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Recruiting NCT06110143

NCT06110143 Oral Health and Adverse Pregnancy Complications

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Clinical Trial Summary
NCT ID NCT06110143
Status Recruiting
Phase
Sponsor University Hospital Bispebjerg and Frederiksberg
Condition Periodontal Diseases
Study Type INTERVENTIONAL
Enrollment 600 participants
Start Date 2021-11-13
Primary Completion 2025-11

Eligibility & Interventions

Sex Female only
Min Age 16 Years
Max Age 48 Years
Study Type INTERVENTIONAL
Interventions
Periodontal treatment

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 600 participants in total. It began in 2021-11-13 with a primary completion date of 2025-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility 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

Contact & Investigator

Central Contact

Karoline Winckler, Phd

✉ karoline.winckler@regionh.dk

📞 38163016

Principal Investigator

Berit Lilienthal Heitmann, Professor

PRINCIPAL INVESTIGATOR

University Hospital Bispebjerg and Frederiksberg

Frequently Asked Questions

Who can join the NCT06110143 clinical trial?

This trial is open to female participants only, aged 16 Years or older, up to 48 Years, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06110143 currently recruiting?

Yes, NCT06110143 is actively recruiting participants. Contact the research team at karoline.winckler@regionh.dk for enrollment information.

Where is the NCT06110143 trial being conducted?

This trial is being conducted at Holbæk, Denmark, Holbæk, Denmark, Nykøbing Falster, Denmark.

Who is sponsoring the NCT06110143 clinical trial?

NCT06110143 is sponsored by University Hospital Bispebjerg and Frederiksberg. The principal investigator is Berit Lilienthal Heitmann, Professor at University Hospital Bispebjerg and Frederiksberg. The trial plans to enroll 600 participants.

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