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The Efficacy of Fluoride on Root Caries Progression May Be Dose-dependent
DIAGNOSIS/TREATMENT/PROGNOSIS
ARTICLE ANALYSIS & EVALUATION ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION A randomized clinical trial of the anti-caries efficacy of 5000 compared to 1450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. Caries Res 2013;47(5):391-98.
REVIEWER Andr e V. Ritter, DDS, MS, MBA
PURPOSE/QUESTION Is 5000 ppm fluoridated toothpaste used twice daily more efficacious than 1450 ppm fluoridated toothpaste used twice daily for controlling root caries progression in elderly disabled nursing home residents?
SOURCE OF FUNDING This study was supported by a donation from Colgate Palmolive, manufacturer of the two toothpaste interventions
TYPE OF STUDY/DESIGN This was a randomized clinical trial done with a convenience sample, with elements of comparative effectiveness design
LEVEL OF EVIDENCE Level 2: Limited-quality, patient-oriented evidence
STRENGTH OF RECOMMENDATION GRADE Not applicable J Evid Base Dent Pract 2013;13:177-179 1532-3382/$36.00 Ó 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jebdp.2013.10.014
The Efficacy of Fluoride on Root Caries Progression May Be Dose-dependent SUMMARY Subjects One hundred eighty-three residents of six Copenhagen nursing homes were invited to participate, of which 176 were randomized at baseline. No information is provided for gender distribution at baseline, but of the 125 participants who completed the study, 82 were female and 43 were male, which shows a slight gender imbalance. Nursing home residents who were regularly visited by a dental hygienist were invited to participate in the study if they were not able to brush their teeth themselves, if they allowed the nursing staff to brush their teeth, if they had 5 or more natural teeth, if they had one or more root caries lesion(s), and if they were not bedridden. Two clinical examinations were performed by a single trained and calibrated examiner, at baseline and at 8 months. The follow-up was short (8 months), but relatively complete.
Key Exposure/Study Factor The key exposure of the trial was twice daily professional tooth brushing with fluoridated toothpaste in two concentrations: 5000 and 1450 ppm of fluoride. No information is offered regarding application time and tooth brushing technique, other than that participants had their teeth brushed by nursing staff twice a day. Participants were randomly assigned to either the test study arm (5000 ppm fluoride) or the control study arm (1450 ppm fluoride).
Main Outcome Measure The primary outcome measure was the (mean) numbers of arrested and active root caries lesions for each participant at the 8-month follow-up clinical examination. A 4-variable criteria panel previously developed and tested1 was used to score all lesions, and the scores were then dichotomized to achieve the binary outcome (arrested or active). Authors also studied texture scores related to activity assessment of the lesions as a secondary outcome.
Main Results Significantly more baseline active lesions were arrested during the study period in the 5000 ppm fluoride study arm than in the 1450 ppm fluoride study arm (means = 1.72 and 0.28, respectively, p < 0.00001), while significantly more baseline active lesions remained active during the study period in the 1450 ppm fluoride study arm than in the 5000 ppm fluoride study arm (means = 2.34 and 0.87, respectively, p < 0.00001). Texture scores related well with lesion activity.
