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pre-term labour and periodontitis

From: Maria Perno Goldie, RDH, MS To: Perio Therapist Group Sent: Tuesday, March 14, 2006 1:24 AM Subject: [periotherapist] Preterm births, perio linked in UNC study Preterm births, perio linked in UNC study Posted 03/07/2006 By Jennifer Garvin New York Some adverse pregnancy results can now be directly linked to periodontal disease. A new study shows that 28.6 percent of women with moderate-to-severe periodontal disease had preterm births (less than 37 weeks) compared to only 11.2 percent of women with healthy gums. "Our findings indicate that periodontal disease progression during pregnancy contributes to preterm deliveries and especially very preterm deliveries (less than 32 weeks) which places the baby at high risk for neonatal problems and disability," said Dr. Steven Offenbacher, a distinguished professor at the University of North Carolina School of Dentistry who also directs the UNC Center for Oral and Systemic Diseases. Dr. Offenbacher was a featured speaker at the ADA and American Medical Association's media briefing, "Oral and Systemic Health: Exploring the Connection," held Feb. 23. Working with a grant from the National Institute of Dental and Craniofacial Research, Dr. Offenbacher is currently conducting multi-centered trials to see if intervention by maternal gum treatment during pregnancy reduces the risk for prematurity and other periodontal disease-related complications. Dr. Offenbacher and his team of researchers recently monitored the dental health of 1,020 pregnant women, who over the course of their pregnancy and after delivery were given comprehensive periodontal exams. The first exams were performed at about 15 weeks, where 58 percent had mild gum problems and 14 percent had moderate-to-severe periodontal disease, he said. Of the women with moderate-to-severe disease, more than a quarter (28.6 percent) had a preterm birth. "Furthermore, women who had progressing periodontal infection over the course of their pregnancy were nearly 2.5 times more likely to have a very preterm birth compared with women whose infection did not change," Dr. Offenbacher said. "Periodontal progression was a significant risk factor for very preterm deliveries, even after controlling for many traditional risk factors such as race, smoking, other infections and social domain factors. "Good oral hygiene and regular dental office visits can help in treatment and prevention of periodontal disease," he said. "These results are exciting because periodontal disease represents a new risk factor we may be able to control. If periodontal care is included in the prenatal care of women planning to get pregnant and those who are already pregnant, we know we can safely treat and improve oral health. Studies are now under way to determine whether treating gum disease can also reduce the number of preterm low birth weight deliveries each year and avoid the associated complications." "This research has some significant implications for dentistry," said Dr. Daniel M. Meyer, associate executive director, ADA Division of Science. "This adds to the growing body of knowledge and evidence that oral health and general health are closely related. The key to this in the future will be new studies to assess how and when dentists should treat patients afflicted with periodontal diseases to minimize the risks associated with bacterial infections and inflammation. Ultimately, dentists in the future may have more prominent roles in general health care teams to help improve not only the health of the mother but her newborn child as well." - Maria Perno Goldie, RDH, MS As I've tried to explain... repeatedly... NIDCR has a "horse in this race" -- and they have chosen repeatedly to risk making an error towards a false negative bias (ie., towards taking the risk that there are no links) rather than agreeing with those of us who are more comfortable risking error towards the false positive (ie., we'll act like there is a link until proven otherwise). NIDCR has an institutional bias (hey we need more money for more research!) to "not get out in front of what the science says" regardless of the clinical implications of this stance. As I've explained, so does the CDC for similar reasons. However, if they are wrong, many folks will suffer the serious systemic and sometimes life-changing "costs" of their error. If we (on my side) are wrong, many more folks will suffer the "costs" of having dental work performed that they need anyhow. This is where we are. Please don't use comments from someone at the NIDCR as the gold standard reference for what is truth -- when truth is not yet known. Instead, if you want to focus-in on what may well be quackery, look a little closer to some of the other shilling I see on this site for the occasional products whose "science" is no more than a collection of anecdotes. - Mike Rethman Mike, I don't see the process of searching for the truth as disappointing. There