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Essential Dental Treatment (EDT) in Pregnant Women during the Second Trimester Is Not Associated with an Increased Risk of Serious Adverse Pregnancy Outcomes or Medical Events
DIAGNOSIS/TREATMENT/PROGNOSIS
ARTICLE ANALYSIS & EVALUATION ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION Examining the safety of dental treatment in pregnant women. Michalowicz BS, DiAngelis AJ, Novak MJ, Buchanan W, Papapanou PN, Mitchell DA, et al. J Am Dent Assoc 2008;139(6):685-95.
REVIEWER Martha E. Nunn, DDS, Phd
PURPOSE/QUESTION To evaluate safety outcomes from a trial in which pregnant women with periodontitis received scaling and root planning and other dental treatments.
SOURCE OF FUNDING
Essential Dental Treatment (EDT) in Pregnant Women during the Second Trimester Is Not Associated with an Increased Risk of Serious Adverse Pregnancy Outcomes or Medical Events SUMMARY Subjects A total of 814 of 823 subjects initially enrolled in the OPT. Seven subjects were lost to follow-up and 2 subjects withdrew their consents. Excluded subjects were (1) women with multiple fetuses, (2) women requiring antibiotic prophylaxis before treatment, (3) women with a medical condition that precluded elective dental treatment, and (4) women who were likely to have fewer than 20 remaining teeth after treatment of moderate-to-severe caries, abscesses, or other nonperiodontal pathoses.
Exposure Essential dental treatment (EDT) between 13 and 21 weeks’ gestation.
Main Outcome Measure Adverse pregnancy outcomes.
This study uses data from the Obstetrics and Periodontal Therapy Trial (OPT) that was supported by government funding from NIH/ NIDCR grant U01DE014338.
Main Results EDT between 13 and 21 weeks’ gestation was not significantly associated with any adverse pregnancy outcome (P > .10).
Conclusions TYPE OF STUDY/DESIGN Cohort study that uses data from the OPT, a multicenter randomized controlled clinical trial, to evaluate the effect of periodontal therapy on preterm birth
LEVEL OF EVIDENCE Level 2: Limited-quality, patientoriented evidence.
STRENGTH OF RECOMMENDATION GRADE Grade B: Inconsistent or limitedquality patient-oriented evidence. J Evid Base Dent Pract 2009;9:91-92 1532-3382/$34.00 Ó 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2009.03.014
EDT between 13 and 21 weeks’ gestation does not present a significant risk of any adverse medical or pregnancy outcome.
COMMENTARY AND ANALYSIS The primary purpose of this study was to evaluate safety outcomes of EDT among pregnant women originally recruited for the multicenter OPT conducted by Michalowicz et al.1 The current study by Michalowicz et al2 was conducted secondarily to the OPT to compare adverse medical and pregnancy outcomes among pregnant women who completed EDT during pregnancy and pregnant women who did not need or did not complete EDT during pregnancy. Although the original OPT involved randomization of pregnant women with periodontitis to receive nonsurgical periodontal scaling and root planing either between 13 and 21 weeks’ gestation or following delivery with the rate of preterm delivery compared between the 2 groups, the current study to evaluate the role of EDT to adverse medical and pregnancy outcomes did not include randomization to EDT. To address imbalances between women receiving and not receiving EDT, propensity-score stratification was used to adjust for a woman’s likelihood of receiving EDT. For this study, adverse medical events included hospitalizations for more than 24 hours for any reason judged to be a serious adverse event by the relevant institutional review board, regardless of its relationship to the study, for a variety of reasons,
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
