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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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