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Clinical Trials/NCT06110143
NCT06110143RecruitingNot Applicable

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

University Hospital Bispebjerg and Frederiksberg6 sites in 1 country600 target enrollmentStarted: November 13, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
600
Locations
6
Primary Endpoint
Increased risk markers for preeclampsia

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 48 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Increased risk markers for preeclampsia

Time Frame: 18 months

Defined as hypertension and proteinuria

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

Prevalence of gestational diabetes

Time Frame: 18 months

Defined as glucose intolerance

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karoline Winckler

Phd, postdoc

University Hospital Bispebjerg and Frederiksberg

Study Sites (6)

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