is a contradiction occuring here: on the one hand, we have the NIDCR saying that there is no correlation between perio care and prebirth weight babies and then we have UNC dental school study (funded by NIDCR) talking about evidence of a connection. All I want to do is ask NIDCR about this contradiction. . . . it seems a bit odd to me. Am I alone in this thinking? Maybe I'm missing something. . . . . . Lynne Mike comments: To explain once again: The "truth" isn't known now and can't be known by you (or me) at this point. What's disappointing is: 1) you think it's NOW available if you search hard enough, or 2) you think that the NIDCR is more likely to provide you with an approximation of what's true (but is, as of now, unknown) than others who are just as qualified scientifically and who are less restrained politically than the NIDCR is and must be (see below). Basic landscape: NIDCR has its angle on what's known for the reasons I've discussed several times. Their angle is based, to some degree, on issues that are political/economic The link's proponents have their angle that may be arguably based, to some degree, on issues that are political/economic. What's left for dental professionals to figure out what to do clinically NOW in light of the limitations of what's known NOW. I've suggested that making clinical decisions now, based on the assumption that the link is real, makes more sense than making decisions based on the converse. This argument is based on a comparison of the costs ($$, morbidity, mortaility) of being wrong on either side of this question. That's all there is for now. Getting more opinions from whoever your contact at NIDCR is just adds to confusion on your site. Here's what they said last summer: "So to conclude, we can't tell people that periodontal disease causes preterm birth or heart disease, or results in difficulty controlling blood sugar levels or causes respiratory infections. Nor can we say that preventing or treating periodontal disease will help you avoid these conditions? That’s right. At this time, we can’t say whether or not periodontal disease causes any of these conditions or whether treating periodontal disease will prevent them. But we can tell people to treat periodontal disease for its own sake -- to avoid tooth loss and to maintain oral comfort and function." Please note that there is no "contradiction" as you wrote. The NIDCR is NOT saying that there is no correlation, rather they are extremely cautious re: causality. (There is a difference between these two terms despite how misappropriately the term "correlation" is often used or understood.) Others who see the same (mostly undisputed) correlation are concluding that in the absense of a clearly demonstrated causal relationship and/or a clearly demonstrated benefit to intervention, that intervention makes sense in the interim until we know more. If you want to discuss those papers who have disputed the correlative relationship, generally based on data-mined "research", call me and I'd be happy to discuss privately. Please understand the the NIDCR is, as much as anything, political. I'm not faulting it for that. Years of tasking NIDCR (as part of the NIH) with often silly responsibiities, beyond their ability to much affect (such as those that relate to health disparaties, affirmative action, K1-12 education, etc.) coupled with the never-ending wacko assualt on fluoridated water makes NIDCR extremely wary of saying anything definitive that has even a small possiblity of turning out to be wrong -- on anything! Such an aversion to being publically beat-up is common in government... but the NIH is among those agencies most likely to "be led out and shot" when wrong on anything. CDC is one of these as well. Add the "NIH syndrome" (sarcastically called by many the "Not Invented Here" Syndrome) and the fact that the AAP has pushed -- and has been politely ignored -- the NIDCR to do more perio-systemic outcomes research for many years... and their caution makes perfect political sense. I could go on and list lots of examples to support these observations, but I won't. Remember, I was there and I have no axe to grind at this point in my career except for tying to help my clinical colleagues cut thru the political/economic sophistry. And never forget that In government, kudos for success are rare; press lynchings for being wrong are common. I don't blame the people in the system, just a system that is imperfect as are all that are human. I spent most of my life in gov't, I know. Now you do too. Keep these thoughts in mind next time you see anyone in public life getting beat up for trying to do something more than keep his or her butt covered. the following text email was sent by me to the ADA News on March 14: Dear Sirs: I have some legitimate concerns about the recent ADA News (March 6, 2006; volume 37, No. 5) reporting the results of a recent study of the linkage between preterm births and periodontal disease on page 12. This study was announced