- Email: [email protected]
AIR-ABRASION TREATMENT
L E T T E R S
M.P.H. Parivash Nourjah, Ph.D. U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Postmarketing Drug Risk Assessment Rockville, Md. 1. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55. 2. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 3. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 4. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 5. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press).
Authors’ response: We appreciate the comments of Drs. Brinker, Bonnel, Feight and Nourjah, and we compliment Drs. Brinker and Bonnel on their upcoming publication in the American Journal of Gastroenterology.1 While we certainly agree with them that the general tolerability of the COX-2 inhibitors appears to be no better than traditional NSAIDs, the results of the CLASS2 and VIGOR3 trials unambiguously and undebatably indicate that six to 12 months’ worth of dosing with either celecoxib or rofecoxib decreased the incidence of significant GI bleeding, obstructions, perforations and symptomatic ulcers by approximately 50 to 60 percent compared with the traditional NSAIDs ibuprofen, diclofenac and naproxen. 1502
While both celecoxib and rofecoxib have been associated with significant GI events including deaths,1,4,5 a reduction anywhere near 50 percent in the estimated 107,000 hospitalizations and 16,500 deaths annually thought to be caused by the gastropathy induced by chronic NSAID ingestion6 would represent a tremendous health care benefit. We agree that the findings of the CLASS and VIGOR trials,2,3 performed in a relatively healthy patient population with a mean age of 60 years, may not necessarily be applicable to patients at the highest risk of GI complications, including those with previous ulcers, those on concomitant anticoagulant therapy, those on other NSAIDs and those with advanced age. More research is needed to see if this safety advantage does in fact hold in an older, “more fragile” patient population. Paul Moore, D.M.D, Ph.D., M.P.H. Professor of Pharmacology Department of Public Health Dentistry University of Pittsburgh School of Dental Medicine Elliot V. Hersh, D.M.D., M.S., Ph.D. Associate Professor of Pharmacology and Director Pharmacology and Clinical Therapeutics University of Pennsylvania School of Dental Medicine Philadelphia 1. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press). 2. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55.
3. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 4. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 5. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 6. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105(1B):S31-8.
FAREWELL, DR. MESKIN
I have enjoyed all 130 of Dr. Meskin’s editorials (“Pluses” July JADA). Congratulations and thanks for his work—a tribute to our profession. Frank Spalding, D.D.S. Peoria, Ill. I would like to say that the potential audience for JADA is much higher than Dr. Meskin thought in his editorial, “Pluses” (July JADA). I am an undergraduate senior and I have been reading JADA online since my summer vacation started. I and my friends who also wish to be dentists read JADA as a resource to prepare for our dental school admission test. I just want to say thank you for Dr. Meskin’s professional opinions on subjects that are new and fascinating to me. I learn so much by reading JADA. His dedicated service as editor is never going to be “a void.” Christopher Tiu Laie, Hawaii AIR-ABRASION TREATMENT
Dr. James Hamilton and colleagues reported on a 12-month
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
L E T T E R S
study of air-abrasion treatment of questionable carious lesions (“A Clinical Evaluation of AirAbrasion Treatment of Questionable Carious Lesions: A 12-Month Report,” June JADA). Their data indicated that they enrolled 223 teeth in the study and classified each one as having “a questionable incipient pit-and-fissure carious lesion.” They then assigned 113 of these to be treated with air abrasion. Of the 113 treated teeth, the investigators found that 50 teeth (44 percent) had dentinal caries! Eight of those 50 (16 percent) had “more than minimal extension into dentin.” The conclusion stated by these investigators is that “early operative intervention should not be recommended until proven clinical benefits have been demonstrated.” How much better demonstration do they need? A diagnosis that is only 56 percent accurate is unacceptable in my office. How can they possibly accept only 56 percent accuracy in their clinical diagnosis of decay? To find that 44 percent of those teeth thought to be questionable are indeed decayed should tell everyone that there must be something wrong with the diagnostic criteria. My conclusion when reading such data is this: by all means, treat each of those questionable lesions. I would even suggest that every pit and fissure be explored using the finest of airabrasion tips and significant magnification (×3.5 at least). D. Alan Hays, D.M.D. Umatilla, Fla. Authors’ response: Dr. Hays may have misunderstood
our conclusion, which was, “Judged on the basis of the weight of the preparation impression (a surrogate measure of volume), there was no benefit gained from early treatment of questionable carious lesions.” That is, tooth structure was not conserved by early treatment. We are not recommending that carious lesions into dentin not be diagnosed and treated, but in our study, early treatment led to 56 percent of those teeth being treated unnecessarily by current standards. This can be viewed as a needless expense in terms of the patient’s time and, in a fee-for-service environment, the patient’s money. Equally important is the necessity of continued maintenance1,2 of these restorations, which will lead to additional losses. There is also the unnecessary loss of tooth structure in 56 percent of the teeth treated, which carries some ethical considerations. Considering the volume of tooth structure lost due to the unnecessary early operative intervention (not analyzed in our study) of 56 percent of the teeth, it is felt that additional tooth structure was lost, not conserved, by early treatment. This is a major negative factor for the patient, without any proven benefit. James C. Hamilton, D.D.S. Assistant Professor Joseph B. Dennison, D.D.S., M.S. Professor Department of Cariology, Restorative Sciences and Endodontics University of Michigan School of Dentistry Ann Arbor
1. Romcke RG, Lewis DW, Maze BD, Vickerson RA. Retention and maintenance of fissure sealants over 10 years. J Can Dent Assoc 1990;56(3):235-7. 2. Wendt LK, Koch G, Birkhed D. Replacements of restorations in the primary and young permanent dentition. Swed Dent J 1998;22(4):149-55.