Conclusions This study suggests that 5000 ppm fluoride toothpaste is significantly more effective than 1450 ppm fluoride toothpaste for controlling root caries progression and promoting remineralization in teeth of nursing home residents who received twice daily professional tooth brushing.2
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
COMMENTARY AND ANALYSIS Root caries is an important clinical problem for a large proportion of the worldwide adult population. Root caries is more prevalent in older than in younger adults,3-7 with an annual incidence estimated at 26% to 27%.6,8 As the proportion of older adults in the general population increases, and as these older adults retain their teeth longer because of advances in medical and dental health care, more root surfaces become physiologically or pathologically exposed and consequently at risk.6,9-13 There is wide agreement that root caries is likely to become an increasing clinical problem in the next several decades. Therefore clinical studies that expand our knowledge of root caries prevention and management are necessary. Fluoride in its various presentations has been for many years considered the standard of care for caries prevention.14,15 The article by Ekstrand and colleagues reviewed here reports on a clinical study comparing the efficacy of two formulations of fluoride toothpaste (5000 and 1450 ppm) on root caries progression.2 The study was conducted with 125 elderly disabled residents (more residents started the study, but data were only reported on those who actually completed the study) over a period of 8 months. All study participants were residents of nursing homes in the Copenhagen region. Interventions (tooth brushing twice daily) were administered by the nursing staff, while the clinical examinations were all done by one trained study examiner. While this is a timely study done on an important topic, the enthusiasm for the positive results is somewhat reduced due to a few study design limitations. First, the authors seem to refer to the terms efficacy and effectiveness interchangeably throughout the manuscript, which poses a problem. In evidence-based practice, efficacy studies are designed with maximum control over experimental variables, while effectiveness studies are designed to test interventions when applied to more ‘‘real world’’ conditions.16 Translating efficacious practices to routine practice settings to produce effective results is one of the more challenging issues of evidence-based practice. While the authors tested the study interventions in nursing home residents (‘‘real world’’ study participants), the conditions for the study were highly controlled, and therefore this should be characterized as an efficacy study. Second, while the sample size calculations were personlevel based, the outcome measure analyses are performed on a lesion-level basis, which presents a problem because multiple lesions in the same study participant are not independent in terms of treatment effects. Given that the authors do not acknowledge clustering effects in the paper, it is assumed that these were not considered, which weakens the results of the analysis. Third, and importantly, the external validity of the study is compromised by the sampling strategy used, i.e., a convenience sample 178
of disabled nursing home residents in the city of Copenhagen. While this choice of a convenience sample certainly allowed the investigators to achieve a higher level of control over compliance, examination schedules, etc., this sampling strategy considerably limits the generalizability of the results, as it can’t be assumed that the same results would be obtained by applying the intervention in another sample, for example, a group of abled elderly residents who brushed their own teeth, or a group of similarly disabled elderly residents living in a different region, using a different diet regimen, different oral care practices, etc. Last, the study follow-up time is short for a caries trial, and there is a small gender imbalance at the follow-up examination. Aside from the comments pertaining to study design limitations, the paper also reports somewhat unclear definitions of primary and secondary outcomes, there is no mention of absolute and relative effect sizes given the proposed binary outcome (arrested vs. active lesions), and there is a discrepancy between the number of caries lesions recorded both at baseline and at the follow-up examination (page 394, second column, third paragraph shows 396, while page 395, Table 4 shows 394 as the sum of number of lesions). Finally, the authors do not provide trial registry information, where the full trial protocol can be accessed if available, which would have been helpful to elucidate these minor points. On a positive note, the report closely follows the CONSORT checklist for reporting of clinical trials. This study was not a ‘‘pure’’ randomized controlled trial given that it did not include a placebo control arm, but rather used a comparative effectiveness study design with two active interventions. Using a placebo control in this sample population would present ethical problems, as it is well known that fluoride toothpaste is effective in caries prevention. The outcome evaluated is relevant in that the authors clearly show that the stronger fluoride toothpaste had a more positive effect in reducing the activity of already established root caries lesions. Further consideration could have been given to studying the effect of the two interventions on root caries incidence, i.e., new lesions that developed throughout the trial, if any. Taking into account all of the above, oral care providers should consider recommending 5000 ppm fluoride toothpaste for the management of root caries in elderly patients.
REFERENCES 1. Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology 2008;25(2):67-75. 2. Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res 2013;47(5):391-8. 3. Clarkson JE. Epidemiology of root caries. Am J Dent 1995;8(6): 329-34.
