| CTRI Number |
CTRI/2024/05/067656 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Is oral health important or not : A study among prosthodontic patients |
|
Scientific Title of Study
|
Quantifying health utilities of adult prosthodontic patients using the time trade-off method: A cross-sectional 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 |
Dr Bidisha Sarmah |
| Designation |
Post-graduate Students |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no. 8, Dept of Public health dentistry, Manipal
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09634618113 |
| Fax |
|
| Email |
bidisha1sarmah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashidhar Acharya |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no. 8, Dept of Public health dentistry, Manipal
Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448127031 |
| Fax |
|
| Email |
sh.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashidhar Acharya |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no. 8, Dept of Public health dentistry, Manipal
Manipal College of Dental Sciences, Manipal
KARNATAKA
576104
India |
| Phone |
9448127031 |
| Fax |
|
| Email |
sh.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences.
Room no. 8, Department of Public Health Dentistry, MCODS, Manipal, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Bidisha |
| Address |
Room no 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal - 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 |
| Dr Bidisha |
T M A Pai Hospital |
Dept of Public health dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA |
09634618113
bidisha1sarmah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital IEC-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects who have missing teeth and want to get it replaced |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female participants above 18 years of age.
Participants who can read, write, and understand Kannada or English.
Participants who are either having one or more missing teeth or are already prosthesis wearers are included |
|
| ExclusionCriteria |
| Details |
Participants who do not have the knowledge of English or Kannada.
Participants who are not willing to participate in the study.
Participants who are suffering from any psychological illness which prevents them from participating in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time-Trade-off in years |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
oral health-related quality of life (OHRQoL)
scores. |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
21/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/10/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Time-Trade-Off is a method used to elicit individuals’ preferences for different health states. Items widely used in health economics and outcomes research to measure the quality of life associated with various health conditions. We can conclude and render better treatment options by analyzing the data and considering the patient’s psyche. A patient in the Dental OPD complaining of missing teeth is mainly concerned with three problems- aesthetics, phonetics, and functional capability. Understanding the effects of treatment to replace teeth on oral health-related quality of life (OHRQoL) is an important aspect of clinicians. No studies have been conducted that imply studying the feasibility of the time trade-off method in prosthodontic patients and their preferences and choices. This study investigates the various factors that determine a patient’s choice of treatment in the department, mainly focusing on Time-Trade-Off principles. Participant Information Sheets and Informed Consent Forms for clinical examination will be given to the participants willing to participate in the study. Only the participants who are either coming for the first time to get a prosthesis or are already prosthesis wearers will be selected. A standard questionnaire is distributed; each participant is expected to answer within 15 minutes. The participants are asked to choose between two alternatives: A. Living for a specified amount of time in a less desirable health state. B. Living for a shorter amount of time in full health. The point at which a participant is indifferent between the two options provides a measure of their value on their current health state compared to full health. This will allow us to understand the effects of treatment on oral health-related quality of life (OHRQoL) |