Lactoferrin oral care to improve gum health during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.