of study (nonclinical studies). One clinical trial12 tested an incremental technique in 40 Class II molars and demonstrated good clinical results. However, there was no randomization and control group for comparison. When composite AND microleakage key words were used in the “clinical study category mode.” 113 articles were found. Again, no clinical study comparing both techniques was retrieved. Most articles were “in vitro” studies and therefore were excluded on title and abstract analysis. As a result, this topic received the NCE mark. (5) Occlusion check: There were 131 articles found in the “find systematic reviews mode,” but no SR directly related to the topic was selected. In the “clinical study category mode,” 390 articles were retrieved and again no RCT directly related to the PICO question was found. However, 1 RCT13 assessed artificial occlusal interferences that were left in place for 8 days in 11 healthy females. The authors reported that none of the subjects developed signs or symptoms of temporomandibular disorder (TMD) during the observation period. Another RCT,14 however, demonstrated that artificial interferences caused an increase in clinical signs in 21 patients with a history of TMD. Therefore, the evidence is inconclusive (ICE). The flowchart describing the procedure, the assessed evidence and the suggested materials is shown in Figure 1.
DISCUSSION The main objective of this developing approach was to demonstrate how to integrate the best available clinical evidence into dental procedures that are routinely conducted within dental practice. It is important to note that after the clinical diagnosis and treatment plan have been made, our proposed model can provide evidence-based guidance for each step of the planned treatment procedure. This might help the busy dental practitioner to change their practices from an empirical to a solid, scientific basis. So far there are only a limited number of published dental guidelines on a few clinical issues and to update the information in those guidelines demands effort from the people or groups who created them.3,15,16 The proposed model incorporates evidence from SR and RCT by dental practitioners, who are responsible for the regular update of the scientific evidence in the flowchart model Volume 7, Number 3
through the addition of new evidence as soon as new studies are published in various electronic databases. In this way, dentists become more active in the whole EBD process,17 searching for current literature themselves and not depending on others to update it. In clinical practice, the SOPs format may improve the communication between dental practitioners and dental staff (mainly dental assistants) who can promptly organize the materials for the scheduled dental procedures. The SOPs flowchart format allows a straightforward visualization of the various steps of the dental procedure and the instruments/equipment required to perform the treatment. It can also be printed and organized by the dental team and form the basis, for example, of a manual of clinical procedures. All these features may contribute to a reduction in the operating time and a subsequent increase in the efficiency of the dental practice. In relation to educational issues, this model may improve the way in which continuing dental education courses are taught to dental professionals. In these courses, dental practitioners learn how to plan and execute clinical procedures under the supervision of lecturers and clinical instructors. However, in many situations, the instructors tend to defend their points of view and this may generate biased treatments. When dental practitioners assume a self-learning process, they can develop critical-thinking skills and become more competent at filtering relevant from nonrelevant clinical information. In this way, they can scrutinize the lecturer’s/clinical instructor’s arguments using sound scientific arguments for discussion. The results of the literature search demonstrated a lack of clinical evidence on the assessed steps of the dental procedure (no clinical and quality data were retrieved for the “cavity preparation” and “composite insertion” topics). In fact, the lack of SR and RCT studies was the most common reason for the exclusion of the various studies assessed. One topic (occlusion check) had weak evidence and therefore was considered inconclusive. This suggests that some of the steps in well-established dental procedures might be performed today without solid scientific support. More rigorous studies such as RCT are required to adequately address these questions. Note that the literature search in this study was not intended to be as comprehensive as a systematic review, because it would not be realistic for busy dental practitioners to conduct a systematic review for every single clinical procedure they practice daily. Nevertheless, the approach of using some specific key words within the PICO frame may focus the search and retrieve high-quality literature. The database used in the searching process was PubMed. Other databases can also be used in conjunction with PubMed to broaden the literature search. In fact, PubMed is a practical choice because it contains the Faggion and Tu