during a large media conference but no where was there any indication that this study had been peer- reviewed or was soon to be published. This is interesting because dated February 16, 2006, in the 'Science News in Brief' from the NIDCR website (www.nidcr.nih.gov) was the press release of another research study that had been published and peer-reviewed in the European Journal of Oral Sciences. The study titled, "Cessation of Periodontal Care during pregnancy: Effect on infant birthweight" was funded by NIDCR/NIH and would have been worthy of note by the ADA News but had not been published. However, to this date there is no information on the UNC study involving preterm births v. perio on that NIDCR/NIH website. I am concerned that there has been some bias in who gets the media attention. We should hesitate to publish or draw conclusions from studies that are still ongoing and avoid less of a media hooplah for those who have been through the peer-review process. While the ADA News is a current events publication, I am disturbed by the trend of gaining media attention in this profession to push one's agenda to the detriment of good peer-reviewed science. - Frank Varon, DDS From: "Lynne H. Slim" To: periotherapist group Subject: [periotherapist] Preterm labour and periodontitis Date: Sun, 11 Jun 2006 20:13:54 -0400 Journal Of Clinical Periodontology Volume 33 Page 177 - March 2006 doi:10.1111/j.1600-051X.2006.00899.x Volume 33 Issue 3 Is pre-term labour associated with periodontitis in a Danish maternity ward? T. Skuldbøl1,2, K. H. Johansen3, G. Dahlén4, K. Stoltze1 and P. Holmstrup1 Skuldbøl T, Johansen KH, Dahlén G, Stoltze K, Holmstrup P. Is pre-term labour associated with periodontitis in a Danish maternity ward?. J Clin Periodontal 2006; 33: 177­183. doi: 10.1111/j.1600-051X.2006.00899.x. © Blackwell Munksgaard 2006. Abstract Objectives: To reveal differences in periodontal status and presence of subgingival bacteria in a Scandinavian population of women with pre-term birth compared with women who delivered at term. Materials and Methods: Twenty-one women with pre-term labour (before week 35) and 33 women with term labour (between weeks 38 and 41) were included in this case­control study. Periodontal measurements included plaque index (PlI), probing pocket depth (PPD) and bleeding on probing (BOP). Inter-proximal distances from the cemento-enamel junction (CEJ) to the marginal bone crest (MBC) were measured on bitewing radiographs. In 31 patients (16 cases and 15 controls) the subgingival plaque was analysed using "checkerboard" DNA­DNA hybridization. Results: Differences between the two examined groups were found related to "Twin births" (p=0.0064) and "Smokers" (p=0.03). None of the periodontal measurements showed any association. Significant differences were found concerning presence of Tannerella forsythensis, Treponema denticola, Peptostreptococcus micros, Streptococcus intermedius, Streptococcus oralis, Streptococcus sanguis and Capnocytophaga ochracea but when defining sites with >105 bacteria as heavily colonized, no statistical difference was found between the two groups. Conclusion: A relation between pre-term birth and periodontitis was not revealed in the present study. Like most such papers, these results have little clinical or epidemiological meaning. As I've noted here repeatedly, a failure to detect show a significant difference is not the same thing as statistical equality. That makes the results of a study such as this of little value if the conclusion that the authors hope to make is the same as the null hypothesis (eg, no differences). It appears inadequately powered. - Mike Rethman Agreed; however, remember, too, that the preterm correlation w/ periodontitis is still only that: a correlation and periodontitis may not end up being a risk factor for preterm birth. This is important information, too, and I am concerned that everyone is jumping the gun w/ these correlations and I believe it is too premature to do so. I think it's OK to say to a patient something like: untreated periodontitis may be one of many risk factors for certain systemic diseases like diabetes and CVD but we don't have all of the facts yet. - Lynne H. Slim Mike comments: The relationship of periodontitis to preterm birth is indeed, as Lynne suggests, mostly correlative, with limited prospective invervention data now in print. However, that that has been printed suggests that intervention improves pregnancy outcomes. However, I openly admit that until one or more well-designed prospective study appears in print, the question remains largely open. [But regarding additional data-mined (post hoc analyses) studies on this topic, at this point these are a waste of time and these "handwaver" studies, pro or con, should no longer be published or cited insofar as the question has moved past the handwaver stage. Indeed, writing, publishing, citing etc. such papers at this juncture is strong evidence that the folks in this chain don't understand how statistics-based science needs to be done so as to protect that basic assumptions underlying the probability tests used therein.] That said, now let's look at Lynne's implication that acting on the perio-systemic link is somehow "premature." Each of the following scenarios outline the costs v. benefits of being wrong on either side of this question. 