| CTRI Number |
CTRI/2022/08/045088 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of gum diseases to COVID 19 |
|
Scientific Title of Study
|
Association of periodontitis and severity of COVID 19: A case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC2 - 107 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravya Macherla |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education(MAHE) |
| Address |
Department of Periodontics,
Room no.3,
Manipal college of dental sciences,
Manipal,Udupi,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8333977467 |
| Fax |
|
| Email |
marchelashravya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education(MAHE) |
| Address |
Department of Periodontics,
Room no.3,
Manipal college of dental sciences,
Manipal,Udupi,Karnataka
Udupi
KARNATAKA
57610
India |
| Phone |
9739863908 |
| Fax |
|
| Email |
aditi.chopra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education(MAHE) |
| Address |
Department of Periodontics,
Room no.3,
Manipal college of dental sciences,
Manipal,Udupi,Karnataka
Udupi
KARNATAKA
57610
India |
| Phone |
9739863908 |
| Fax |
|
| Email |
aditi.chopra@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shravya Macherla |
| Address |
Department of Periodontology,
Room no.3,
Manipal college of Dental sciences,Manipal,Udupi,Karnataka-576104 |
| 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 |
| Shravya Macherla |
Manipal college of dental sciences Manipal |
room no 3 department of Periodontology
Udupi
KARNATAKA |
08333977467
marchelashravya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female subjects of age >18 years who had a history of COVID 19 and
have confirmatory RT-PCR report will be included.
2. All participants whose dental records can be retrieved from medical records obtained
from Kasturba medical Hospital.
3. Subjects who have dental records (have visited dental OPD) before the date of onset of
COVID-19 infection. |
|
| ExclusionCriteria |
| Details |
subjects less than 18years of age
subjects with no confirmatory RTPCR report
subjects whose dental and medical records cannot be retrieved
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
presence or absence of bleeding
on probing (BOP) mean pocket depth (PPD) clinical attachment loss(CAL) gingival recession (REC) tooth mobility radiographic bone loss
systemic comorbities
covid19 severity |
baseline (one time analysis) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
demographic data
plaque and calculus levels
smoking history
oral hygiene practices |
baseline (one time analysis) |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
10/09/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study is being conducted after approval from the Institutional ethics committee. It is an Observational case control study being done to know the association between periodontitis(gum disease) and severity of COVID19. For this study, retrospective data will be screened obtained from the Kasturba medical college medical records and dental records. Records will be screened for obtaining the following data: 1.Patients demographic data 2.Date of occurence of Covid19 3.Severity of Covid19 4.Presence of any other systemic comorbities Dental records will be screened to obtain: 1. Date of dental visit 2. presence of plaque and calculus 3. smoking status 4. presence of Bleeding on probing 5. mean probing depth 6. clinical attachment level 7. gingival recession 8. tooth mobility 9. radiographic bone loss 10. periodontal disease status Based on the obtained data the subjects will be grouped under the following categories: 1. Presence of periodontitis and severity of Covid19 2. Absence of periodontitis and severity of Covid19 appropriate statistical analysis will be done on the obtained data to know the association between periodontitis and severity of Covid19
|