Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Candida species colony forming units
研究概览
简要总结
Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers.
The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common.
The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Wearing a maxillary and mandibular complete conventional denture
- •Having moderate to severe signs of denture stomatitis according to Schwartz index
- •Providing consent prior to study.
排除标准
- •Oral mucosal lesions other than denture stomatitis.
- •Systemic conditions which predispose to Candida specie infection such as uncontrolled diabetes and xerostomia.
- •History of chemotherapy/radiotherapy.
- •Used antibiotics, steroidal or antifungal agents in the 4 weeks prior to the study.
- •Scheduled to replace existing dentures with new ones during the length of the trial.
- •Already using palatal brushing as a routine oral hygiene procedure.
研究组 & 干预措施
Palate Brushing
In this group the intervention is "palatal brushing", performed by the participants following each meal for a period of 6 months. This will be performed using the provided toothbrush (device). The results will determine if brushing the palate in an efficient intervention for reducing the microbial count and inflammation associated with denture stomatitis.
干预措施: Palatal brushing (Behavioral)
Regular Oral Hygiene
The participants in this study arm will not be prescribed or allocated any intervention. The participants will be asked to continue with the regular hygiene and denture maintenance practices for the duration of the trial.
结局指标
主要结局
Candida species colony forming units
时间窗: Baseline to 6 months
Palatal saliva (swab) and denture sonicate will be analysed for Candida species CFU count at baseline, 3 months and 6 months. The results will be presented as change in mean CFU count.
次要结局
- Clinical Inflammation(Baseline to 6 months)
研究者
Elham Emami
Associate Professor
Université de Montréal