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New treatment option for Pregnancy
Official title Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
ClinicalTrials.gov ID: NCT07069140
What this study is testing
What is Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)?
Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pregnancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This randomized controlled clinical trial aims to evaluate the effectiveness of a lactoferrin-based oral hygiene protocol in improving periodontal health during pregnancy. Forty pregnant women between the fourth and eighth month of gestation will be enrolled and randomly assigned to one of two groups.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Pregnant women aged between 18 and 45 years
- Gestational age between 14 and 28 weeks at the time of enrollment (second trimester)
- Diagnosis of periodontitis according to the 2017 World Workshop classification (Stages I-III, Grades A-B)
- Presence of at least 20 natural teeth
- Willingness to comply with study procedures and attend follow-up visits
You likely can't join if
- History of systemic diseases that could affect periodontal status (e.g., diabetes mellitus, immunosuppression)
- Antibiotic or anti-inflammatory therapy within 3 months prior to enrollment Current use of probiotics, antioxidant supplements, or medicated...
- Periodontal treatment within 6 months before enrollment
- High-risk pregnancy or pregnancy complications (e.g., preeclampsia, gestational diabetes)
- Smoking or tobacco use
- Known allergy to any of the investigational product components
See the full eligibility criteria
- Pregnant women aged between 18 and 45 years
- Gestational age between 14 and 28 weeks at the time of enrollment (second trimester)
- Diagnosis of periodontitis according to the 2017 World Workshop classification (Stages I-III, Grades A-B)
- Presence of at least 20 natural teeth
- Willingness to comply with study procedures and attend follow-up visits
- Signed informed consent
- History of systemic diseases that could affect periodontal status (e.g., diabetes mellitus, immunosuppression)
- Antibiotic or anti-inflammatory therapy within 3 months prior to enrollment Current use of probiotics, antioxidant supplements, or medicated mouthwashes
- Periodontal treatment within 6 months before enrollment
- High-risk pregnancy or pregnancy complications (e.g., preeclampsia, gestational diabetes)
- Smoking or tobacco use
- Known allergy to any of the investigational product components
- Participation in another clinical trial within the previous 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Lombardy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Lombardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.