CTRI/2024/11/076897尚未招募3 期
Evaluation of the efficacy of virgin coconut oil as compared to Miconazole in the treatment of denture stomatitis; an in vivo study
S Nandakumar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Resolution of denture stomatitis
研究概览
简要总结
A 6 month study aimed to compare the effects of virgin coconut oil and miconazole cream on denture stomatitis. The evaluation is done via visual observation as well as microbiological culture study to detect the presence or absence of candida albicans, which is the major cause for denture stomatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients wearing dentures that cover the entire palate, i.e., complete dentures or partial dentures of the maxillary arch.
- •Patients who present with Type I, Type II or Type III denture stomatitis (According to Newton’s classification).
排除标准
- •Patients who are medically immunocompromised and thus more susceptible to repeated candida infection
- •Patients with uncontrolled diabetes (HbA1c% above 8%)
- •Patients undergoing chemo or radiotherapy
- •Patients with renal insufficiency
- •Patients with AIDS
- •Patients who have undergone organ transplant
- •Patients who have undergone recent or multiple surgeries
- •Patients who are pregnant or nursing
- •Patients with xerostomia
- •Patients who had taken antibiotics or antifungal agents in the past 4 weeks.
结局指标
主要结局
Resolution of denture stomatitis
时间窗: 1-6 months
次要结局
- No resolution of denture stomatitis(1-6 months)
研究者
Nandakumar Subramanian
Department of Prosthodontics
研究点 (1)
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