Actively Recruiting

Phase Not Applicable
Age: 16Years - 48Years
FEMALE
Healthy Volunteers
ID06110143

The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study

Led by University Hospital Bispebjerg and Frederiksberg · Updated on 2025-03-30

600

Participants Needed

3

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study pregnant women who develop periodontitis, a common chronic gum disease that causes inflammation and can harm both oral and general health. The study investigates whether treating periodontitis during pregnancy can improve outcomes such as fetal growth, reduce the risk of preterm birth, low birth weight, and markers related to preeclampsia and gestational diabetes. The study also explores how periodontitis-related inflammation might affect the future health and metabolism of the child. The study compares two groups of pregnant women diagnosed with periodontitis: one group receiving periodontal treatment during pregnancy and another receiving the same treatment postpartum. Treatment involves up to five periodontal therapy sessions over about 20 weeks. Recruitment and treatment periods last 18 months for each group. The study collects detailed information on participants' oral health, lifestyle, and socioeconomic factors through questionnaires at various stages during and after pregnancy. Participants will attend scheduled visits for dental exams and periodontal treatment, along with completing online questionnaires about diet, smoking, physical activity, and oral health habits at baseline, week 35 of gestation, and at two and six months postpartum. Researchers will monitor pregnancy outcomes including preterm birth, low birth weight, and risk markers for preeclampsia and gestational diabetes over 18 months. The study also includes follow-up questionnaires on infant growth and family oral health after birth.

CONDITIONS

Brief Title

Oral Health and Adverse Pregnancy Complications

Who Can Participate

Age: 16Years - 48Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnant women without periodontitis
  • Pregnant women with less than 20 healthy teeth
  • Pregnant women with periodontitis currently receiving treatment
  • Pregnant women with periodontitis stage IV

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening visit with a study dentist

Treatment

Duration - Approximately 20 weeks

Participants diagnosed with periodontitis receive up to 5 periodontal treatments either during pregnancy or after giving birth to investigate effects on pregnancy outcomes.

Up to 5 treatment visits

Monitoring

Duration - From baseline (week 11-13 of gestation) through 6 months postpartum

Participants complete online questionnaires about diet, smoking, physical activity, oral health, and baby growth at baseline, late pregnancy, and postpartum to monitor health and outcomes.

4 online questionnaire timepoints

Trial Site Locations

Total: 3 locations

1

Holbaek Hospital

Holbæk, Holbaek, Denmark, 4300

Actively Recruiting

2

Holbæk Hospital

Holbæk, Holbaek, Denmark, 4300

Actively Recruiting

3

Nykøbing Falster Hospital

Nykøbing Falster, Nykøbing Falster, Denmark, 4800

Actively Recruiting

Loading map...

Research Team

K

Karoline Winckler, Phd

K

Kathrine Bukkehave, Dentist

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in ...

Gestational Diabetes

Actively Recruiting

1 location

A Multicenter Cohort Study on Maternal and Infant Microecolo...

Preeclampsia

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper.

Karoline Winckler, Kathrine Hansen Bukkehave, Lise Tarnow...

https://pubmed.ncbi.nlm.nih.gov/38739615