Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy (LBC-PREG)

University of Pavia

Status: Begins enrollment this month

Conditions: Oral Microbiota; Periodontal Disease; Gingivitis; Pregnancy

Treatments: Drug: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic); Drug: Lactoferrin-Based Toothpaste Only (Emoform Glic)

Study type: Interventional

Funder types: Other

Identifiers

NCT07069140

2025-LBCGEST

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Willingness to comply with study procedures and attend follow-up visits
• Signed informed consent

Exclusion criteria

• 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)
• Smoking or tobacco use
• Known allergy to any of the investigational product components
• Participation in another clinical trial within the previous 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Lactoferrin Toothpaste + Mouthwash

Experimental group

Description:

Participants randomized to this arm will undergo professional dental hygiene sessions every 3 months and will perform home oral care using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic). They will be instructed to brush their teeth twice daily using the toothpaste and to rinse with 10 mL of mouthwash for 60 seconds twice daily, for a total study duration of 6 months. The intervention aims to evaluate the added benefit of combining both products on plaque accumulation and periodontal inflammation in pregnant women between the 4th and 8th month of gestation.

Treatment:

Drug: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)

Lactoferrin Toothpaste

Active Comparator group

Description:

Participants randomized to this arm will also undergo professional dental hygiene sessions every 3 months. For home care, they will use only the lactoferrin-based toothpaste (Emoform Glic), brushing twice daily for 2 minutes following standard oral hygiene instructions. No mouthwash will be used. This group serves as the active comparator to determine whether the addition of the lactoferrin-based mouthwash provides any significant clinical advantage.

Treatment:

Drug: Lactoferrin-Based Toothpaste Only (Emoform Glic)