| CTRI Number |
CTRI/2024/12/078246 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study on Adverse Events following the use of any Dental Materials in an Outpatient Department of Dentistry at Government Hospitals in Jaipur |
|
Scientific Title of Study
|
A Descriptive Observational Study on Materiovigilance of Dental Materials in an Outpatient Department of Dentistry at Government Hospitals in Jaipur |
| 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 Jaya Sharma |
| Designation |
PhD Scholar |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology, SMS Medical College and Hospital.
JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9783415590 |
| Fax |
|
| Email |
jayasharma155@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Jain |
| Designation |
Sr Professor |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology, SMS Medical College and Hospital.
JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828786533 |
| Fax |
|
| Email |
monicajain07@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Sharma |
| Designation |
PhD Scholar |
| Affiliation |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology, SMS Medical College and Hospital.
JAIPUR
RAJASTHAN
302004
India |
| Phone |
9783415590 |
| Fax |
|
| Email |
jayasharma155@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DENTISTRY SMS HOSPITAL JAIPUR |
| RUHS COLLEGE OF DENTAL SCIENCES JAIPUR |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NO SPONSOR] |
|
|
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 Jaya Sharma |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS |
Department of Dentistry Room Number 447 Fourth Floor
Jaipur
RAJASTHAN |
9783415590
jayasharma155@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients visiting to treating Dental Surgeon on their first scheduled follow-up visit within 3 months period following the use of any Dental materials appliances and prosthesis
More than 18 years of age of either sex
Patient who give their consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Immunocompromised Patients
Patients having Diabetes Mellitus
Pregnant & Lactating females
Patients using immunomodulatory drugs and oral contraceptive pills
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pattern of Adverse Events in percentages |
Within Three months time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the Knowledge, Attitude, Practice and Barriers of reporting Adverse Events |
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
27/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Medical devices are extensively used for the diagnosis, prevention and treatment of different diseases. Even though their use is beneficial to the patients immensely but they also carry significant potential risks. Medical devices are classified into three classes. Dental materials are categorized as Class II medical devices associated with moderate risk according to USFDA. Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurences associated with the use of medical devices.
Materiovigilance in dentistry is relatively a new concept in India and still in an infancy stage and faces many challenges such as lack of awareness, under reporting, inadequate training and insufficient resources.
Therefore it is of utmost importance to promote and strengthen materiovigilance in Dentsitry, by creating a culture of reporting and encouraging research by generating evidence based data on the safety of medical devices. Regarding this very few studies have been planned, so this evidence based research will enhance and give an insight into possible device induced Adverse Events with the objective to study and report the adverse events at patient’s first scheduled follow up visit within 3 months period following the use of prosthesis, appliances and materials used in dentistry in a sample size of 150 patients. |