NCT06110143

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

October 25, 2023

Last Update Submit

March 25, 2025

Conditions

Periodontal DiseasesPregnancy ComplicationsPregnancy PretermGestational DiabetesPreeclampsiaInflammation

Outcome Measures

Primary Outcomes (4)

  • Prevalence of preterm birth

    Defined as any birth before 37 completed weeks of gestation

    18 months

  • Prevalence of low birthweight

    Defined as a birth weight of less than 2500 gram

    18 months

  • Increased risk markers for preeclampsia

    Defined as hypertension and proteinuria

    18 months

  • Prevalence of gestational diabetes

    Defined as glucose intolerance

    18 months

Study Arms (2)

PrePROBE

OTHER

Periodontal treament during pregnancy

Other: Periodontal treatment

PostPROBE

OTHER

Peridontal treatment postpartum

Other: Periodontal treatment

Interventions

Periodontal treatmentOTHER

Periodontal treatment

PostPROBEPrePROBE

Eligibility Criteria

Age16 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Holbaek Hospital

Holbæk, Holbaek, 4300, Denmark

RECRUITING

Holbæk Hospital

Holbæk, Holbaek, 4300, Denmark

RECRUITING

Nykøbing Falster Hospital

Nykøbing Falster, Nykøbing Falster, 4800, Denmark

RECRUITING

Related Publications (1)

  • Winckler K, Bukkehave KH, Tarnow L, Iversen PB, Damgaard C, Ditlev SB, Kofoed-Enevoldsen A, Fischer HM, Dueholm SCH, Lauenborg J, Trier C, Heitmann BL. The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper. PLoS One. 2024 May 13;19(5):e0302010. doi: 10.1371/journal.pone.0302010. eCollection 2024.

    PMID: 38739615DERIVED

MeSH Terms

Conditions

Periodontal DiseasesPregnancy ComplicationsDiabetes, GestationalPre-EclampsiaInflammation

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertension, Pregnancy-InducedPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Berit Lilienthal Heitmann, Professor

    University Hospital Bispebjerg and Frederiksberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karoline Winckler, Phd

CONTACT

38163016karoline.winckler@regionh.dk

Kathrine Bukkehave, Dentist

CONTACT

5155 9181kathrine.hansen.bukkehave@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, postdoc

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

November 13, 2021

Primary Completion

November 1, 2025

Study Completion

May 1, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)