Improving oral health during pregnancy to prevent complications
The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study
NA · University Hospital Bispebjerg and Frederiksberg · NCT06110143
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 16 Years to 48 Years |
| Sex | Female |
| Sponsor | University Hospital Bispebjerg and Frederiksberg (other) |
| Locations | 3 sites (Holbæk, Holbaek and 2 other locations) |
| Trial ID | NCT06110143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women diagnosed with periodontitis who plan to give birth at Holbaek or Nykøbing Falster hospitals.
Not a fit: Patients without periodontitis or those currently receiving treatment for the condition will not benefit from this study.
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 performed: Other studies have indicated a link between periodontal health and pregnancy outcomes, suggesting that this approach may yield beneficial results.
Eligibility criteria
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 this trial is running
Holbæk, Holbaek and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontal Diseases, Pregnancy Complications, Pregnancy Preterm, Gestational Diabetes, Preeclampsia, Inflammation