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临床试验/CTRI/2017/04/008314
CTRI/2017/04/008314进行中(未招募)2 期

Comparative evaluation of the effect of denture adhesives with probiotics on colony forming units of candida and retention in completely edentulous patients wearing complete dentures. A randomized controlled trial.

Tamanna M Chhabra1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年3月15日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
65
试验地点
1
主要终点
1. Colony forming unit of candida CFU/ul

研究概览

简要总结

This study is a randomised controlled trial with a cross over design to find out the effect of probiotics added to denture adhesives on the colony forming units of candida in the oral cavity in complete denture wearers and its effect on retention of the denture . It has been proved that probiotics bring down the candida infection level  in oral cavity in complete denture patients.A trial product was generated where probiotics of the total power of 10raise to power 8 containing lactobacillus rhamnosus,lactobacillus acidophilus and bifidobacterium bifidum. the primary outcome assessed will be CFU/uL and retention in Complete denture patients in N-Cm.  Candida is a normal commensal of the oral cavity but it can become can turn pathogenic in patients who are immunocompromised.Denture adhesives enhance retention in the dentures.Therefore they are commonly prescribed in denture wearing patients. It has also been shown that denture adhesives can increase the risk of candida in denture wearing patients if they do not maitain hygiene adequately. therefore there was need to generate a product which can enhance the retention of the denture at the same time prevent candida growth under the denture in healthy and in immunocompromised patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
50.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • a.Completely edentulous patients b.
  • Patients who will be not using antibiotics, antifungals or probiotics in any form.
  • Patients who will be asymptomatic candida carriers in oral cavity d.
  • Patients who will understand and will be ready to be part of the study.

排除标准

  • Patients suffering from any chronic debilitating disorder b.
  • Inability to understand and be part of the study.

结局指标

主要结局

1. Colony forming unit of candida CFU/ul

时间窗: 5 weeks

2. Retention of upper denture N-cm

时间窗: 5 weeks

次要结局

  • there are no secondary outcomes(there are no secondary outcomes)

研究者

发起方
Tamanna M Chhabra
申办方类型
Other [Individual ,PhD Thesis]

研究点 (1)

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