including uncontrolled diabetes, cholestasis, ovarian cysts, preeclampsia, chorioamnionitis, pancreatitis, and pyelonephritis. Adverse pregnancy outcomes were divided into 3 types of events: (1) pregnancies ending in nonlive birth that included spontaneous abortions and stillbirths, (2) preterm birth before 37 weeks’ gestation, and (3) fetal or congenital anomaly. No significant association was found between EDT and any adverse medical or pregnancy outcome. Further analysis included stratification of EDT by periodontal treatment group as well as evaluation of the effect of topical anesthetic and local anesthetic on adverse pregnancy outcomes. Neither topical anesthetic alone nor local anesthetic was associated with an increase in any adverse medical or pregnancy outcomes (P > .10 for all adverse medical and pregnancy outcomes). Although the general consensus of obstetricians is that routine dental care in pregnant women poses minimal risk after 8 weeks’ gestation, dentists and pregnant women often defer necessary dental treatment until after delivery.3 To our knowledge, this study is the first to examine adverse medical and pregnancy outcomes associated with EDT during pregnancy. However, following landmark studies by Offenbacher et al,4,5 which showed a significant association between periodontal disease and an increased risk for premature birth and low birth weight, several clinical trials were launched to investigate whether treatment of periodontal disease in pregnant women could reduce the risk of preterm birth. In addition to the OPT, 3 other randomized clinical trials should help to clarify more precisely the effect of nonsurgical periodontal therapy on the risk of preterm birth.6-8 There are several limitations to the current study. First, the low rate of specific adverse pregnancy outcomes, such as spontaneous abortion and stillbirth, limits the inference that one can draw for specific adverse outcomes because of lack of power. A sample size of several thousand instead of several hundred would be necessary to investigate specific rare adverse outcomes. Second, the restriction of the OPT to pregnant women with periodontitis limits inference somewhat because the greater risk factor of periodontitis may have masked any risk presented by EDT. However, because the rates of adverse medical and pregnancy outcomes were similar across periodontal treatment groups, it is doubtful that the presence of periodontitis was such a strong risk factor that it precluded finding any association between EDT and risk of adverse medical or pregnancy outcomes. In addition to the limitations of the study, several strengths are worth noting. First, this is the first clinical study to demonstrate the safety of EDT between 13 and
92
21 weeks’ gestation. Second, the robust nature of the results is exemplified by similar odds ratios obtained before and after stratification by EDT propensity score, which strengthens the inference that there is not a significant risk for adverse medical or pregnancy outcomes from EDT between 13 and 21 weeks’ gestation. In conclusion, because of the meticulous nature of the OPT as well as the careful use of stratification by EDT propensity score, this study presents compelling evidence that EDT between 13 and 21 weeks’ gestation in otherwise healthy women presents little risk of adverse medical or pregnancy outcomes. In addition, the analysis of the use of topical and local anesthetics in periodontal treatment demonstrates the safety of these 2 drugs between 13 and 21 weeks’ gestation.
REFERENCES 1. Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, et al. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med 2006;355(18):1885-94. 2. Michalowicz BS, DiAngelis AJ, Novak MJ, Buchanan W, Papapanou PN, Mitchell DA, et al. Examining the safety of dental treatment in pregnant women. J Am Dent Assoc 2008;139(6):685-95. 3. Shrout MK, Comer RW, Powell BJ, McCoy BP. Treating the pregnant dental patient: four basic rules addressed. J Am Dent Assoc 1992;123(5):75-80. 4. Offenbacher S, Katz V, Fertik G, Collins J, Boyd D, Maynor G, et al. Periodontal infection as a possible risk factor for preterm low birth weight. J Periodontol 1996;67(10 Suppl):1103-13. 5. Offenbacher S, Lieff S, Boggess KA, Murtha AP, Madianos PN, Champagne CM, et al. Maternal periodontitis and prematurity. Part I: Obstetric outcome of prematurity and growth restriction. Ann Periodontol 2001;6(1):164-74. 6. Prevention of pre-term birth by treatment of periodontal disease. NCT00133926. Available at: http://clinicaltrials.gov/ct2/show/ NCT00133926. Accessed December 5, 2008. 7. MOTOR: Maternal oral therapy to reduce obstetric risk. NCT00097656. Available at: http://clinicaltrials.gov/ct2/show/ NCT00097656. Accessed December 5, 2008. 8. Periodontal infection and prematurity study. NCT00116974. Available at: http://clinicaltrials.gov/ct2/show/NCT00116974. Accessed December 5, 2008.
