Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Change in dental plaque accumulation measured by Plaque Index (PI) [Срок оценки: Baseline (T0) to Month 6 (T3)]

Вторичные конечные точки (8)

• Change in gingival bleeding measured by Bleeding on Probing (BoP) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in periodontal pocket depth measured by Probing Pocket Depth (PPD) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in connective tissue attachment loss measured by Clinical Attachment Level (CAL) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in gingival inflammation severity measured by Modified Gingival Index (MGI) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in interproximal plaque accumulation measured by Approximal Plaque Index (API) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in global plaque distribution measured by Plaque Control Record (PCR%) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in localized gingival inflammation measured by Papillary-Marginal-Gingival Index (PMGI) [Срок оценки: Baseline (T0) to Month 6 (T3)]
• Change in soft tissue loss measured by Gingival Recession (R) [Срок оценки: Baseline (T0) to Month 6 (T3)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Идентификаторы

NCT: NCT07069140 · 2025-LBCGEST

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