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vast majority of dental literature and is free of charge for its users. Therefore, PubMed is probably the database most likely being used by general dentists who have no access to academic resources. The critical assessment of selected dental literature is necessary for the good functioning of the model. The use of checklists such as Quality of Reporting of Meta-analyses (QUOROM)18 and Consolidated Standards of Reporting Trials (CONSORT)19 helps dental practitioners to assess the quality of the SR and RCT, respectively. Some tools have been developed to facilitate checklist use by clinicians.20 From the 5 selected studies, 1 is a randomized clinical trial10 that used dental students as patients. In this study, some methodological aspects such as allocation concealment and randomization are not described in detail. Therefore, the results should be interpreted with caution. One systematic review of clinical trials11 involved the assessment of full-text articles together with selected abstracts, and for this reason the results should also be viewed with caution. The study on the composite resin insertion12 was not a randomized controlled trial, and new studies with an improved, rigorous design are required in order to provide definitive results. Two studies were found to test whether or not artificial interferences may cause TMD in patients with and without history of TMD, respectively.13,14 The first study only included health participants without any history of TMD and adopted a crossover study design, ie, each participant served as his or her own control. The second study included both patients with or without a history of TMD. However, neither of these 2 studies reported sample size calculation, while the second one14 had a larger sample size. Although both studies claimed to be double-blinded, it is not clear that for an intervention such as adding restorative material on the tooth surfaces, patients could be kept unaware of which groups they were in. These potential caveats in the study designs should be taken into account for decision making based on the evidence shown in these studies. It is important to comment that the level of evidence described in Figure 1 may not represent the real level after a careful assessment of the included studies. A limitation of this model is that its implementation demands a reasonable amount of time and effort from dental practitioners. However, as previously discussed, this model can also be seen as an opportunity for practitioners to update their knowledge about a specific clinical decision or dental procedure that they have been practicing without a judicious analysis of its relevance. This study proposes and demonstrates a practical approach to incorporate evidence-based dentistry into clinical practice. It can and needs to be tested and validated in a group of general dentists to see to what extent and in which aspect the proposed model can help them with 106
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decision making in the daily practice. Then this model can be further modified and tested again. In conclusion, the presented model shows how to integrate scientific evidence from high-quality studies directly to each step of the dental procedure. Additionally, this approach may also aid dental practitioners in developing critical-thinking skills.
REFERENCES 1. van der Sanden WJ, Mettes DG, Plasschaert AJ, van’t Hof MA, Grol RP, Verdonschot EH. Clinical practice guidelines in dentistry: opinions of dental practitioners on their contribution to the quality of dental care. Qual Saf Health Care 2003;12(2):107-11. 2. van der Sanden WJ, Mettes DG, Plasschaert AJ, Grol RP, Mulder J, Verdonschot EH. Effectiveness of clinical practice guideline implementation on lower third molar management in improving clinical decision-making: a randomized controlled trial. Eur J Oral Sci 2005;113(5):349-54. 3. The Royal College of Surgeons of England. Faculty’s Clinical Effectiveness Committee. Clinical Guidelines [updated May. 2006; cited Jan. 08 2007]. Available at: http://www.rcseng.ac.uk/fds/ clinical_guidelines. Accessed 4. Pape TM, Guerra DM, Muzquiz M, et al. Innovative approaches to reducing nurses’ distractions during medication administration. J Contin Educ Nurs 2005;36(3):108-16; quiz 141-2. 