Clinical trial Recruiting at 3 sites Interventional Ages 16 to 48 Women only

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.

More Periodontal Diseases trials

Quick facts

Study typeInterventional
Ages16 Years to 48 Years
SexWomen only
Enrollment600 (estimated)
SponsorUniversity Hospital Bispebjerg and Frederiksberg
Academic / other
Locations3 sites (Holbæk, Holbaek and 2 other locations)
StatusRecruiting
StartedNovember 13, 2021
Main results expectedNovember 2025
Study endsMay 2026
Registry record updatedMarch 30, 2025
Trial IDNCT06110143 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.