December 2013
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE 4. Shay K. Root caries in the older patient: significance, prevention, and treatment. Dent Clin North Am 1997;41(4):763-93. 5. Curzon ME, Preston AJ. Risk groups: nursing bottle caries/caries in the elderly. Caries Res 2004;38(suppl 1):24-33. 6. Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res 2004;83(8):634-8. 7. Thomson WM. Dental caries experience in older people over time: what can the large cohort studies tell us? Br Dent J 2004;196(2): 89-92 [discussion 87]. 8. Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol 2010; 38(5):383-97. 9. Hamasha AA, Warren JJ, Hand JS, Levy SM. Coronal and root caries in the older Iowans: 9- to 11-year incidence. Spec Care Dentist 2005;25(2):106-10. 10. Saunders RH Jr, Meyerowitz C. Dental caries in older adults. Dent Clin North Am 2005;49(2):293-308. 11. Chalmers JM, Carter KD, Spencer AJ. Caries incidence and increments in Adelaide nursing home residents. Spec Care Dentist 2005;25(2):96-105. 12. Fure S. Ten-year cross-sectional and incidence study of coronal and root caries and some related factors in elderly Swedish individuals. Gerodontology 2004;21(3):130-40.
Volume 13, Number 4
13. Drake CW, Beck JD, Lawrence HP, Koch GG. Three-year coronal caries incidence and risk factors in North Carolina elderly. Caries Res 1997;31(1):1-7. 14. ten Cate JM. Contemporary perspective on the use of fluoride products in caries prevention. Br Dent J 2013;214(4):161-7. 15. Zimmer S, Jahn KR, Barthel CR. Recommendations for the use of fluoride in caries prevention. Oral Health Prev Dentistry 2003;1(1):45-51. 16. Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry 2009;8(1):34-5.
REVIEWER Andre V. Ritter, DDS, MS, MBA Professor and Graduate Program Director, Department of Operative Dentistry, University of North Carolina School of Dentistry, 441 Brauer Hall, CB#7450, Chapel Hill, NC 27599-7450, USA, Tel.: þ1 919 537 3987; fax: þ1 919 537 3939 [email protected]
179
ARTICLE ANALYSIS & EVALUATION ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION A randomized clinical trial of the anti-caries efficacy of 5000 compared to 1450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. Caries Res 2013;47(5):391-98.
REVIEWER Andr e V. Ritter, DDS, MS, MBA
PURPOSE/QUESTION Is 5000 ppm fluoridated toothpaste used twice daily more efficacious than 1450 ppm fluoridated toothpaste used twice daily for controlling root caries progression in elderly disabled nursing home residents?
SOURCE OF FUNDING This study was supported by a donation from Colgate Palmolive, manufacturer of the two toothpaste interventions
TYPE OF STUDY/DESIGN This was a randomized clinical trial done with a convenience sample, with elements of comparative effectiveness design
LEVEL OF EVIDENCE Level 2: Limited-quality, patient-oriented evidence
STRENGTH OF RECOMMENDATION GRADE Not applicable J Evid Base Dent Pract 2013;13:177-179 1532-3382/$36.00 Ó 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jebdp.2013.10.014
The Efficacy of Fluoride on Root Caries Progression May Be Dose-dependent SUMMARY Subjects One hundred eighty-three residents of six Copenhagen nursing homes were invited to participate, of which 176 were randomized at baseline. No information is provided for gender distribution at baseline, but of the 125 participants who completed the study, 82 were female and 43 were male, which shows a slight gender imbalance. Nursing home residents who were regularly visited by a dental hygienist were invited to participate in the study if they were not able to brush their teeth themselves, if they allowed the nursing staff to brush their teeth, if they had 5 or more natural teeth, if they had one or more root caries lesion(s), and if they were not bedridden. Two clinical examinations were performed by a single trained and calibrated examiner, at baseline and at 8 months. The follow-up was short (8 months), but relatively complete.