MORE ON AIR ABRASION
Dr. Hamilton and his co-investigators have composed an elegant paper, but its results are suspect and its conclusion is not clinically applicable by a conscientious dentist. Regarding the results: The element of air abrasion seems to be somewhat of a distraction in this study. It appears that the results would have been the same whether the faulty pits and fissures were cleaned with air abrasion or small round burs. The differential between 44 percent dentin decay in the experimental group and 11 percent in the control group is too great to be accounted for by anything other than faulty randomization between the experimental and control groups or inadequate criteria for treatment of teeth in the control group. There is no discussion in the article about how teeth in the control group were selected for treatment, and the need for treatment in the experimental group was not predictable. Undertreatment of teeth in the control group is likely. The suggestion that increased remineralization due to greater availability of fluoride seems inappropriate. Monitoring interproximal enamel lesions that have not reached the dentin is one thing. Postulating remineralization of pit-andfissure caries that may have invaded the dentin and is not easily visualized radiographically is quite another.
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
1503
M.P.H. Parivash Nourjah, Ph.D. U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Postmarketing Drug Risk Assessment Rockville, Md. 1. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55. 2. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 3. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 4. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 5. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press).
Authors’ response: We appreciate the comments of Drs. Brinker, Bonnel, Feight and Nourjah, and we compliment Drs. Brinker and Bonnel on their upcoming publication in the American Journal of Gastroenterology.1 While we certainly agree with them that the general tolerability of the COX-2 inhibitors appears to be no better than traditional NSAIDs, the results of the CLASS2 and VIGOR3 trials unambiguously and undebatably indicate that six to 12 months’ worth of dosing with either celecoxib or rofecoxib decreased the incidence of significant GI bleeding, obstructions, perforations and symptomatic ulcers by approximately 50 to 60 percent compared with the traditional NSAIDs ibuprofen, diclofenac and naproxen. 1502
While both celecoxib and rofecoxib have been associated with significant GI events including deaths,1,4,5 a reduction anywhere near 50 percent in the estimated 107,000 hospitalizations and 16,500 deaths annually thought to be caused by the gastropathy induced by chronic NSAID ingestion6 would represent a tremendous health care benefit. We agree that the findings of the CLASS and VIGOR trials,2,3 performed in a relatively healthy patient population with a mean age of 60 years, may not necessarily be applicable to patients at the highest risk of GI complications, including those with previous ulcers, those on concomitant anticoagulant therapy, those on other NSAIDs and those with advanced age. More research is needed to see if this safety advantage does in fact hold in an older, “more fragile” patient population. Paul Moore, D.M.D, Ph.D., M.P.H. Professor of Pharmacology Department of Public Health Dentistry University of Pittsburgh School of Dental Medicine Elliot V. Hersh, D.M.D., M.S., Ph.D. Associate Professor of Pharmacology and Director Pharmacology and Clinical Therapeutics University of Pennsylvania School of Dental Medicine Philadelphia 1. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press). 2. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55.
3. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 4. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 5. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 6. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105(1B):S31-8.
