Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Recruiting now · Not applicable

Conditions studied: Pregnancy, Periodontal Disease, Gingivitis, Oral Microbiota

In brief

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.

Key facts

Study ID

NCT07069140

Run by

University of Pavia

People needed

40

Starts

2025-07-30

Expected to finish

2026-06-10

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify 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
• Signed informed consent

You may not qualify 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 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

Where it is running

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.