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临床试验/CTRI/2025/08/093633
CTRI/2025/08/093633尚未招募1/2 期

Comparative Evaluation of Chewing Efficiency and Nutritional Status in the Dentures Fabricated using Bioelectric Impression to Conventional Impression: A Randomized Clinical Trial

Sapna Rani1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月8日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Chewing efficiency

研究概览

简要总结

Complete dentures will be fabricated by two techniques: Conventional border molding and impression technique and Border molding and impression making using TENS technique

Chewing efficiency will be measured by EMG with different consistencies of food provided to the patient. Nutritional status will be assessed by a questionnaire (MNA-SF). Statistical analysis will be done.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient with upper and lower edentulous arches b.
  • Patient with healed ridge c.
  • Patient who are ready for follow-up d.
  • Patients with age 45-65 years.

排除标准

  • Patients with ridge defects
  • Patients with any systemic disease that contraindicates electrode placement, e.g., cardiac pacemaker, etc.
  • Patients with poor neuromuscular control, temporomandibular joint pain, psychological disorder.
  • Patients with a single complete denture.

结局指标

主要结局

Chewing efficiency

时间窗: Chewing efficiency after 1 week of insertion

次要结局

  • Nutritional status(pre-denture insertion and 3 months post-denture insertion)

研究者

发起方
Sapna Rani
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Sapna Rani

Professor, Manav Rachna Dental College,SDS, MRIIRS

研究点 (1)

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