FAREWELL, DR. MESKIN
I have enjoyed all 130 of Dr. Meskin’s editorials (“Pluses” July JADA). Congratulations and thanks for his work—a tribute to our profession. Frank Spalding, D.D.S. Peoria, Ill. I would like to say that the potential audience for JADA is much higher than Dr. Meskin thought in his editorial, “Pluses” (July JADA). I am an undergraduate senior and I have been reading JADA online since my summer vacation started. I and my friends who also wish to be dentists read JADA as a resource to prepare for our dental school admission test. I just want to say thank you for Dr. Meskin’s professional opinions on subjects that are new and fascinating to me. I learn so much by reading JADA. His dedicated service as editor is never going to be “a void.” Christopher Tiu Laie, Hawaii AIR-ABRASION TREATMENT
Dr. James Hamilton and colleagues reported on a 12-month
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
L E T T E R S
study of air-abrasion treatment of questionable carious lesions (“A Clinical Evaluation of AirAbrasion Treatment of Questionable Carious Lesions: A 12-Month Report,” June JADA). Their data indicated that they enrolled 223 teeth in the study and classified each one as having “a questionable incipient pit-and-fissure carious lesion.” They then assigned 113 of these to be treated with air abrasion. Of the 113 treated teeth, the investigators found that 50 teeth (44 percent) had dentinal caries! Eight of those 50 (16 percent) had “more than minimal extension into dentin.” The conclusion stated by these investigators is that “early operative intervention should not be recommended until proven clinical benefits have been demonstrated.” How much better demonstration do they need? A diagnosis that is only 56 percent accurate is unacceptable in my office. How can they possibly accept only 56 percent accuracy in their clinical diagnosis of decay? To find that 44 percent of those teeth thought to be questionable are indeed decayed should tell everyone that there must be something wrong with the diagnostic criteria. My conclusion when reading such data is this: by all means, treat each of those questionable lesions. I would even suggest that every pit and fissure be explored using the finest of airabrasion tips and significant magnification (×3.5 at least). D. Alan Hays, D.M.D. Umatilla, Fla. Authors’ response: Dr. Hays may have misunderstood
our conclusion, which was, “Judged on the basis of the weight of the preparation impression (a surrogate measure of volume), there was no benefit gained from early treatment of questionable carious lesions.” That is, tooth structure was not conserved by early treatment. We are not recommending that carious lesions into dentin not be diagnosed and treated, but in our study, early treatment led to 56 percent of those teeth being treated unnecessarily by current standards. This can be viewed as a needless expense in terms of the patient’s time and, in a fee-for-service environment, the patient’s money. Equally important is the necessity of continued maintenance1,2 of these restorations, which will lead to additional losses. There is also the unnecessary loss of tooth structure in 56 percent of the teeth treated, which carries some ethical considerations. Considering the volume of tooth structure lost due to the unnecessary early operative intervention (not analyzed in our study) of 56 percent of the teeth, it is felt that additional tooth structure was lost, not conserved, by early treatment. This is a major negative factor for the patient, without any proven benefit. James C. Hamilton, D.D.S. Assistant Professor Joseph B. Dennison, D.D.S., M.S. Professor Department of Cariology, Restorative Sciences and Endodontics University of Michigan School of Dentistry Ann Arbor
1. Romcke RG, Lewis DW, Maze BD, Vickerson RA. Retention and maintenance of fissure sealants over 10 years. J Can Dent Assoc 1990;56(3):235-7. 2. Wendt LK, Koch G, Birkhed D. Replacements of restorations in the primary and young permanent dentition. Swed Dent J 1998;22(4):149-55.
MORE ON AIR ABRASION
Dr. Hamilton and his co-investigators have composed an elegant paper, but its results are suspect and its conclusion is not clinically applicable by a conscientious dentist. Regarding the results: The element of air abrasion seems to be somewhat of a distraction in this study. It appears that the results would have been the same whether the faulty pits and fissures were cleaned with air abrasion or small round burs. The differential between 44 percent dentin decay in the experimental group and 11 percent in the control group is too great to be accounted for by anything other than faulty randomization between the experimental and control groups or inadequate criteria for treatment of teeth in the control group. There is no discussion in the article about how teeth in the control group were selected for treatment, and the need for treatment in the experimental group was not predictable. Undertreatment of teeth in the control group is likely. The suggestion that increased remineralization due to greater availability of fluoride seems inappropriate. Monitoring interproximal enamel lesions that have not reached the dentin is one thing. Postulating remineralization of pit-andfissure caries that may have invaded the dentin and is not easily visualized radiographically is quite another.
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
1503