5. Rock G, Neurath D, Laurin M, et al. Development of a total quality system for transfusion medicine services in Ontario hospitals. Transfus Apher Sci 2005;33(3):333-42. Epub 2005 Oct 18. 6. Rohrig R, Meister M, Michel-Backofen A, et al. Online guideline assist in intensive care medicine—is the login-authentication a sufficient trigger for reminders? Stud Health Technol Inform 2006; 124:561-8. 7. Freeman M. Maintaining clinical excellence using SOPs. J Calif Dent Assoc 2004;32(3):253-6. 8. Centre for Evidence-Based Medicine. Oxford Centre for Evidence Based Medicine. Levels of evidence and grades of recommendation [updated May 2001; cited Jan. 9, 2007]. Available at: http:// www.cebm.net/levels_of_evidence.asp. Accessed 9. Akobeng AK. Evidence in practice. Arch Dis Child. 2005;90(8):84952. 10. Raskin A, Setcos JC, Vreven J, Wilson NH. Influence of the isolation method on the 10-year clinical behaviour of posterior resin composite restorations. Clin Oral Investig 2000;4(3):148-52. 11. Peumans M, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Clinical effectiveness of contemporary adhesives: a systematic review of current clinical trials. Dent Mater. 2005;21(9):864-81. 12. Wilson NH, Cowan AJ, Unterbrink G, Wilson MA, Crisp RJ. A clinical evaluation of Class II composites placed using a decoupling technique. J Adhes Dent 2000;2(4):319-29. 13. Michelotti A, Farella M, Gallo LM, Veltri A, Palla S, Martina R. Effect of occlusal interference on habitual activity of human masseter. J Dent Res 2005;84(7):644-8. 14. Le Bell Y, Jamsa T, Korri S, Niemi PM, Alanen P. Effect of artificial occlusal interferences depends on previous experience of temporomandibular disorders. Acta Odontol Scand 2002;60(4):219-22. 15. World Dental Federation. National and International Guidelines, Statements, Position papers, Proceedings and Meta-analyses [cited Jan. 8, 2007]. Available at: http://www. fdiworldental.org/resources/2_0guidelines.html. Accessed 16. National Guideline Clearinghouse [cited Mar. 8, 2007]. Available at: http://www.guideline.gov/. Accessed
September 2007
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE 17. Pitts N. Challenges to evidence based practice. In: Clarkson J, Harrison JE, Ismail AI, Needleman I, Worthington H, editors. Evidence based dentistry for effective practice. London: Martin Dunitz; 2003. p. 179–97. 18. Turpin DL. CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews. Am J Orthod Dentofacial Orthop 2005;128(6):681-5; discussion 686.
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19. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285(15):1987-91. 20. Faggion CM Jr, Tu YK. Evidence based dentistry: a model for clinical practice. J Dent Educ 2007;71:825-31.
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Standard Operating Procedures Approach for the Implementation of the Evidence-based Dentistry Concept in Dental Practice Clóvis M. Faggion Jr, DDS, Drmed.dent*, Yu-Kang Tu, DDS, MSc, PhD† *From Private Practice, Florianópolis Brazil. †Senior Clinical Research Fellow, Department of Periodontology, Leeds Dental Institute, and Biostatistics Unit, Centre for Epidemiology and Biostatistics, University of Leeds, Leeds, UK
Evidence-based dentistry is a concept that when applied to clinical practice may improve the quality of dental treatment. However, dentists’ reluctance to change their behavior may be a barrier to the implementation of the process. The main purpose of this study was to demonstrate that standard operating procedures (SOPs) may help dentists to apply scientific evidence to their dental practice. SOPs are written instructions on how to execute some specific tasks. A flowchart model demonstrated how an ordinary clinical procedure (composite restoration) can be performed using evidence-based information to support each executed step. Implementing the model into daily practice is straightforward, and the results are accessible to the whole dental team. In addition, the flowchart can be regularly updated with highquality dental literature such as systematic reviews of randomized controlled trials and randomized controlled trials. This proposed model may help to bridge the gap between research and clinical dental practice by serving as a practical tool to improve the knowledge of dental practitioners and the quality of treatment.
INTRODUCTION The evidence-based dentistry concept (EBD) uses published guidelines as important tools for its implementation. It is expected that by following these guidelines, correct decisions and treatments of high quality can be more frequently achieved. However, there is some evidence showing that this approach may not be efficient enough to improve the There was no external source of funding for the study and the authors have no conflict of interest of any sort related to the results of this study.
