drugset / Trial / NCT07069140

Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

NCT07069140

Recruiting 40 enrolled University of Pavia
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-07-30
Primary completion
2026-06-01
Completion
2026-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactoferrin Protein / enzyme biologic 10 ml