| CTRI Number |
CTRI/2024/04/065113 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimation of Cost of Dental Caries and Periodontal Disease from Dental Patient perspective. |
|
Scientific Title of Study
|
Cost of Care Associated with Periodontal Disease and Dental Caries – A Mixed method 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 |
Swet Nisha |
| Designation |
PhD Scholar |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Haldia Institute Of Dental Sciences And Research, Department Of Periodontics and Implantology, Division-Dentistry
Medinipur
WEST BENGAL
721645
India |
| Phone |
9883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurag Satpathy |
| Designation |
Professor |
| Affiliation |
Institute Of Dental Sciences |
| Address |
Department of OF Periodontics And Oral Implantology, Institute Of Dental Sciences, Sikha‘O’ Anusandhan(Deemed to be University), Bhubaneshwar
Cuttack
ORISSA
751030
India |
| Phone |
9338333999 |
| Fax |
|
| Email |
drasatpathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Satpathy |
| Designation |
Professor |
| Affiliation |
Institute Of Dental Sciences |
| Address |
Department Of Periodontics And Oral Implantology, Institute Of Dental Sciences,Siksha ‘O’Anusandhan (Deemed To Be University), Bhubaneshwar.
Cuttack
ORISSA
751030
India |
| Phone |
9338333999 |
| Fax |
|
| Email |
drasatpathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Haldia Institute Of Dental Sciences And Research |
|
|
Primary Sponsor
|
| Name |
Swet Nisha |
| Address |
Haldia Institute Of Dental Sciences and Research, Haldia |
| 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 Swet Nisha |
Haldia Institute of Dental Sciences And Research |
Department Of Periodontology, Room no.9 , Division-Dentistry
Medinipur
WEST BENGAL |
9883916227
swetnisha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Haldia Institute of dental sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
educational module |
educational module on cost conscious care ,3 months duration |
| Comparator Agent |
No educational module introduced |
No exposure to cost conscious care module |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone dental treatment for periodontal diseases and dental caries |
|
| ExclusionCriteria |
| Details |
Patients who have undergone dental treatment for diseases/ conditions other than periodontal disease and Dental Caries.
Those unwilling to share information
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of the cost-of care of periodontal diseases and dental caries
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| understand the burden of Periodontal disease and Dental caries in the Indian scenario. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cost of care associated with periodontal disease and dental caries remain unexplored in Indian context. The burden of these non communicable diseases needs to be determined as they have direct impact on patient well being , economy and policy makers. This study aims at determing the cost of care associated with dental caries and periodontal disease. Ou of Pocket expenditure related to Periodontal disease and Dental Caries will be determined . Additionally , Introduction of cost conscious care module will be introduced to undergraduate dental students and its effectiveness will be assesed. |