REVIEWER Martha E. Nunn, DDS, PhD Director, Biometry Core, Northeast Center for Research to Evaluate and Eliminate Dental Disparities (CREEDD), Associate Professor, Health Policy and Health Services Research, Goldman School of Dental Medicine, Boston University, 715 Albany, 560, Boston, MA 02118 [email protected]
June 2009
ARTICLE ANALYSIS & EVALUATION ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION Examining the safety of dental treatment in pregnant women. Michalowicz BS, DiAngelis AJ, Novak MJ, Buchanan W, Papapanou PN, Mitchell DA, et al. J Am Dent Assoc 2008;139(6):685-95.
REVIEWER Martha E. Nunn, DDS, Phd
PURPOSE/QUESTION To evaluate safety outcomes from a trial in which pregnant women with periodontitis received scaling and root planning and other dental treatments.
SOURCE OF FUNDING
Essential Dental Treatment (EDT) in Pregnant Women during the Second Trimester Is Not Associated with an Increased Risk of Serious Adverse Pregnancy Outcomes or Medical Events SUMMARY Subjects A total of 814 of 823 subjects initially enrolled in the OPT. Seven subjects were lost to follow-up and 2 subjects withdrew their consents. Excluded subjects were (1) women with multiple fetuses, (2) women requiring antibiotic prophylaxis before treatment, (3) women with a medical condition that precluded elective dental treatment, and (4) women who were likely to have fewer than 20 remaining teeth after treatment of moderate-to-severe caries, abscesses, or other nonperiodontal pathoses.
Exposure Essential dental treatment (EDT) between 13 and 21 weeks’ gestation.
Main Outcome Measure Adverse pregnancy outcomes.
This study uses data from the Obstetrics and Periodontal Therapy Trial (OPT) that was supported by government funding from NIH/ NIDCR grant U01DE014338.
Main Results EDT between 13 and 21 weeks’ gestation was not significantly associated with any adverse pregnancy outcome (P > .10).
Conclusions TYPE OF STUDY/DESIGN Cohort study that uses data from the OPT, a multicenter randomized controlled clinical trial, to evaluate the effect of periodontal therapy on preterm birth
LEVEL OF EVIDENCE Level 2: Limited-quality, patientoriented evidence.
STRENGTH OF RECOMMENDATION GRADE Grade B: Inconsistent or limitedquality patient-oriented evidence. J Evid Base Dent Pract 2009;9:91-92 1532-3382/$34.00 Ó 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2009.03.014
EDT between 13 and 21 weeks’ gestation does not present a significant risk of any adverse medical or pregnancy outcome.
COMMENTARY AND ANALYSIS The primary purpose of this study was to evaluate safety outcomes of EDT among pregnant women originally recruited for the multicenter OPT conducted by Michalowicz et al.1 The current study by Michalowicz et al2 was conducted secondarily to the OPT to compare adverse medical and pregnancy outcomes among pregnant women who completed EDT during pregnancy and pregnant women who did not need or did not complete EDT during pregnancy. Although the original OPT involved randomization of pregnant women with periodontitis to receive nonsurgical periodontal scaling and root planing either between 13 and 21 weeks’ gestation or following delivery with the rate of preterm delivery compared between the 2 groups, the current study to evaluate the role of EDT to adverse medical and pregnancy outcomes did not include randomization to EDT. To address imbalances between women receiving and not receiving EDT, propensity-score stratification was used to adjust for a woman’s likelihood of receiving EDT. For this study, adverse medical events included hospitalizations for more than 24 hours for any reason judged to be a serious adverse event by the relevant institutional review board, regardless of its relationship to the study, for a variety of reasons,
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
including uncontrolled diabetes, cholestasis, ovarian cysts, preeclampsia, chorioamnionitis, pancreatitis, and pyelonephritis. Adverse pregnancy outcomes were divided into 3 types of events: (1) pregnancies ending in nonlive birth that included spontaneous abortions and stillbirths, (2) preterm birth before 37 weeks’ gestation, and (3) fetal or congenital anomaly. No significant association was found between EDT and any adverse medical or pregnancy outcome. Further analysis included stratification of EDT by periodontal treatment group as well as evaluation of the effect of topical anesthetic and local anesthetic on adverse pregnancy outcomes. Neither topical anesthetic alone nor local anesthetic was