J Evid Base Dent Pract 2007;7:102-107 1532-3382/$35.00 © 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2007.06.004
general dental practitioner’s clinical decision-making skills.1,2 Some professionals are afraid that guidelines might reduce their autonomy in clinical treatments, despite the fact that this approach may help them in decision making.1 In addition, the format in which the guidelines are introduced to dental surgeons might be another obstacle to the implementation of the EBD concept. Usually, guidelines are presented in long and complex texts3 that may prohibit their use by professionals. Furthermore, there are relative to the number of procedures performed by dentists, only a few guidelines on dental treatment procedures available, and this limits their use in implementing the concept of EBD into clinical practice. Thus, standard operating procedures (SOPs) are written instructions with the objective of consistently provid-
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
chart. This may help dentists to incorporate the evidencebased dentistry philosophy into their daily routine practices.
TABLE 1. Inclusion and exclusion criteria of studies Inclusion criteria: Systematic reviews of randomized controlled trials (SR) and randomized controlled trials (RCT) Studies directly related to the PICO question Clinical studies Exclusion criteria: Study designs other than SR and RCT Studies with objectives not related to the PICO question Nonclinical studies
ing up-to-date treatment when a specific procedure is performed repeatedly. In the health sciences this concept has already been applied to other fields such as nursing and medicine.4-6 However, in clinical dentistry, there are few publications on this methodology, and standardized procedures are presented without incorporating the evidence-based concept.7 The objective of this report was to demonstrate how an integrated model of the SOPs approach that is based on available research evidence can be organized into a flow-
STANDARD OPERATING PROCEDURES AND EVIDENCE-BASED DENTISTRY MODEL (EBD/SOPS) The scenario is a general dental practice where routine dental procedures are performed. The demonstrated procedure is the direct composite restoration. On January 2, 2007, systematic reviews of randomized clinical trials (SR) related to treatment with direct composite restorations were retrieved from the PubMed electronic database, selected and used as a reference for construction of the flowchart. When systematic reviews were not available, randomized clinical trials (RCT) were used. Exclusion/inclusion criteria for the selection of studies are described in Table 1. A common dental treatment procedure (composite filling) exemplified the model, and each box in the chart presented 1 step in the dental treatment procedure and the level of evidence (Figure 1). If there was no available evidence for a step in the treatment procedure, the designation NCE (no clinical evidence) was inserted in the box. Where there was only inconclusive evidence, the box
(1) Explanation of the procedure to the patient:
(4) Dental etching: S: Use of 3-step etch
NCE
Level of Evidence: 1a
(2) Rubber dam use: S: Use of cotton roll isolation
(5) Composite insertion: S: Use of incremental technique
Level of Evidence: 1b
NCE
(3) Cavity preparation: S: Use of rotation bur
(6) Occlusion check: S: Remove interferences
NCE
ICE
Materials - Clinical and composite instruments - Anesthetics - Cotton roll - Carpule syringe - Color scale - Cavity preparation burs - Adhesive system - Brush - Composite - Finishing and polishing burs - Occlusal contact paper - Final polishing gummy tips
Legend: S: suggestion NCE: No Clinical Evidence ICE: Inconclusive Evidence
Figure 1. Dental procedure (composite filling tooth 36 [class I]). Volume 7, Number 3
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TABLE 2. PICO questions and key words related to the different steps of the dental procedure Topics Rubber dam
Cavity preparation
Dental etching/bonding
Composite insertion
Occlusion check
PICO question How does using rubber dam improve the long-term survival of posterior dental filling compared to partial isolation (cotton rolls)? Which technique is better for the long-term survival of a dental composite: rotation bur or laser? Which dental etching/ bonding technique shows better clinical performance: the etchand-rinse adhesive or the self-etch system? Which is the best strategy regarding composite insertion to avoid the polymerization shrinkage stress? Can lack of occlusal adjustment after a restorative procedure cause temporomandibular disorders (TMD)?
