Results from the double-blind randomised controlled trial, published in the Journal of Clinical Periodontology, showed pregnant women taking BioGaia’s ProDentis lozenges containing the probiotic L. reuteri had significantly lower gingivitis levels, compared to those taking a placebo.
Researchers from the University Hospital Wuerzburg supplied 45 women in Germany, aged between 24 and 40, generally in good health and with uncomplicated pregnancies with lozenges from week 28 of pregnancy until birth – around seven weeks from the start of the study.
Twenty-four subjects received lozenges containing at least 108 colony-forming units of two different Lactobacillus reuteri strains, while 21 subjects received placebo lozenges.
Probiotic supplier BioGaia provided both the test and placebo lozenges for free, but did not provide any other funding for the study.
Hormone changes during pregnancy can increase the risk of developing gingivitis, with up to half of all pregnant women suffering from the gum condition.
The subjects received a supply of lozenges sufficient for 112 days, with instructions to take two a day. They were told to let them dissolve slowly in the mouth, but were given no other instruction regarding oral health beyond maintaining their existing regimes.
All participants gave birth within 50 days of starting the trial, and a review of unused lozenges showed they had taken around 2.5 lozenges a day on average.
Baseline measurements showed all subjects had similar gingivitis levels. Yet at the end of the study, test subjects showed gingivial index (GI) scores of around a fifth compared to the start, while the placebo group showed only a slight fall.
“The pattern of GI scores recorded at the end of the study clearly demonstrate that particularly in the L. reuteri group not only sites with mild gingivitis resolved but also the percentage of sites exhibiting GI categories 2 and 3 [more severe gingivitis] pronouncedly decreased. It also has to be noted that these changes occurred without any intentional interference with personal oral hygiene or the performance of professional mechanical plaque removal,” wrote the study’s authors in their conclusion.
‘A good first study’
Axel Sjöblad, managing director of BioGaia, said the study opened up new fields for the firm.
“Right now this is a good start for us, because this gives us the opportunity to enter a new area – we have not directly worked towards pregnant women before. We are starting with this, and this is a good first study for us.
“Our success is really built on working with child health and colic first of all, and then from that we have developed our portfolio. We have one portfolio that is addressing adults, and one for oral health. This now helps us go one step back in the chain, and also start addressing the pregnant mother – it’s a good way for BioGaia to broaden its offering for the future,” he added.
The pregnancy probiotic market has been getting more attention in recent months, with both Nestlé and Biosearch Life pursuing products aimed at pregnant women or women trying to conceive.
But Sjöblad said BioGaia would not be pursuing a health claim without more evidence.
“The way we work is we’d like to do some more studies, before we really move full steam ahead. But this is a good start, a good introduction, and we were very happy when these results were published from Germany.”
Asked if the new gingivitis study would result in new products, Sjöblad said: “Right now we will continue with ProDentis that we already have, that is used for oral health.
"That is the product we have right now. When will the portfolio be broadened – that is a little too early to say. We have a lot of products in the pipeline, but we can talk about them more when we’re getting closer to launch.”
Source: Journal of Clinical Periodontology
Published online ahead of print, doi: 10.1111/jcpe.12606
“Regular consumption of Lactobacillus reuteri-containing lozenges reduces pregnancy gingivitis: an RCT”
Authors: Schlagenhauf, U.; Jakob, L.; Eigenthaler, M.; Segerer, S.; Jockel-Schneider, Y.; Rehn, M.