Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Effectiveness of an Oral Care Protocol Based on Lactoferrin Toothpaste and Mouthwash in Pregnant Women for the Prevention of Periodontal Disease: A Randomized Controlled Clinical Trial

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. The trial group will undergo professional dental cleaning every three months and will perform home oral hygiene using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic) twice daily. The control group will follow the same schedule of professional dental cleanings but will use only the lactoferrin-based toothpaste (Emoform Glic) at home. The primary objective is to assess the reduction in dental plaque, measured by the Plaque Index (PI). Secondary outcomes include improvements in gingival inflammation, probing pocket depth, clinical attachment level, and other periodontal indices. Participants will be followed for six months, with evaluations conducted at baseline, 1, 3, and 6 months.

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