Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

January 30, 2026

Study Completion Date

February 15, 2026

Conditions
PregnancyPeriodontal DiseaseGingivitisOral Microbiota
Interventions
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.

Trial Locations (1)

27100

RECRUITING

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

All Listed Sponsors
lead

University of Pavia

OTHER

NCT07069140 - Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy | Biotech Hunter | Biotech Hunter