A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 746
- 试验地点
- 2
- 主要终点
- Change From Baseline in Löe-Silness Gingivitis Index
研究概览
简要总结
This study will track changes in oral health in pregnant women. Subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. A comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •be at least the age of legal consent;
- •be between 8 and 24 weeks of pregnancy;
- •have at least 20 natural teeth;
- •have moderate-to-severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding.
排除标准
- •evidence of multiple gestations;
- •history of HIV infection, AIDS, autoimmune disease, or diabetes other than gestational diabetes;
- •indication for use of antibiotic pre-medication prior to dental procedures;
- •systemic corticosteroid or immunosuppressive therapy within 1 month of Baseline;
- •severe periodontal disease, rampant untreated dental caries, or other oral conditions that necessitate immediate dental care;
- •ongoing dental care that in the opinion of the investigator could impact study participation;
- •a history of allergies or hypersensitivity to mouth rinse products containing CPC;
- •any disease or condition that in the opinion of the investigator could interfere with the safe completion of the study;
- •randomization to a treatment in study 2011001 during a prior pregnancy.
研究组 & 干预措施
Regular Oral Hygiene
toothpaste, toothbrush and dental floss
干预措施: toothbrush (Device)
Regular Oral Hygiene
toothpaste, toothbrush and dental floss
干预措施: dental floss (Device)
Regular Oral Hygiene
toothpaste, toothbrush and dental floss
干预措施: 0.243% sodium fluoride (Drug)
Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
干预措施: 0.454% stannous fluoride (Drug)
Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
干预措施: toothbrush (Device)
Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
干预措施: 0.07% Cetylpyridinium chloride (Drug)
Advanced Oral Hygiene plus counseling
toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
干预措施: dental floss (Device)
结局指标
主要结局
Change From Baseline in Löe-Silness Gingivitis Index
时间窗: 1 month
Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
次要结局
- Gestational Age (Weeks)(At delivery)