Periodontitis and Pregnancy Clinical Trial
Official title:
Safety and Efficacy of L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 in Pregnant Women to Improve Oral Health and Reduce the Risk for Prematurity or Intrauterine Growth Retardation (IUGR)
Randomized controlled tril to evaluate the safety and efficacy for the combination of L.
reuteri ATCC PTA 5289 & L. reuteri DSM 17938 in pregnant women with periodontitis and/or
gingivits to improve oral health and at the same time reduce the risk for prematurity or
intrauterine growth retardation (IUGR).
Women in this study wil receive L. reuteri Prodentis (L. reuteri DSM 17938 & L. reuteri ATCC
PTA 5289 ) at a dose of 2x10^8 Colony Forming Units (CFU). One lozenges is to be taken twice
per day (one in the morning and one in the afternoon) giving a total daily dose of at least
4x108 CFU/day since randomization until delivery. The control group will receive placebo
lozenges which contains identical ingredients except for lacking the bacteria. One lozenges
is to be taken twice per day (one in the morning and one in the afternoon. The study product
will be kept refrigerated (+20 - +80 C)
Rationale. Gingivitis and periodontitis represent highly prevalent oral pathologies in
pregnant women. The physiological, immunological and endocrine changes imposed by pregnancy
are associated with a greater predisposition for the development of gingivitis. Considering
the potential association between the presence of gingivitis and the development of
complications during pregnancy and the time of delivery (preeclampsia, preterm, IUGRs), it is
important to evaluate the impact of early administration of a mixture of lactobacillus on
improved health oral status, and at the same time assessing the effect on risk reduction of
prematurity and/or IUGRs.
For primary outcome the investigators will evaluate the changes along the study in the oral
health status evaluated through a composite of Modified Gingival Index (Lobene) + Plaque
Index (Silnes and Loe) + Gingival Bleeding Index + Probing pocket depth (PPD) and Clinical
attachment level (CAL).
For secondary outcomes the investigators will evaluate rate of prematurity and or
Intrauterine growth retardation; changes in mother salivary markers of systemic inflammation;
profile of inflammosome in placenta and new born cord blood; lactobacilli, bifidobacteria and
streptococcus profile in vagina by RT-PCR (specific primers); changes during the study for
oral microbiome Intervention group wil receive L. reuteri Prodentis (L. reuteri DSM 17938 &
L. reuteri ATCC PTA 5289 ) at a dose of 2x10^8 Colony Forming Units (CFU). One lozenges is to
be taken twice per day (one in the morning and one in the afternoon) giving a total daily
dose of at least 4x108 CFU/day since randomization until delivery.
The control group will receive placebo lozenges which contains identical ingredients except
for lacking the bacteria. One lozenges is to be taken twice per day (one in the morning and
one in the afternoon. The study product will be kept refrigerated (+20 - +80 C)
;