Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT07069140

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

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy | DecenTrialz