associated with an increase in any adverse medical or pregnancy outcomes (P > .10 for all adverse medical and pregnancy outcomes). Although the general consensus of obstetricians is that routine dental care in pregnant women poses minimal risk after 8 weeks’ gestation, dentists and pregnant women often defer necessary dental treatment until after delivery.3 To our knowledge, this study is the first to examine adverse medical and pregnancy outcomes associated with EDT during pregnancy. However, following landmark studies by Offenbacher et al,4,5 which showed a significant association between periodontal disease and an increased risk for premature birth and low birth weight, several clinical trials were launched to investigate whether treatment of periodontal disease in pregnant women could reduce the risk of preterm birth. In addition to the OPT, 3 other randomized clinical trials should help to clarify more precisely the effect of nonsurgical periodontal therapy on the risk of preterm birth.6-8 There are several limitations to the current study. First, the low rate of specific adverse pregnancy outcomes, such as spontaneous abortion and stillbirth, limits the inference that one can draw for specific adverse outcomes because of lack of power. A sample size of several thousand instead of several hundred would be necessary to investigate specific rare adverse outcomes. Second, the restriction of the OPT to pregnant women with periodontitis limits inference somewhat because the greater risk factor of periodontitis may have masked any risk presented by EDT. However, because the rates of adverse medical and pregnancy outcomes were similar across periodontal treatment groups, it is doubtful that the presence of periodontitis was such a strong risk factor that it precluded finding any association between EDT and risk of adverse medical or pregnancy outcomes. In addition to the limitations of the study, several strengths are worth noting. First, this is the first clinical study to demonstrate the safety of EDT between 13 and
92
21 weeks’ gestation. Second, the robust nature of the results is exemplified by similar odds ratios obtained before and after stratification by EDT propensity score, which strengthens the inference that there is not a significant risk for adverse medical or pregnancy outcomes from EDT between 13 and 21 weeks’ gestation. In conclusion, because of the meticulous nature of the OPT as well as the careful use of stratification by EDT propensity score, this study presents compelling evidence that EDT between 13 and 21 weeks’ gestation in otherwise healthy women presents little risk of adverse medical or pregnancy outcomes. In addition, the analysis of the use of topical and local anesthetics in periodontal treatment demonstrates the safety of these 2 drugs between 13 and 21 weeks’ gestation.
REFERENCES 1. Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, et al. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med 2006;355(18):1885-94. 2. Michalowicz BS, DiAngelis AJ, Novak MJ, Buchanan W, Papapanou PN, Mitchell DA, et al. Examining the safety of dental treatment in pregnant women. J Am Dent Assoc 2008;139(6):685-95. 3. Shrout MK, Comer RW, Powell BJ, McCoy BP. Treating the pregnant dental patient: four basic rules addressed. J Am Dent Assoc 1992;123(5):75-80. 4. Offenbacher S, Katz V, Fertik G, Collins J, Boyd D, Maynor G, et al. Periodontal infection as a possible risk factor for preterm low birth weight. J Periodontol 1996;67(10 Suppl):1103-13. 5. Offenbacher S, Lieff S, Boggess KA, Murtha AP, Madianos PN, Champagne CM, et al. Maternal periodontitis and prematurity. Part I: Obstetric outcome of prematurity and growth restriction. Ann Periodontol 2001;6(1):164-74. 6. Prevention of pre-term birth by treatment of periodontal disease. NCT00133926. Available at: http://clinicaltrials.gov/ct2/show/ NCT00133926. Accessed December 5, 2008. 7. MOTOR: Maternal oral therapy to reduce obstetric risk. NCT00097656. Available at: http://clinicaltrials.gov/ct2/show/ NCT00097656. Accessed December 5, 2008. 8. Periodontal infection and prematurity study. NCT00116974. Available at: http://clinicaltrials.gov/ct2/show/NCT00116974. Accessed December 5, 2008.
REVIEWER Martha E. Nunn, DDS, PhD Director, Biometry Core, Northeast Center for Research to Evaluate and Eliminate Dental Disparities (CREEDD), Associate Professor, Health Policy and Health Services Research, Goldman School of Dental Medicine, Boston University, 715 Albany, 560, Boston, MA 02118 [email protected]
June 2009