Pregnancy gum shield: new lactoferrin routine tested
NCT ID NCT07069140
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a lactoferrin-based toothpaste and mouthwash twice daily, along with regular professional cleanings, can prevent gum disease in pregnant women. Forty pregnant women in their second trimester will be split into two groups: one using both the toothpaste and mouthwash, and the other using only the toothpaste. The main goal is to see if the full protocol reduces dental plaque buildup over six months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
RECRUITINGPavia, Lombardy, 27100, Italy
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Other studies related to the condition(s) this trial covers.
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