Periodontal DiseasesNCT06110143
Oral Health and Adverse Pregnancy Complications
A study testing Periodontal treatment in people with Periodontal Diseases and Pregnancy Complications, run by University Hospital Bispebjerg and Frederiksberg at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Pregnancy Complications, Pregnancy Preterm
- What is being tested?
- Periodontal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 Nov 2021to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Holbaek Hospital
Holbæk, Holbaek, 4300
Heidi Fischer, Midwife, 59484320, hefi@regionsjaelland.dk
Signe Dueholm, Midwife, 59484320, scdu@regionsjaelland.dk
- Recruiting
Holbæk Hospital
Holbæk, Holbaek, 4300
Heidi Fischer, Midwife, 59 48 42 54, hefi@regionsjaelland.dk
Signe Dueholm, Midwife, 59484320, scdu@regionsjaelland.dk
- Recruiting
Nykøbing Falster Hospital
Nykøbing Falster, Nykøbing Falster, 4800
Pia Jensen, Secretary, 56515412, pij@regionsjaelland.dk
Anette Jensen, Secretary, 56515400, asj@regionsjaelland.dk
About this study
Official title: The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study
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.
Read the detailed description
Periodontitis is one of the most common and chronic inflammatory oral conditions reaching approximately 20 - 60 % of the global population. The disease is characterized as a set of inflammatory conditions affecting the tissues surrounding the teeth. In the early stages, called gingivitis, where the disease is still reversible, the gums can become swollen, red and may bleed. Later in the disease development, periodontitis will progress into a more chronic condition. If untreated, periodontitis can cause tooth loss resulting in several complications including impaired speech, low self-esteem and reduced ability to eat freely and accumulating evidence has now linked periodontitis to a wide range of common medical conditions.
Pregnant women are susceptible to develop periodontitis due to hormonal changes leading to increased blood flow, plaque retention and risk of gingival infection, that may progress to periodontitis if persisting untreated. The prevalence of periodontitis in pregnancy has not been systematically assessed and varies significantly across studies with a range of 0 % -61 %. This large variation might be attributed to the diverse definitions of periodontitis. Still, optimal oral health care during pregnancy is often neglected and numbers from the Danish Dental Association indicate that 40% of Danish women in childbearing age do not visit a dentist regularly. Apart from the oral consequences resulting from periodontitis the condition is accompanied by a low-grade systemic inflammation. The systemic inflammation caused by periodontitis during pregnancy may have consequences beyond the oral cavity. Systematic reviews have shown that women with periodontitis can adversely influence the future health and metabolism of the offspring by an increased risk of preterm birth (< 37 weeks gestation) and delivering babies with low-birth-weight (< 2.5 kg). However, the biological mechanism underlying the link between periodontitis and adverse pregnancy outcomes is not fully known.
Early prevention of periodontal disease among pregnant women may have beneficial effects for both the mother and child. Providing periodontal treatment for pregnant women might reduce the risk of preterm birth, low birthweight as well as risk markers for pre-eclampsia and gestational disease. The idea and ambition of the prevention of adverse pregnancy outcomes by periodontal treatment' (PROBE) controlled intervention study is to investigate the beneficial effect of treatment of periodontal disease during pregnancy on fetal growth, preterm delivery and birth weight. Firstly, by investigating the prevalence of periodontitis among pregnant women. Secondly to prevent development of periodontal disease and the related systemic inflammation during pregnancy by intervening with periodontal treatment to reduce the risk of pregnancy and birth related outcomes. Reducing the development of these outcomes are expected to limit the risk of later development of metabolic disturbances in the offspring. Another implication of minimizing the prevalence of periodontitis is the potential reduction in other chronic diseases that periodontitis has been linked to, e.g. diabetes, cardiovascular disease and Alzheimer's.
If the key findings from the PROBE study are positive, the main message will be that oral hygiene and prevention of periodontitis during pregnancy are important and that treatment and regular visits to a dentist needs priority during pregnancy. Offering free dental care during pregnancy in Denmark would in the already established clinics be an easy implementable strategy to reduce adverse pregnancy and birth related outcomes. There will be economic costs related to providing free dental care, but the long-term beneficial effects both for the women and children as well as for society are expected to be significant and may exceed the costs of the intervention.
The overall aims of the study are to:
- Investigate the prevalence of periodontitis in pregnant women and whether periodontal treatment during pregnancy can improve the periodontal condition (less pocket depth, bleeding on probing and attachment loss) and reduce the systemic inflammation.
- Investigate whether periodontal treatment contributes to a reduced risk of preterm birth, low birthweight and lower risk markers of preeclampsia and gestational diabetes (blood pressure and hemoglobin A1c (HbA1c)).
