Lactoferrin oral care to improve gum health during 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
This will test whether adding a lactoferrin mouthwash to lactoferrin toothpaste plus regular professional cleanings improves gum health in pregnant women 14–28 weeks into pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07069140 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial will enroll 40 pregnant women in their second trimester and randomly assign them to two home-care regimens combined with professional dental cleanings every three months. The intervention group will use both a lactoferrin-based toothpaste and lactoferrin-based mouthwash, while the control group will use only the lactoferrin-based toothpaste. Participants will be followed for six months with periodic periodontal examinations. The primary outcome is reduction in dental plaque measured by the Plaque Index, with secondary outcomes including gingival inflammation, probing pocket depth, clinical attachment level, and other periodontal indices.
Who should consider this trial
Good fit: Women aged 18–45 who are 14–28 weeks pregnant, have periodontitis (Stages I–III, Grades A–B), at least 20 natural teeth, and can attend follow-up visits are ideal candidates.
Not a fit: People with systemic diseases affecting periodontal status, recent antibiotic or periodontal treatment, current smokers, those with high-risk pregnancies or allergies to product components, or those using conflicting medications/supplements are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could reduce dental plaque and gum inflammation during pregnancy using accessible home oral-care products alongside routine cleanings.
How similar studies have performed: Laboratory work and small clinical studies suggest lactoferrin can reduce oral pathogens and plaque, but this specific lactoferrin mouthwash-plus-toothpaste regimen in pregnant women is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Lombardy
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.