跳至主要内容
临床试验/CTRI/2021/07/035238
CTRI/2021/07/035238进行中(未招募)不适用

Clinical efficacy of two denture adhesives among complete denture patients: A cross-over randomized clinical trial

Janaki Ramesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Masticatory efficiency assessed by the sieve method (Edlund and Lamm Index)

研究概览

简要总结

There is an increase in the population of geriatric patients in ourcountry many of whom lack access to basic dental care which is linked to anincreased incidence of tooth loss. In this scenario, even though there are variousfixed implant-supported prosthetic options available, most of the completelyedentulous patients cannot afford them and are ultimately provided with completedentures. Complete dentures sometimes lack sufficient retention as a result ofcompromised anatomical situations like resorbed ridges. In such cases, the useof denture adhesives may improve retention and stability and thereby providebetter masticatory function to these patients. However, there is insufficient knowledge among practitioners andpatients regarding the uses and the benefits of these materials. There are alsovery few studies assessing the masticatory efficiency following the use of commerciallyavailable denture adhesives especially in the Indian population. Hence, this study was designed to compare the masticatory efficiency and satisfactionof complete denture wearers using two different forms of commercially availabledenture adhesives and also compare them with the baseline values without denture adhesive and the masticatory efficiency of dentate patients serving as a control.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • •For edentate group: Adults with completely edentulous maxilla and mandible with satisfactory denture bearing area according to Kapur KK (1967) and new prosthesis placed atleast 1 month before but not more than 1 year before the study with the dentures meeting the clinically good dentures criteria of Kapur KK (1967).
  • •For dentate group: Adults with at least 24 teeth present.

排除标准

  • •For edentate group:
  • •Presence of any active oral pathology.
  • •Known allergy to any of the components in the adhesives used.
  • •Presence of uncontrolled systemic disease or any physical or mental disability.
  • •For dentate group: 1.

结局指标

主要结局

Masticatory efficiency assessed by the sieve method (Edlund and Lamm Index)

时间窗: 0,7 and 21 days

次要结局

  • Patient satisfaction assessed by a specially designed questionnaire.(7 and 21 days)

研究者

发起方
Janaki Ramesh
申办方类型
Other [self]

研究点 (1)

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