Actively Recruiting
Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
Led by University of Pavia · Updated on 2026-02-20
40
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged between 18 and 45 years
- Gestational age between 14 and 28 weeks at 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 will not qualify if you...
- History of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunosuppression)
- Antibiotic or anti-inflammatory therapy within 3 months before 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 investigational product components
- Participation in another clinical trial within the previous 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
A
Andrea Scribante, Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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