was completed with ICE (inconclusive evidence). In addition, the right side of the flowchart gave the suggested materials for the execution of the procedure. The decision to use only SR and RCT for the construction of the EBD/SOPs model followed a proposed hierarchy of evidence8 in which these study designs are suggested as the highest level of evidence for therapeutic treatments. The search was performed within the PubMed Clinical Queries section, a specialized search tool for clinicians. A well-structured and specific question in the PICO (Patient, Intervention, Comparison, Outcome) format,9 related to some important aspect of the procedure, was created in order to focus the literature search. Key words were defined using the PICO question as a reference to retrieve high-quality literature efficiently (Table 2).10-14
RESULTS (1) Rubber dam use: No systematic review was found. In the “clinical study category mode,” 15 articles were retrieved and one RCT10 directly related to the PICO question was selected. In this study, restorations were 104
Faggion and Tu
Key Words
Article Search Results
Rubber AND dam AND comparison
Raskin et al 200010
Laser AND bur*
No studies
Self-etch*
Peumans et al 200511
Composite Composite Composite Composite
AND AND AND AND
dent* insertion increment* microleakage
Occlus* AND dent*
Wilson et al 200012
Michelotti et al 200513 Le Bell et al 200214
placed with cotton rolls and aspiration (n ⫽ 52) or with the rubber dam (n ⫽ 48) as isolation techniques for the cavity preparation. After 10 years, 37 restorations were evaluated against a modified rating system (USPHS). The results showed no difference in clinical performance for composites placed using both techniques. (2) Cavity preparation: One article was retrieved in the “find systematic reviews mode” but it was excluded by abstract analysis (not a systematic review). In the “clinical study category mode,” 16 articles were retrieved but all were excluded by abstract analysis (all studies were not clinical). Therefore, this topic received the NCE mark. (3) Dental etching/bonding: Three articles were retrieved in the “find systematic reviews mode” and one SR compared the clinical effectiveness of both systems.11 The authors concluded that 3-step etch and rinse adhesives and 2-step self-etch adhesives showed good clinical performance. (4) Composite insertion: The search retrieved 80 articles in the “find systematic reviews mode” with no systematic reviews directly related to the PICO question. September 2007
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
In the “clinical study category mode” 21 articles were found with key words composite AND insertion. No clinical study directly related to the PICO question was retrieved. In the same search mode, when the key-words composite AND increment* were used, 78 articles were found. Most of these were excluded by title and abstract analysis and the main reason for exclusion was the type of study (nonclinical studies). One clinical trial12 tested an incremental technique in 40 Class II molars and demonstrated good clinical results. However, there was no randomization and control group for comparison. When composite AND microleakage key words were used in the “clinical study category mode.” 113 articles were found. Again, no clinical study comparing both techniques was retrieved. Most articles were “in vitro” studies and therefore were excluded on title and abstract analysis. As a result, this topic received the NCE mark. (5) Occlusion check: There were 131 articles found in the “find systematic reviews mode,” but no SR directly related to the topic was selected. In the “clinical study category mode,” 390 articles were retrieved and again no RCT directly related to the PICO question was found. However, 1 RCT13 assessed artificial occlusal interferences that were left in place for 8 days in 11 healthy females. The authors reported that none of the subjects developed signs or symptoms of temporomandibular disorder (TMD) during the observation period. Another RCT,14 however, demonstrated that artificial interferences caused an increase in clinical signs in 21 patients with a history of TMD. Therefore, the evidence is inconclusive (ICE). The flowchart describing the procedure, the assessed evidence and the suggested materials is shown in Figure 1.
