Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Palatal Inflammation
研究概览
简要总结
Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.
However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.
After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).
Tested Hypotheses:
- There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
- There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health.
- •Completely edentulous maxilla.
- •Currently wearing complete upper dentures.
- •A clinical diagnosis of denture stomatitis.
排除标准
- •Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
- •Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
- •Previous palatal brushing habit.
- •Changing of the existing prosthesis during the trial.
结局指标
主要结局
Palatal Inflammation
时间窗: 3 months
Modified Newton classification 0: Healthy mucosa 1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation 1. Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue 2. Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue 3. Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index 0: Normal tissue 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)
次要结局
- Candida Species Count(3 months)
研究者
Elham Emami
D.D.S., M. Sc., Ph. D, Assistant Professor
Université de Montréal