Improving oral health during pregnancy to prevent complications
Official title: The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study
Run by University Hospital Bispebjerg and Frederiksberg · NCT06110143 · Data updated 2026-11-12
This study tests if treating gum disease in pregnant women can help their babies grow better and lower the chances of early delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 48 Years |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 3 sites (Holbæk, Holbaek and 2 other locations) |
| Status | Recruiting |
| Started | November 13, 2021 |
| Main results expected | November 2025 |
| Study ends | May 2026 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT06110143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women diagnosed with periodontitis who plan to give birth at Holbaek or Nykøbing Falster hospitals.
✕Probably not a fit
Patients without periodontitis or those currently receiving treatment for the condition will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of treating periodontal disease in pregnant women on fetal growth and the risk of preterm delivery. It focuses on women diagnosed with periodontitis, a common inflammatory condition that can worsen during pregnancy due to hormonal changes. The intervention involves providing periodontal treatment to improve oral health and potentially reduce adverse pregnancy outcomes. The study aims to address the gap in dental care among pregnant women, as many do not seek regular dental visits.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy outcomes and healthier births by addressing periodontal disease in pregnant women.
How similar studies have gone: Other studies have indicated a link between periodontal health and pregnancy outcomes, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Holbaek Hospital
Holbæk, Holbaek, Denmark Recruiting -
Holbæk Hospital
Holbæk, Holbaek, Denmark Recruiting -
Nykøbing Falster Hospital
Nykøbing Falster, Nykøbing Falster, Denmark Recruiting
Study contacts
- Principal investigator: Berit Lilienthal Heitmann, Professor — University Hospital Bispebjerg and Frederiksberg
- Study coordinator: Karoline Winckler, Phd
- Email: karoline.winckler@regionh.dk
- Phone: 38163016
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
-
Examining how aspirin metabolism relates to metabolic dysfunction in pregnant individuals at risk of preeclampsia
This study is trying to see how the way pregnant people process aspirin relates to their metabolic health and the health of their babies, especially for those at risk of preeclampsia.
-
ASPIRE: Predicting Pregnancy Complications Using Blood and Eye Imaging
This study tests whether blood and eye imaging biomarkers can predict conditions like preeclampsia, fetal growth restriction, and gestational diabetes in first-time pregnant people carrying one baby.
-
Aspirin with or without low‑molecular‑weight heparin to prevent preeclampsia in high‑risk pregnancy
This trial tests whether adding low‑molecular‑weight heparin (tinzaparin) to low‑dose aspirin reduces the chance of preeclampsia in pregnant people identified as high risk in the first trimester.
-
Real-time glucose monitoring with group support during pregnancy
This program will test whether wearing a real-time glucose monitor and joining a group chat helps pregnant people at risk for gestational diabetes keep their blood sugar in a healthy range.
-
Evaluating new ultrasound techniques for assessing placental health
This study is testing new ultrasound techniques to see if they can help tell the difference between healthy pregnancies and those with fetal growth issues.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.