The PROBE study is a controlled intervention study, where approximately 1200 pregnant women will be recruited from either Holbæk Hospital or Nykøbing Falster Hospital in Region Zealand in Denmark during their nuchal fold scan in gestation week 11-14 following a periodontal screening visit at the study dentist. During the nuchal fold scan, the secretaries will hand out documents to all pregnant women attending the scan. Inclusion criteria are pregnant women who speaks and understand Danish and is diagnosed with periodontitis by the study dentist. Exclusion criteria are pregnant women without periodontitis. The secretaries at Holbæk and Nykøbing Falster Hospitals will coordinate the recruitment and inclusion of participants for the study. Information on eligible participants will be given to the research coordinator and the research dentist by the secretaries. It is expected that 50 % of the screened population will be diagnosed with periodontitis and suitable for inclusion. The intervention group of approximately 300 pregnant women with periodontitis, receives periodontal treatment during pregnancy, and the control group of approximately 300 pregnant women with periodontitis, receives periodontal treatment after giving birth. The method and data collection activities are the same for both the intervention and the control group, except for the time of the periodontal treatments that are performed during pregnancy and after birth. The time period for the periodontal treatments will be the same for each group, approximately 20 weeks, and each included participant can receive up to 5 periodontal treatments. Recruitment of pregnant women with periodontitis will last over a period of 18 months for the intervention group and additional 18 months for the control group.
Demographic information, qualitative questionnaires related to diet, smoking status, physical activity, family status, socio economic status and oral health care and dental habits will be collected at baseline (week 11-13 of gestation) and at week 35 of gestation through online questionnaires. Two months and six months post-partum two additional qualitative questionnairea regarding growth of the baby, and questions about the partner, oral health and dental habits will be send through online questionnaire.
Regional dental clinics in Region Zealand have been approached in relation to possibilities of providing available clinics. The clinics have responded positively and are willing to provide the clinics also outside normal opening hours, which would facilitate potential implementation of the project afterwards.
- Conditions
- Periodontal Diseases, Pregnancy Complications, Pregnancy Preterm, Gestational Diabetes, Preeclampsia, Inflammation
- Being tested
- Periodontal treatment
- Medical subject headings
- Periodontal Diseases, Pregnancy Complications, Diabetes, Gestational, Pre-Eclampsia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentOther
Periodontal treatment
| Study group | Role | What they receive |
|---|---|---|
| PrePROBE | Other | Periodontal treament during pregnancy Receives: Other: Periodontal treatment |
| PostPROBE | Other | Peridontal treatment postpartum Receives: Other: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of preterm birth
Defined as any birth before 37 completed weeks of gestation
Measured: 18 months
Prevalence of low birthweight
Defined as a birth weight of less than 2500 gram
Measured: 18 months
Increased risk markers for preeclampsia
Defined as hypertension and proteinuria
Measured: 18 months
Prevalence of gestational diabetes
Defined as glucose intolerance
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start13 Nov 2021
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karoline Winckler, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Berit Lilienthal Heitmann, Professor, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110143
- Sponsor's protocol ID
- H-20083249
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38739615
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study
- ClinicalTrials.gov ID
- NCT06110143
- Acronym / sponsor ID
- H-20083249
- Conditions
- Periodontal Diseases, Pregnancy Complications, Pregnancy Preterm, Gestational Diabetes, Preeclampsia, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Periodontitis is one of the most common and chronic inflammatory oral conditions reaching approximately 20 - 60 % of the global population. The disease is characterized as a set of inflammatory conditions affecting the tissues surrounding the teeth. In the early stages, called gingivitis, where the disease is still reversible, the gums can become swollen, red and may bleed. Later in the disease development, periodontitis will progress into a more chronic condition. If untreated, periodontitis can cause tooth loss resulting in several complications including impaired speech, low self-esteem and reduced ability to eat freely and accumulating evidence has now linked periodontitis to a wide range of common medical conditions.
Pregnant women are susceptible to develop periodontitis due to hormonal changes leading to increased blood flow, plaque retention and risk of gingival infection, that may progress to periodontitis if persisting untreated. The prevalence of periodontitis in pregnancy has not been systematically assessed and varies significantly across studies with a range of 0 % -61 %. This large variation might be attributed to the diverse definitions of periodontitis. Still, optimal oral health care during pregnancy is often neglected and numbers from the Danish Dental Association indicate that 40% of Danish women in childbearing age do not visit a dentist regularly. Apart from the oral consequences resulting from periodontitis the condition is accompanied by a low-grade systemic inflammation. The systemic inflammation caused by periodontitis during pregnancy may have consequences beyond the oral cavity. Systematic reviews have shown that women with periodontitis can adversely influence the future health and metabolism of the offspring by an increased risk of preterm birth (< 37 weeks gestation) and delivering babies with low-birth-weight (< 2.5 kg). However, the biological mechanism underlying the link between periodontitis and adverse pregnancy outcomes is not fully known.
