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临床试验/CTRI/2024/07/071718
CTRI/2024/07/071718招募中不适用

A spirometric analysis of the changes in lung functions in partially edentulous patients pre and post- rehabilitation with removable partial denture- A prospective clinical study

Dr.Prudhvi Rudraraju1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Spirometric analysis of parameters like forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate before and after rehabilitation with removable partial denture.

研究概览

简要总结

Aim: To analyse the differences in lung functions in partially edentulous patients pre and post rehabilitation with removable partial denture using spirometer.

Objectives:

  1. To record forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate in kennedy class- I patients before rehabilitaion using spirometer.

  2. To record the lateral cephalogram before rehabilitation to evaluate retropharyngeal space

3)  To record forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate in kennedy class- I patients after rehabilitaion using spirometer

  1. To record the lateral cephalogram after 3 months of rehabilitation to evaluate retropharyngeal space

  2. To evaluate forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate in kennedy class- I patients 3 months after rehabilitaion using spirometer.

Methodology::

Patients visiting the Department Of Prosthodontics (Vishnu Dental College) with bilaterally edentulous maxillary or mandibular  posterior teeth fulfilling the inclusion criteria will be explained about the nature of the study and informed consent will be obtained. Detailed Case history will be recorded and a clinical examination of the edentulous area will be conducted. A Lateral cephalogram will be obtained . Each  patient will be instructed to rinse their mouth. Patient will be given a video demonstration and an actual demonstration on how to perform the  Spirometric test. Patients will be made to sit and relax for 10 minutes to overcome exertion before performing spirometric test.. Patients will be instructed to take deep inspiration and forceful expiration of air into the spirometer minimum 3 times. Removable partial denture will be fabricated by conventional method. Post rehabilitation, Spirometric analysis will be conducted to record the lung functions using digital spirometer with helios 401 software. Patient will be recalled after 3 months, spirometric recording will be done and lateral cephalogram will be obtained. The data obtained will be subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Kennedy’s class-I partially edentulous condition in maxillary or mandibular arch with more than six missing teeth
  • Remaining teeth intact in arch with or without restoration.

排除标准

  • 1.Patients of COPD/respiratory tract infection 2.Patients of congenitally missing teeth 3.Patients who were unwilling to undergo the spirometry tests or returning for follow up.

结局指标

主要结局

Spirometric analysis of parameters like forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate before and after rehabilitation with removable partial denture.

时间窗: Baseline, Day 0, 90

次要结局

  • Increase in retropharyngeal space in cephalometric analysis before and after the rehabilitation with removable partial denture(Baseline, Day 0, 90)

研究者

发起方
Dr.Prudhvi Rudraraju
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prudhvi Rudaraju

Vishnu Dental College

研究点 (1)

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