DISCUSSION The main objective of this developing approach was to demonstrate how to integrate the best available clinical evidence into dental procedures that are routinely conducted within dental practice. It is important to note that after the clinical diagnosis and treatment plan have been made, our proposed model can provide evidence-based guidance for each step of the planned treatment procedure. This might help the busy dental practitioner to change their practices from an empirical to a solid, scientific basis. So far there are only a limited number of published dental guidelines on a few clinical issues and to update the information in those guidelines demands effort from the people or groups who created them.3,15,16 The proposed model incorporates evidence from SR and RCT by dental practitioners, who are responsible for the regular update of the scientific evidence in the flowchart model Volume 7, Number 3
through the addition of new evidence as soon as new studies are published in various electronic databases. In this way, dentists become more active in the whole EBD process,17 searching for current literature themselves and not depending on others to update it. In clinical practice, the SOPs format may improve the communication between dental practitioners and dental staff (mainly dental assistants) who can promptly organize the materials for the scheduled dental procedures. The SOPs flowchart format allows a straightforward visualization of the various steps of the dental procedure and the instruments/equipment required to perform the treatment. It can also be printed and organized by the dental team and form the basis, for example, of a manual of clinical procedures. All these features may contribute to a reduction in the operating time and a subsequent increase in the efficiency of the dental practice. In relation to educational issues, this model may improve the way in which continuing dental education courses are taught to dental professionals. In these courses, dental practitioners learn how to plan and execute clinical procedures under the supervision of lecturers and clinical instructors. However, in many situations, the instructors tend to defend their points of view and this may generate biased treatments. When dental practitioners assume a self-learning process, they can develop critical-thinking skills and become more competent at filtering relevant from nonrelevant clinical information. In this way, they can scrutinize the lecturer’s/clinical instructor’s arguments using sound scientific arguments for discussion. The results of the literature search demonstrated a lack of clinical evidence on the assessed steps of the dental procedure (no clinical and quality data were retrieved for the “cavity preparation” and “composite insertion” topics). In fact, the lack of SR and RCT studies was the most common reason for the exclusion of the various studies assessed. One topic (occlusion check) had weak evidence and therefore was considered inconclusive. This suggests that some of the steps in well-established dental procedures might be performed today without solid scientific support. More rigorous studies such as RCT are required to adequately address these questions. Note that the literature search in this study was not intended to be as comprehensive as a systematic review, because it would not be realistic for busy dental practitioners to conduct a systematic review for every single clinical procedure they practice daily. Nevertheless, the approach of using some specific key words within the PICO frame may focus the search and retrieve high-quality literature. The database used in the searching process was PubMed. Other databases can also be used in conjunction with PubMed to broaden the literature search. In fact, PubMed is a practical choice because it contains the Faggion and Tu
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vast majority of dental literature and is free of charge for its users. Therefore, PubMed is probably the database most likely being used by general dentists who have no access to academic resources. The critical assessment of selected dental literature is necessary for the good functioning of the model. The use of checklists such as Quality of Reporting of Meta-analyses (QUOROM)18 and Consolidated Standards of Reporting Trials (CONSORT)19 helps dental practitioners to assess the quality of the SR and RCT, respectively. Some tools have been developed to facilitate checklist use by clinicians.20 From the 5 selected studies, 1 is a randomized clinical trial10 that used dental students as patients. In this study, some methodological aspects such as allocation concealment and randomization are not described in detail. Therefore, the results should be interpreted with caution. One systematic review of clinical trials11 involved the assessment of full-text articles together with selected abstracts, and for this reason the results should also be viewed with caution. The study on the composite resin insertion12 was not a randomized controlled trial, and new studies with an improved, rigorous design are required in order to provide definitive results. Two studies were found to test whether or not artificial interferences may cause TMD in patients with and without history of TMD, respectively.13,14 The first study only included health participants without any history of TMD and adopted a crossover study design, ie, each participant served as his or her own control. The second study included both patients with or without a history of TMD. However, neither of these 2 studies reported sample size calculation, while the second one14 had a larger sample size. Although both studies claimed to be double-blinded, it is not clear that for an intervention such as adding restorative material on the tooth surfaces, patients could be kept unaware of which groups they were in. These potential caveats in the study designs should be taken into account for decision making based on the evidence shown in these studies. It is important to comment that the level of evidence described in Figure 1 may not represent the real level after a careful assessment of the included studies. A limitation of this model is that its implementation demands a reasonable amount of time and effort from dental practitioners. However, as previously discussed, this model can also be seen as an opportunity for practitioners to update their knowledge about a specific clinical decision or dental procedure that they have been practicing without a judicious analysis of its relevance. This study proposes and demonstrates a practical approach to incorporate evidence-based dentistry into clinical practice. It can and needs to be tested and validated in a group of general dentists to see to what extent and in which aspect the proposed model can help them with 106
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decision making in the daily practice. Then this model can be further modified and tested again. In conclusion, the presented model shows how to integrate scientific evidence from high-quality studies directly to each step of the dental procedure. Additionally, this approach may also aid dental practitioners in developing critical-thinking skills.