Early prevention of periodontal disease among pregnant women may have beneficial effects for both the mother and child. Providing periodontal treatment for pregnant women might reduce the risk of preterm birth, low birthweight as well as risk markers for pre-eclampsia and gestational disease. The idea and ambition of the prevention of adverse pregnancy outcomes by periodontal treatment' (PROBE) controlled intervention study is to investigate the beneficial effect of treatment of periodontal disease during pregnancy on fetal growth, preterm delivery and birth weight. Firstly, by investigating the prevalence of periodontitis among pregnant women. Secondly to prevent development of periodontal disease and the related systemic inflammation during pregnancy by intervening with periodontal treatment to reduce the risk of pregnancy and birth related outcomes. Reducing the development of these outcomes are expected to limit the risk of later development of metabolic disturbances in the offspring. Another implication of minimizing the prevalence of periodontitis is the potential reduction in other chronic diseases that periodontitis has been linked to, e.g. diabetes, cardiovascular disease and Alzheimer's.
If the key findings from the PROBE study are positive, the main message will be that oral hygiene and prevention of periodontitis during pregnancy are important and that treatment and regular visits to a dentist needs priority during pregnancy. Offering free dental care during pregnancy in Denmark would in the already established clinics be an easy implementable strategy to reduce adverse pregnancy and birth related outcomes. There will be economic costs related to providing free dental care, but the long-term beneficial effects both for the women and children as well as for society are expected to be significant and may exceed the costs of the intervention.
The overall aims of the study are to:
- Investigate the prevalence of periodontitis in pregnant women and whether periodontal treatment during pregnancy can improve the periodontal condition (less pocket depth, bleeding on probing and attachment loss) and reduce the systemic inflammation.
- Investigate whether periodontal treatment contributes to a reduced risk of preterm birth, low birthweight and lower risk markers of preeclampsia and gestational diabetes (blood pressure and hemoglobin A1c (HbA1c)).
The PROBE study is a controlled intervention study, where approximately 1200 pregnant women will be recruited from either Holbæk Hospital or Nykøbing Falster Hospital in Region Zealand in Denmark during their nuchal fold scan in gestation week 11-14 following a periodontal screening visit at the study dentist. During the nuchal fold scan, the secretaries will hand out documents to all pregnant women attending the scan. Inclusion criteria are pregnant women who speaks and understand Danish and is diagnosed with periodontitis by the study dentist. Exclusion criteria are pregnant women without periodontitis. The secretaries at Holbæk and Nykøbing Falster Hospitals will coordinate the recruitment and inclusion of participants for the study. Information on eligible participants will be given to the research coordinator and the research dentist by the secretaries. It is expected that 50 % of the screened population will be diagnosed with periodontitis and suitable for inclusion. The intervention group of approximately 300 pregnant women with periodontitis, receives periodontal treatment during pregnancy, and the control group of approximately 300 pregnant women with periodontitis, receives periodontal treatment after giving birth. The method and data collection activities are the same for both the intervention and the control group, except for the time of the periodontal treatments that are performed during pregnancy and after birth. The time period for the periodontal treatments will be the same for each group, approximately 20 weeks, and each included participant can receive up to 5 periodontal treatments. Recruitment of pregnant women with periodontitis will last over a period of 18 months for the intervention group and additional 18 months for the control group.
Demographic information, qualitative questionnaires related to diet, smoking status, physical activity, family status, socio economic status and oral health care and dental habits will be collected at baseline (week 11-13 of gestation) and at week 35 of gestation through online questionnaires. Two months and six months post-partum two additional qualitative questionnairea regarding growth of the baby, and questions about the partner, oral health and dental habits will be send through online questionnaire.
Regional dental clinics in Region Zealand have been approached in relation to possibilities of providing available clinics. The clinics have responded positively and are willing to provide the clinics also outside normal opening hours, which would facilitate potential implementation of the project afterwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrePROBE | Other | Other: Periodontal treatmentPeriodontal treament during pregnancy |
| PostPROBE | Other | Other: Periodontal treatmentPeridontal treatment postpartum |
Who may qualify
- Ages
- 16 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal treatmentPeriodontal treatment | Other | PostPROBE, PrePROBE |
Primary outcome
Prevalence of preterm birth
Time frame: 18 months
Defined as any birth before 37 completed weeks of gestation
Prevalence of low birthweight
Time frame: 18 months
Defined as a birth weight of less than 2500 gram
Increased risk markers for preeclampsia
Time frame: 18 months
Defined as hypertension and proteinuria
Prevalence of gestational diabetes
Time frame: 18 months
Defined as glucose intolerance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 38739615Winckler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berit Lilienthal Heitmann, Professor principal investigator
University Hospital Bispebjerg and Frederiksberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Periodontal Diseases and Pregnancy Complications, run by University Hospital Bispebjerg and Frederiksberg at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karoline Winckler, Phd (38163016, karoline.winckler@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of preterm birth (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.