| CTRI Number |
CTRI/2021/04/032899 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Analyse Changes in the Levels of Salivary Lysozyme in Partially Edentulous Patients Before and After Removable Prosthetic Treatment among |
|
Scientific Title of Study
|
Comparative Analysis of Changes in the Levels of Salivary Lysozyme Before and After Removable Prosthetic Treatment among Partially Edentulous Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShefali Dogra |
| Designation |
Pg student |
| Affiliation |
MRIIRS |
| Address |
Department of Prosthodontics, Manav Rachna Dental College, Sector 43, Aravalli Hills.
Manav Rachna Dental College, Sector 43, Aravalli Hills.
Faridabad
HARYANA
121003
India |
| Phone |
7018361830 |
| Fax |
|
| Email |
sdogra94@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Dhawan |
| Designation |
Professor and Head of the department |
| Affiliation |
MRIIRS |
| Address |
Department of Prosthodontics,Manav Rachna Dental College, Sector 43, Aravalli Hills.
Manav Rachna Dental College, Sector 43, Aravalli Hills.
Faridabad
HARYANA
121003
India |
| Phone |
9810050103 |
| Fax |
|
| Email |
dhawan.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrShefali Dogra |
| Designation |
Pg student |
| Affiliation |
MRIIRS |
| Address |
Manav Rachna Dental College, Sector 43, Aravalli Hills.
Manav Rachna Dental College, Sector 43, Aravalli Hills.
Faridabad
HARYANA
121003
India |
| Phone |
7018361830 |
| Fax |
|
| Email |
sdogra94@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS |
|
|
Primary Sponsor
|
| Name |
DrShefali Dogra |
| Address |
Manav Rachna Dental College, Sector 43, Aravalli Hills. |
| Type of Sponsor |
Other [MDS Post-graduate Thesis] |
|
|
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 Shefali Dogra |
Manav Rachna DentalCollege |
Faculty of DentalSciences,Department ofPedodontics andPreventive Dentistry,Room no. 9, ManavRachna InternationalInstitute of ResearchSciences, ManavRachna Campus Rd,Gadakhor Basti Village,Sector 43, Faridabad,Haryana 121004FaridabadHARYANA
Faridabad
HARYANA |
9805215461
sdogra94@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fabriaction of Removable Partial Denture |
The changes in the levels of salivary lysozyme before i.e. at 0 months and after 3 months of RPD insertion |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having partially edentulous arches with more than 3 and less than 6.
Age group between 35-60 years.
Patients who are non-smokers.
Patients wearing dentures for the first time. |
|
| ExclusionCriteria |
| Details |
Patients with very poor oral hygiene having OHI-S score between 3.1-6.0.
Patients taking any kind of medications which may affect salivary secretions from last 3 months.
Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find correlation between concentrations of Lysozyme before i.e. baseline and after three months after insertion of removable partial denture in successive samples of unstimulated saliva collected from partially edentulous patients.
|
The study is conducted at baseline i.e. at 0 months and after 3 months of denture insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in the level of salivary lysozyme before and after the RPD insertion |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2021 |
| Date of Study Completion (India) |
22/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The use
of this study helps to analyse the relationship and association of these
salivary biomarkers which are entities within the body capable of providing impartial
information regarding the current physiologic state of a living organism before
and after comprehensive dental treatment in partially edentulous patients.
There are
a very limited studies on the relationship of salivary lysozyme
concentrations with partially edentulous patients.
This
study helps to monitor the health and disease status through an oral biofluid, saliva
as a credible diagnostic tool. §This
study helps in understanding the role and importance of saliva in the field of Prosthodontics.
To study
the alterations in their concentration that can be
associated with the onset, progression, or even regression of a particular
disorder and could not only provide information concerning disease pathogenesis
and progression but also support their position as evaluators of health. |