Oral Health and Adverse Pregnancy Complications

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-48
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

Pregnant women are susceptible to develop periodontitis, but these oral health changes related to pregnancy are often neglected. Periodontitis is accompanied by a low-grade systemic inflammation and can be harmful to the general health of the woman, contribute to pre-term birth and adversely influence the future health and metabolism of the offspring. Despite this, studies indicate that 40% of Danish women in childbearing age do not visit a dentist regularly. The PROBE controlled intervention study will investigate the beneficial effect of treatment of periodontal disease during pregnancy on fetal growth, preterm delivery and birth weight.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women who are planned to give birth at either Holbaek or Nykoebing Falster hospital

Pregnant women diagnosed with periodontitis (stage I-III) by the study dentist

Disqualifiers

Pregnant women without peridontitis

Pregnant women with less than 20 healthy teeths

Pregnant women with peridontitis and currently receiving treatment for peridontitis

Pregnant women with peridontitis stage IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Periodontal treatment

    Other intervention

    Periodontal treatment

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: PrePROBEOther 1 intervention
Group B: PostPROBEOther 1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of preterm birth

Defined as any birth before 37 completed weeks of gestation

Time frame
18 months
2

Prevalence of low birthweight

Defined as a birth weight of less than 2500 gram

Time frame
18 months
3

Increased risk markers for preeclampsia

Defined as hypertension and proteinuria

Time frame
18 months
4

Prevalence of gestational diabetes

Defined as glucose intolerance

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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