Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic), Lactoferrin-Based Toothpaste Only (Emoform Glic).
- Who it may be relevant to
- Registry conditions: Pregnancy, Periodontal Disease, Gingivitis, Oral Microbiota. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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 - 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 t
Primary outcome measures
- Change in dental plaque accumulation measured by Plaque Index (PI) [Time frame: Baseline (T0) to Month 6 (T3)]
Secondary outcome measures (8)
- Change in gingival bleeding measured by Bleeding on Probing (BoP) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in periodontal pocket depth measured by Probing Pocket Depth (PPD) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in connective tissue attachment loss measured by Clinical Attachment Level (CAL) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in gingival inflammation severity measured by Modified Gingival Index (MGI) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in interproximal plaque accumulation measured by Approximal Plaque Index (API) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in global plaque distribution measured by Plaque Control Record (PCR%) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in localized gingival inflammation measured by Papillary-Marginal-Gingival Index (PMGI) [Time frame: Baseline (T0) to Month 6 (T3)]
- Change in soft tissue loss measured by Gingival Recession (R) [Time frame: Baseline (T0) to Month 6 (T3)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT07069140 · 2025-LBCGEST