Key Exposure/Study Factor The key exposure of the trial was twice daily professional tooth brushing with fluoridated toothpaste in two concentrations: 5000 and 1450 ppm of fluoride. No information is offered regarding application time and tooth brushing technique, other than that participants had their teeth brushed by nursing staff twice a day. Participants were randomly assigned to either the test study arm (5000 ppm fluoride) or the control study arm (1450 ppm fluoride).
Main Outcome Measure The primary outcome measure was the (mean) numbers of arrested and active root caries lesions for each participant at the 8-month follow-up clinical examination. A 4-variable criteria panel previously developed and tested1 was used to score all lesions, and the scores were then dichotomized to achieve the binary outcome (arrested or active). Authors also studied texture scores related to activity assessment of the lesions as a secondary outcome.
Main Results Significantly more baseline active lesions were arrested during the study period in the 5000 ppm fluoride study arm than in the 1450 ppm fluoride study arm (means = 1.72 and 0.28, respectively, p < 0.00001), while significantly more baseline active lesions remained active during the study period in the 1450 ppm fluoride study arm than in the 5000 ppm fluoride study arm (means = 2.34 and 0.87, respectively, p < 0.00001). Texture scores related well with lesion activity.
Conclusions This study suggests that 5000 ppm fluoride toothpaste is significantly more effective than 1450 ppm fluoride toothpaste for controlling root caries progression and promoting remineralization in teeth of nursing home residents who received twice daily professional tooth brushing.2
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
COMMENTARY AND ANALYSIS Root caries is an important clinical problem for a large proportion of the worldwide adult population. Root caries is more prevalent in older than in younger adults,3-7 with an annual incidence estimated at 26% to 27%.6,8 As the proportion of older adults in the general population increases, and as these older adults retain their teeth longer because of advances in medical and dental health care, more root surfaces become physiologically or pathologically exposed and consequently at risk.6,9-13 There is wide agreement that root caries is likely to become an increasing clinical problem in the next several decades. Therefore clinical studies that expand our knowledge of root caries prevention and management are necessary. Fluoride in its various presentations has been for many years considered the standard of care for caries prevention.14,15 The article by Ekstrand and colleagues reviewed here reports on a clinical study comparing the efficacy of two formulations of fluoride toothpaste (5000 and 1450 ppm) on root caries progression.2 The study was conducted with 125 elderly disabled residents (more residents started the study, but data were only reported on those who actually completed the study) over a period of 8 months. All study participants were residents of nursing homes in the Copenhagen region. Interventions (tooth brushing twice daily) were administered by the nursing staff, while the clinical examinations were all done by one trained study examiner. While this is a timely study done on an important topic, the enthusiasm for the positive results is somewhat reduced due to a few study design limitations. First, the authors seem to refer to the terms efficacy and effectiveness interchangeably throughout the manuscript, which poses a problem. In evidence-based practice, efficacy studies are designed with maximum control over experimental variables, while effectiveness studies are designed to test interventions when applied to more ‘‘real world’’ conditions.16 Translating efficacious practices to routine practice settings to produce effective results is one of the more challenging issues of evidence-based practice. While the authors tested the study interventions in nursing home residents (‘‘real world’’ study participants), the conditions for the study were highly controlled, and therefore this should be characterized as an efficacy study. Second, while the sample size calculations were personlevel based, the outcome measure analyses are performed on a lesion-level basis, which presents a problem because multiple lesions in the same study participant are not independent in terms of treatment effects. Given that the authors do not acknowledge clustering effects in the paper, it is assumed that these were not considered, which weakens the results of the analysis. Third, and importantly, the external validity of the study is compromised by the sampling strategy used, i.e., a convenience sample 178
