NCT06110143Recruiting
Oral Health and Adverse Pregnancy Complications
The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 13 Nov 2021
- Primary completion date
- Nov 2025
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- NCT number
- NCT06110143
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 13 Nov 2021 to the primary completion date, Nov 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant women with peridontitis and currently receiving treatment for peridontitis
Other
- Pregnant women without peridontitis
- Pregnant women with less than 20 healthy teeths
- Pregnant women with peridontitis stage IV
Who the study is looking for
- 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
Age in the registry: 16 years to 48 years · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Holbæk Hospital Coordinator of this site? Confirm its status | Holbæk | Denmark | Recruiting |
| Holbaek Hospital Coordinator of this site? Confirm its status | Holbæk | Denmark | Recruiting |
| Nykøbing Falster Hospital Coordinator of this site? Confirm its status | Nykøbing Falster | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.