NCT07069140 Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
| NCT ID | NCT07069140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pavia |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-30 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Andrea Scribante, Associate Professor
PRINCIPAL INVESTIGATOR
University of Pavia
Frequently Asked Questions
Who can join the NCT07069140 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069140 currently recruiting?
Yes, NCT07069140 is actively recruiting participants. Contact the research team at andrea.scribante@unipv.it for enrollment information.
Where is the NCT07069140 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07069140 clinical trial?
NCT07069140 is sponsored by University of Pavia. The principal investigator is Andrea Scribante, Associate Professor at University of Pavia. The trial plans to enroll 40 participants.