| CTRI Number |
CTRI/2024/04/064983 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bengali Version of Oral Health Impact Profile among Bengali Speaking Adult Population |
|
Scientific Title of Study
|
Validation of a Bengali version of oral health impact profile-14 (OHIP-14 Bengali) |
| 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 |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Haldia Institute Of Dental Sciences And Research, Department Of Periodontology, Room No. 9 , Division-Dentistry
Medinipur
WEST BENGAL
721645
India |
| Phone |
9883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swet Nisha |
| Designation |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Haldia Institute Of Dental Sciences And Research, Department Of Periodontology, room no. 9 , Division -Dentistry
Medinipur
WEST BENGAL
721645
India |
| Phone |
07595800724 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swet Nisha |
| Designation |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Haldia Institute Of Dental Sciences And Research, Department Of Periodontology, Room No. 9, Division-Dentistry
Medinipur
WEST BENGAL
721645
India |
| Phone |
07595800724 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Haldia Institute Of Dental Sciences And Research |
|
|
Primary Sponsor
|
| Name |
Swet Nisha |
| Address |
Department of Periodontology , Haldia Institute Of Dental Sciences and Research, Haldi-721645,West Bengal,India |
| 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 |
| Swet Nisha |
Haldia Institute Of Dental Sciences And Research |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
who could understand Bengali language and who were above the age of 18 years |
|
| ExclusionCriteria |
| Details |
Those unwilling to participate, seeking
consultation for acute pain, having cognitive impairment, and
alcoholism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Health Impact Profile -14 Bengali version validation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reliability was measured in terms of internal consistency
using Cronbach’s alpha which assesses the overall correlation
between items within a scale. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
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="3"
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
|
Oral Health Impact Profile-14 has been used widely for Oral Health Related Quality of Life assessment . However, the orginal questionnaire is in English and to conduct a study we need a bengali version to suit to local dialect of bengali speaking adult poputation. The present study aims at validation of Bengali version of OHIP-14 among Bengali Speaking adult population. |