1. False negatives: Assume there is a link and we don't act on it before it's well-demonstrated by good science. This means that a lot of preterm babies will be born who had intervention been performed, would not have been pre-term. Result: people will incur the high (you could look it up!) personal, societal and financial costs associated with many of these kids' preterm births. Of course, some will "benefit" from not having to get dental that they needed anyhow. 2. False positives: Assume there is no link and we act on a link that isn't real. Result: A whole bunch of folks become aware that pregnant women "need" to get their oral health under control. Some get it done, some don't. All suffered "unnecessary" angst about their oral health, but those who got care got care that they needed anyhow. Comparing the personal, societal and financial costs associted with being wrong on either side of this question, the appropriate answer for society seems a slam dunk to me... namely take the risk of being wrong on the side of acting as if there is a link rather than acting as if there is not (eg. "not enough evidence"). So, acting on these recommendations at this time is not "premature" as Lynne suggests -- unless one looks at the costs of possible false negatives as being equal to or less than the total costs of possible false positives. Similar decisions are made all the time based on similar cost-benefit analyses. Folks who decry such decisions on the basis "well, things aren't proven yet" aren't seeing that we make decisions all the time using limited data. Fuzzy logic is needed in most of life's endeavors, otherwise we be crippled if we waited for a path to be "proven" before taking it sans any sort of risk-benefit analysis. For example, "we don't have all the facts yet" regarding smoking and heart disease, etc., but in light of the relative (but unproven) benefits of smoking compared with the relative (but unproven) benefits of not smoking, most of us have no trouble offering up strong clinical opinions on smoking. In light of the cost-benefit analysis sketched-out above, similar strong clinical opinions are appropriate regarding pregnancy and periodontitis... until (if) good prospective data come available that suggest otherwise. (And, I repeat: a newly published paper that reports another data-mined result simply ain't it!) In closing, the perio-systemic link is probably not a huge effect, on average... but for those individuals that it does effect, the difference in your intervention may be enormous. But you will never know who you helped because a problem prevented is a problem probably undetected -- and unappreciated. So warn pregnant women. If we turn out to be wrong we'll apologize. If we don't warn them and it turns out we should have done so, I believe you should feel pretty darn bad about it in light of what you know about it right now... Mike Rethman Lynne wrote: "...remember, too, that the preterm correlation w/ periodontitis is still only that: a correlation and periodontitis may not end up being a risk factor for preterm birth. This is important information, too, and I am concerned that everyone is jumping the gun w/ these correlations and I believe it is too premature to do so. I think it's OK to say to a patient something like: untreated periodontitis may be one of many risk factors for certain systemic diseases like diabetes and CVD but we don't have all of the facts yet." Mike, I did not say imply anything with my statement and I did say that I think the responsible thing to do right now is to tell patients that untreated perio may be one of many risk factors for several systemic diseases like etc. etc. I have talked to several researchers about this and they all feel that this is a reasonable statement to make at this point. Yes, of course we want to do anything to get patients to reduce the microbial load they are carrying around but it is not a good idea to overstep our bounds and talk about cause and effect. Remember how Merck enjoyed promoting Vioxx and ignored the studies that pointed to dangers with the drug? Lynne P.S. That's why the Feds are upset, too, about all the premature flag waving about the preterm birth connection. Re: Lynne's post below. We apparently disagree on what you mean by "jumping the gun" a term that means, in track (the sport from which this saying derives) a false start. Especially so if we "want to do anything we can" as you suggest to decrease patients' bacterial loads. If one is going to warn patients about the possiblity of periodonitis being linked to serious systemic maladies, it's not out of bounds to explain why (cause and effect) we believe