Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Pavia

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)
  • Lactoferrin-Based Toothpaste Only (Emoform Glic)

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators