Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Launched by UNIVERSITY OF PAVIA · Jul 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether using a special oral care routine with products containing lactoferrin—a natural protein known to help fight bacteria—can improve gum health in pregnant women. The researchers want to see if adding a lactoferrin mouthwash to regular dental cleaning and toothpaste can reduce dental plaque and gum inflammation better than using the toothpaste alone. The study will include 40 pregnant women who are in their second trimester (between about 3.5 to 6.5 months pregnant) and who have some level of gum disease.

If you join the study, you will have professional dental cleanings every three months and will be asked to use the lactoferrin toothpaste twice a day at home. Half of the participants will also use the lactoferrin mouthwash twice daily. Your gum health will be checked at the start and then again at 1, 3, and 6 months to see how well the treatments work. To be eligible, you must be 18 to 45 years old, have at least 20 natural teeth, and not have other health problems or pregnancy complications that could affect your gums or pregnancy. This study aims to find safe and effective ways to help keep gums healthy during pregnancy, which is important for both mother and baby.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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