| CTRI Number |
CTRI/2021/01/030522 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COVID and dental treatment |
|
Scientific Title of Study
|
Knowledge and apprehension of Dental Patients receiving dental treatment about COVID 19: A questionnaire study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS, Manipal |
| Address |
Department of Oral Surgery ,Manipal College of Dental Sciences , Manipal
Manipal college of dental sciences , Manipal
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
drandymanipal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS, Manipal |
| Address |
Department of Oral Surgery ,
MCODS , Manipal
Manipal college of dental sciences , Manipal
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
drandymanipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS, Manipal |
| Address |
Department of Oral Surgery ,
MCODS , Manipal
Manipal college of dental sciences , Manipal
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
drandymanipal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences , Manipal |
|
|
Primary Sponsor
|
| Name |
anand deep shukla |
| Address |
department of oral surgery
MCODS, Manipal |
| Type of Sponsor |
Other [self sponsoring ] |
|
|
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 |
| Anand deep shukla |
MCODS , Manipal |
Department of Oral Surgery,
MCODS , Manipal.
Room number 4
576104
Udupi
KARNATAKA |
9742354052
drandymanipal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients visiting dental OPD for dental procedures
2) Patients above 18 years of age
3) Patients who are able to read and write English or kannada
|
|
| ExclusionCriteria |
| Details |
1) Patients below 18 years of age
2) Patients who are unable to read English or Kannada
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the knowledge about COVID 19 amongst dental patients .
2) To assess what apprehensions patients have when they visit a dental clinic during these times .
|
6 months : After the study is complete the data would be analysed statistically
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge of patients visiting OPD and the necessary modifications in our treatment protocol to be made . |
Over a period of one year |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
28/02/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID 19 has affected the entire human population . The cases are increasing world wide . Dental treatment is associated with high transmission of COVID 19 . This study is an attempt to know about the patients knowledge and apprehensions about getting dental treatment in this COVID era . This would help us to prepare better for the management of patients and to nullify their fears . |