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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in dental plaque accumulation measured by Plaque Index (PI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lactoferrin Toothpaste + Mouthwash
Participants randomized to this arm will undergo professional dental hygiene sessions every 3 months and will perform home oral care using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic). They will be instructed to brush their teeth twice daily using the toothpaste and to rinse with 10 mL of mouthwash for 60 seconds twice daily, for a total study duration of 6 months. The intervention aims to evaluate the added benefit of combining both products on plaque accumulation and periodontal inflammation in pregnant women between the 4th and 8th month of gestation.
干预措施: Lactoferrin-based Toothpaste and Mouthwash (Emoform Glic) (Drug)
Lactoferrin Toothpaste
Participants randomized to this arm will also undergo professional dental hygiene sessions every 3 months. For home care, they will use only the lactoferrin-based toothpaste (Emoform Glic), brushing twice daily for 2 minutes following standard oral hygiene instructions. No mouthwash will be used. This group serves as the active comparator to determine whether the addition of the lactoferrin-based mouthwash provides any significant clinical advantage.
干预措施: Lactoferrin-Based Toothpaste Only (Emoform Glic) (Drug)
结局指标
主要结局
Change in dental plaque accumulation measured by Plaque Index (PI)
时间窗: Baseline (T0) to Month 6 (T3)
The primary outcome of this study is the change in dental plaque levels assessed using the Plaque Index (PI) developed by Silness and Löe. This index measures the thickness of dental plaque at the gingival margin. For each participant, four surfaces of each tooth (buccal, lingual, mesial, and distal) are examined and scored on a scale from 0 to 3. A score of 0 corresponds to the absence of plaque. A score of 1 indicates the presence of a plaque film only visible with a disclosing agent or by using a periodontal probe. A score of 2 indicates visible moderate plaque accumulation at the gingival margin, while a score of 3 reflects heavy plaque deposits within the gingival sulcus and around the gingival margin. The final PI for each subject is obtained by calculating the mean of all recorded surface scores. This measure provides a continuous variable where higher scores represent greater plaque accumulation and worse oral hygiene. The index will be recorded at four time points: baseline (
次要结局
- Change in gingival bleeding measured by Bleeding on Probing (BoP)(Baseline (T0) to Month 6 (T3))
- Change in periodontal pocket depth measured by Probing Pocket Depth (PPD)(Baseline (T0) to Month 6 (T3))
- Change in connective tissue attachment loss measured by Clinical Attachment Level (CAL)(Baseline (T0) to Month 6 (T3))
- Change in gingival inflammation severity measured by Modified Gingival Index (MGI)(Baseline (T0) to Month 6 (T3))
- Change in interproximal plaque accumulation measured by Approximal Plaque Index (API)(Baseline (T0) to Month 6 (T3))
- Change in global plaque distribution measured by Plaque Control Record (PCR%)(Baseline (T0) to Month 6 (T3))
- Change in localized gingival inflammation measured by Papillary-Marginal-Gingival Index (PMGI)(Baseline (T0) to Month 6 (T3))
- Change in soft tissue loss measured by Gingival Recession (R)(Baseline (T0) to Month 6 (T3))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia