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Recruiting Not applicable

Oral Health and Adverse Pregnancy Complications

NCT06110143 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2021-11-13
Last updated
2025-03-30

Condition(s) studied

Periodontal DiseasesPregnancy ComplicationsPregnancy PretermGestational DiabetesPreeclampsiaInflammation

Investigational drug(s) / intervention(s)

Periodontal treatment

Periodontal treatment: Periodontal treatment

Study summary

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

Sex
FEMALE
Min age
16 Years
Max age
48 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Prevalence of preterm birth — 18 months
    Defined as any birth before 37 completed weeks of gestation
  • Prevalence of low birthweight — 18 months
    Defined as a birth weight of less than 2500 gram
  • Increased risk markers for preeclampsia — 18 months
    Defined as hypertension and proteinuria
  • Prevalence of gestational diabetes — 18 months
    Defined as glucose intolerance

Trial sites (3)

FacilityCityRegionStatus
Holbaek Hospital Holbæk Holbaek Recruiting
Holbæk Hospital Holbæk Holbaek Recruiting
Nykøbing Falster Hospital Nykøbing Falster Nykøbing Falster Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06110143 on ClinicalTrials.gov ↗ ← All trials in Denmark