REFERENCES 1. van der Sanden WJ, Mettes DG, Plasschaert AJ, van’t Hof MA, Grol RP, Verdonschot EH. Clinical practice guidelines in dentistry: opinions of dental practitioners on their contribution to the quality of dental care. Qual Saf Health Care 2003;12(2):107-11. 2. van der Sanden WJ, Mettes DG, Plasschaert AJ, Grol RP, Mulder J, Verdonschot EH. Effectiveness of clinical practice guideline implementation on lower third molar management in improving clinical decision-making: a randomized controlled trial. Eur J Oral Sci 2005;113(5):349-54. 3. The Royal College of Surgeons of England. Faculty’s Clinical Effectiveness Committee. Clinical Guidelines [updated May. 2006; cited Jan. 08 2007]. Available at: http://www.rcseng.ac.uk/fds/ clinical_guidelines. Accessed 4. Pape TM, Guerra DM, Muzquiz M, et al. Innovative approaches to reducing nurses’ distractions during medication administration. J Contin Educ Nurs 2005;36(3):108-16; quiz 141-2. 5. Rock G, Neurath D, Laurin M, et al. Development of a total quality system for transfusion medicine services in Ontario hospitals. Transfus Apher Sci 2005;33(3):333-42. Epub 2005 Oct 18. 6. Rohrig R, Meister M, Michel-Backofen A, et al. Online guideline assist in intensive care medicine—is the login-authentication a sufficient trigger for reminders? Stud Health Technol Inform 2006; 124:561-8. 7. Freeman M. Maintaining clinical excellence using SOPs. J Calif Dent Assoc 2004;32(3):253-6. 8. Centre for Evidence-Based Medicine. Oxford Centre for Evidence Based Medicine. Levels of evidence and grades of recommendation [updated May 2001; cited Jan. 9, 2007]. Available at: http:// www.cebm.net/levels_of_evidence.asp. Accessed 9. Akobeng AK. Evidence in practice. Arch Dis Child. 2005;90(8):84952. 10. Raskin A, Setcos JC, Vreven J, Wilson NH. Influence of the isolation method on the 10-year clinical behaviour of posterior resin composite restorations. Clin Oral Investig 2000;4(3):148-52. 11. Peumans M, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Clinical effectiveness of contemporary adhesives: a systematic review of current clinical trials. Dent Mater. 2005;21(9):864-81. 12. Wilson NH, Cowan AJ, Unterbrink G, Wilson MA, Crisp RJ. A clinical evaluation of Class II composites placed using a decoupling technique. J Adhes Dent 2000;2(4):319-29. 13. Michelotti A, Farella M, Gallo LM, Veltri A, Palla S, Martina R. Effect of occlusal interference on habitual activity of human masseter. J Dent Res 2005;84(7):644-8. 14. Le Bell Y, Jamsa T, Korri S, Niemi PM, Alanen P. Effect of artificial occlusal interferences depends on previous experience of temporomandibular disorders. Acta Odontol Scand 2002;60(4):219-22. 15. World Dental Federation. National and International Guidelines, Statements, Position papers, Proceedings and Meta-analyses [cited Jan. 8, 2007]. Available at: http://www. fdiworldental.org/resources/2_0guidelines.html. Accessed 16. National Guideline Clearinghouse [cited Mar. 8, 2007]. Available at: http://www.guideline.gov/. Accessed
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JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE 17. Pitts N. Challenges to evidence based practice. In: Clarkson J, Harrison JE, Ismail AI, Needleman I, Worthington H, editors. Evidence based dentistry for effective practice. London: Martin Dunitz; 2003. p. 179–97. 18. Turpin DL. CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews. Am J Orthod Dentofacial Orthop 2005;128(6):681-5; discussion 686.
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19. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285(15):1987-91. 20. Faggion CM Jr, Tu YK. Evidence based dentistry: a model for clinical practice. J Dent Educ 2007;71:825-31.
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