this to be so. Moreover, in light of the thumbnail risk/benefit analysis I wrote out here, it's clear that it's better to error on the side of believing that there is a causal link (and there not being) v. erring on the side of not suggesting causality when there really is. Simple as that. It's not "jumping the gun." Real-life decision-making often requires the use of fuzzy logic. In light of the costs of being wrong on either side of the pregnancy link issue, it's a slam-dunk to "flag wave" in support of intervention until we get better data. I thought I explained this repeatedly here... where are those who argue the same arguments jumping the gun? (BTW, in the research lexicon "flag wave" means "hey, there MAY be something here.") Regarding NIDCR, please recall that I served there and know the players. NIDCR's (CDC's too) "caution" is laudable only if there is no downside to their being wrong and not intervening with the limted data that are available. That is not the case. NEVER, EVER forget that a major mission of every bureacuracy is self-promotion as a means to self-preservation or expansion. It's usually more important to their internal goals to not be wrong and delay needed care than it is to risk being wrong and prevent possible problems. I played parts of the same game as a fed institute director -- this is how it works... strategically, anyhow. If leadership is good at it, those who are led don't know it. More with regard to the NIDCR: We've already explored the data in the absurdly written J. of Biomedical Optics paper on the Velscope, that was subsequently blurbed on the NIDCR website. Take this as an example of the theme I'm discussing here. You may also like to know that it looks like the multicenter periodontitis-cardiovascular disease intervention study is not going to be funded by the NIDCR... comically (actually sadly) they didn't seem to understand that the hypothesized health payoff is in the same order of magnitude as is cholesterol intervention. Furthermore, NIDCR, like the rest of NIH, doesn't like congressional mandates to perform clincal research... their profound bias... PROFOUND!!! is towards basic research tempered by the occasional off-beat sort of clinical research that is cheap to do and advertises a high payoff for minimal investment. The cardiovascular study would have been very expensive (around $50 million). I suspect this is the real reason... but some honesty would be nice... sometimes money can be found elsewhere in collaborative-type efforts. Add the NIH Syndrome ("Not Invented Here") for which the NIH (National Institutes of Health) is infamous, and here we are. Plus, of course, the overdone funding of NHANES III data-mining studies and other nonsense that are known to be conducted by authors who have a demonstrated mindset going in and who are looking at topics on which ample flag-waving has already been done. Some, including me, are beginning to feel pretty strongly that the NIDCR is broken, or at least lamed. (I can't speak for the other institutes, but the pressures and games are the same across the board.) I suspected there were serious problems when I was on the Council there. Now I'm just about convinced. (Please remember that I have no horse in the race at all -- other than trying to help cut thru the B.S. on behalf of patients' health.) Vioxx is related to all this but not the way you seem to think. Certainly, it appears that Merck didn't do all it could have done to warn-off certain patients to suit its own ends... just like some of the NIDCR rent-seeking behavior I've detailed. The facts seem to be that Merck didn't include the side-effects that occurred in their study populations after the study had been completed. In light of the RIGID requirements for pivotal Phase III studies, this is understandable. A truly guity party in this game is the FDA, at least in my opinion. And once confronted with the problems with Vioxx FDA over-reacted and pulled its approval. What's the FDA's culpability? The FDA doesn't really force Phase IV studies (post-approval) as it should on blockbuster drugs like Vioxx. And, you probably would like to know that there are lots of practitioners and patients that want Vioxx back on the market. Another example of tough decisions is a new drug for MS that's in the FDA approval process whose side-effects kill one in one thousand patients... but most MS patients want it approved. So tell your patients whatever you want... although if I was your patient I'd be confused. Why? It's my opinion that patients typically appreciate professionals to be more sure of their recommendations than "it's one of many risk factors" even though that careful statement may be true. Of course, if you go with Hujoel et al's NIH-funded data-mined studies that dis oral hygiene as a risk factor for periodontitis, perhaps it's time to stop recommending better oral hygiene as a preventative. Don't wanna jump the gun, eh? - Mike Rethman
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