| CTRI Number |
CTRI/2024/07/071718 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Breath analysis of the patients with few missing teeth after the placement of removable artificial teeth set |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prudhvi Rudaraju |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics,
Room no-8
Block No-2
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7032694963 |
| Fax |
|
| Email |
prudhvi.1922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Sajjan MC |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics,
Room no-8
Block No-2
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9949433567 |
| Fax |
|
| Email |
sureshsajjanmc@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Sajjan MC |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics,
Room no-8
Block No-2
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9949433567 |
| Fax |
|
| Email |
sureshsajjanmc@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Vishnupur,
Bhimavaram,
534202,
West Godavari District,
Andhra Pradesh,
India |
|
|
Primary Sponsor
|
| Name |
Dr.Prudhvi Rudraraju |
| Address |
Department of Prosthodontics,
Room no-8,
Block-2,
Vishnu Dental College,
Vishnupur,
Bhimavaram,
534202,
India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prudhvi Rudraraju |
Vishnu Dental College |
Department of Prosthodontics,
Room no-8,
Block-2,
Vishnupur,
Bhimavaram,
534202,
India.
West Godavari
ANDHRA PRADESH |
7032694963
prudhvi.1922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Vishnu Dental College. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post treatment |
after rehabilitation with removable partial denture fabrication in partially edentulous patients(Kennedys class I patients) the lung volumes and lung capacities will be measured using spirometer. Retropharyngeal airway space will be measured using cephalogram and the details will be recorded. |
| Comparator Agent |
Pre treatment |
Before the fabrication of removable partial denture for partially edentulous patients(Kennedys class I patients) the lung volumes and lung capacities will be measured using spirometer. Retropharyngeal airway space will be measured using cephalogram and the details will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Kennedy’s class-I partially edentulous condition in maxillary or mandibular arch with more than six missing teeth
2. Remaining teeth intact in arch with or without restoration
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Baseline, Day 0, 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in retropharyngeal space in cephalometric analysis before and after the rehabilitation with removable partial denture |
Baseline, Day 0, 90 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 4) To record the lateral cephalogram after 3 months of rehabilitation to evaluate retropharyngeal space 5) 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.
|