NCT07069140

Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Effectiveness of an Oral Care Protocol Based on Lactoferrin Toothpaste and Mouthwash in Pregnant Women for the Prevention of Periodontal Disease: A Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Pavia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy
• Periodontal Disease
• Gingivitis
• Oral Microbiota

Interventions

Type	Name	Description
DRUG	Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)	Participants in the experimental arm will receive professional supragingival and subgingival dental hygiene sessions every three months over a six-month period. In addition, they will follow a home oral care protocol consisting of twice-daily use of a lactoferrin-based toothpaste and a lactoferrin-based mouthwash, both commercially available as Emoform Glic (Polifarma Benessere S.r.l.). The toothpaste will be applied with a soft-bristle toothbrush for two minutes, and the mouthwash will be used at a dosage of 10 mL, rinsed for 60 seconds after toothbrushing, twice a day. The intervention aims to assess whether the combined use of lactoferrin-based toothpaste and mouthwash can enhance clinical outcomes related to plaque accumulation and periodontal inflammation in pregnant women between the fourth and eighth month of gestation.
DRUG	Lactoferrin-Based Toothpaste Only (Emoform Glic)	Participants in the control arm will also undergo professional dental hygiene sessions every three months for a total duration of six months. At home, they will follow an oral hygiene protocol limited to the twice-daily use of a lactoferrin-based toothpaste (Emoform Glic, Polifarma Benessere S.r.l.), applied with a soft-bristle toothbrush for two minutes. No mouthwash will be used in this arm. The purpose of this intervention is to evaluate the effectiveness of lactoferrin toothpaste alone and to serve as an active comparator for assessing the additional benefit of the mouthwash in improving periodontal parameters.

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-06-01
• Completion: 2026-06-10
• First posted: 2025-07-16
• Last updated: 2026-02-20

Locations

1 site across 1 country: Italy