Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

NCT ID: NCT07069140

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2026-02-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactoferrin Toothpaste + Mouthwash

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.

Group Type: EXPERIMENTAL

Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic)

Intervention Type: DRUG

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.

Lactoferrin Toothpaste

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.

Group Type: ACTIVE_COMPARATOR

Lactoferrin-Based Toothpaste Only (Emoform Glic)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Scribante, Associate Professor

Role: CONTACT

andrea.scribante@unipv.it

+39 0382516223

Facility Contacts

Andrea Scribante, Associate Professor

Role: primary

andrea.scribante@unipv.it

+39 0382516223

Other Identifiers

2025-LBCGEST

Identifier Type: -

Identifier Source: org_study_id