of disabled nursing home residents in the city of Copenhagen. While this choice of a convenience sample certainly allowed the investigators to achieve a higher level of control over compliance, examination schedules, etc., this sampling strategy considerably limits the generalizability of the results, as it can’t be assumed that the same results would be obtained by applying the intervention in another sample, for example, a group of abled elderly residents who brushed their own teeth, or a group of similarly disabled elderly residents living in a different region, using a different diet regimen, different oral care practices, etc. Last, the study follow-up time is short for a caries trial, and there is a small gender imbalance at the follow-up examination. Aside from the comments pertaining to study design limitations, the paper also reports somewhat unclear definitions of primary and secondary outcomes, there is no mention of absolute and relative effect sizes given the proposed binary outcome (arrested vs. active lesions), and there is a discrepancy between the number of caries lesions recorded both at baseline and at the follow-up examination (page 394, second column, third paragraph shows 396, while page 395, Table 4 shows 394 as the sum of number of lesions). Finally, the authors do not provide trial registry information, where the full trial protocol can be accessed if available, which would have been helpful to elucidate these minor points. On a positive note, the report closely follows the CONSORT checklist for reporting of clinical trials. This study was not a ‘‘pure’’ randomized controlled trial given that it did not include a placebo control arm, but rather used a comparative effectiveness study design with two active interventions. Using a placebo control in this sample population would present ethical problems, as it is well known that fluoride toothpaste is effective in caries prevention. The outcome evaluated is relevant in that the authors clearly show that the stronger fluoride toothpaste had a more positive effect in reducing the activity of already established root caries lesions. Further consideration could have been given to studying the effect of the two interventions on root caries incidence, i.e., new lesions that developed throughout the trial, if any. Taking into account all of the above, oral care providers should consider recommending 5000 ppm fluoride toothpaste for the management of root caries in elderly patients.
REFERENCES 1. Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology 2008;25(2):67-75. 2. Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res 2013;47(5):391-8. 3. Clarkson JE. Epidemiology of root caries. Am J Dent 1995;8(6): 329-34.
December 2013
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE 4. Shay K. Root caries in the older patient: significance, prevention, and treatment. Dent Clin North Am 1997;41(4):763-93. 5. Curzon ME, Preston AJ. Risk groups: nursing bottle caries/caries in the elderly. Caries Res 2004;38(suppl 1):24-33. 6. Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res 2004;83(8):634-8. 7. Thomson WM. Dental caries experience in older people over time: what can the large cohort studies tell us? Br Dent J 2004;196(2): 89-92 [discussion 87]. 8. Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol 2010; 38(5):383-97. 9. Hamasha AA, Warren JJ, Hand JS, Levy SM. Coronal and root caries in the older Iowans: 9- to 11-year incidence. Spec Care Dentist 2005;25(2):106-10. 10. Saunders RH Jr, Meyerowitz C. Dental caries in older adults. Dent Clin North Am 2005;49(2):293-308. 11. Chalmers JM, Carter KD, Spencer AJ. Caries incidence and increments in Adelaide nursing home residents. Spec Care Dentist 2005;25(2):96-105. 12. Fure S. Ten-year cross-sectional and incidence study of coronal and root caries and some related factors in elderly Swedish individuals. Gerodontology 2004;21(3):130-40.
Volume 13, Number 4
13. Drake CW, Beck JD, Lawrence HP, Koch GG. Three-year coronal caries incidence and risk factors in North Carolina elderly. Caries Res 1997;31(1):1-7. 14. ten Cate JM. Contemporary perspective on the use of fluoride products in caries prevention. Br Dent J 2013;214(4):161-7. 15. Zimmer S, Jahn KR, Barthel CR. Recommendations for the use of fluoride in caries prevention. Oral Health Prev Dentistry 2003;1(1):45-51. 16. Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry 2009;8(1):34-5.
REVIEWER Andre V. Ritter, DDS, MS, MBA Professor and Graduate Program Director, Department of Operative Dentistry, University of North Carolina School of Dentistry, 441 Brauer Hall, CB#7450, Chapel Hill, NC 27599-7450, USA, Tel.: þ1 919 537 3987; fax: þ1 919 537 3939 [email protected]
179