跳至主要内容
临床试验/CTRI/2026/04/107423
CTRI/2026/04/107423尚未招募不适用

Impact of conventional versus functional palatal contours of maxillary complete denture on speech in completely edentulous patients.

PGIMER1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年4月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
PGIMER
入组人数
28
试验地点
1

研究概览

简要总结

This study is a randomized crossover clinical trail, comparing complete dentures with functional palatal contours and conventional complete dentures with flat palate for completely edentulous patients with sample size of total 28 people with no teeth who needs new dentures for the first time, the study will be conducted in OHSC, PGIMER, Chandigarh, the primary outcome measures the acoustic analysis before the treatment and the after 1 month of delivering interventional denture and then crossover with wash out period of 1 week and then after 1 month of comparator denture so totally primary outcome is checked at 3 period of time, secondary outcomes are intelligibilty test, articulation proficiency and nasalance at the same 3 period of time.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients seeking new complete dentures for the first time.
  • Patients who had been completely edentulous for at least 3 months.
  • Age: 45-65 years.
  • Patients who comes under class I and class II of ACP classification of completely edentulous patients.
  • Patients who can read Hindi or Punjabi.
  • Patients who will sign consent form.

排除标准

  • Patients with any congenital or acquired maxillofacial defects.
  • Head and neck cancer patients with history of surgical resection or radiotherapy or planned for the same.
  • Patients with severe underlying medical conditions, neuromuscular dysfunction, auditory problems, mental conditions, oral pathology or xerosthomia.

研究者

发起方
PGIMER
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

H HARSHITHA

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

研究点 (1)

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