| CTRI Number |
CTRI/2021/08/035367 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the relation between anxiety during dental treatment, habit of clenching of teeth and type of personality |
|
Scientific Title of Study
|
Association of Personality traits and dental anxiety to self-reported bruxism among students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lee Chia Sien |
| Designation |
Undergraduate student |
| Affiliation |
Faculty of Dentistry, Melaka Manipal Medical College |
| Address |
Faculty of Dentistry, Melaka Manipal Medical College, Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922849 |
| Fax |
|
| Email |
leechiasien21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Shetty |
| Designation |
Associate Professor |
| Affiliation |
Melaka Manipal Medical College |
| Address |
Melaka Manipal Medical college
Madhav Nagar
Melaka Manipal Medical college
Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
08202922849 |
| Fax |
|
| Email |
drsmithashetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Shetty |
| Designation |
Associate Professor |
| Affiliation |
Melaka Manipal Medical College |
| Address |
Melaka Manipal Medical college
Madhav Nagar
Melaka Manipal Medical college
Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
08202922849 |
| Fax |
|
| Email |
drsmithashetty@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Dentistry, Melaka Manipal Medical College |
|
|
Primary Sponsor
|
| Name |
Faculty of Dentistry Melaka Manipal Medical College |
| Address |
Madhava Nagar, Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Malaysia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smitha Shetty |
Melaka Manipal Medical College |
Department of Oral Biology, 5th floor, Room: 5b. Madhava Nagar. Manipal
Udupi
KARNATAKA |
08202922849
drsmithashetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hosipital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K030||Excessive attrition of teeth, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students who are willing to take part in the study |
|
| ExclusionCriteria |
| Details |
Students not willing to participate will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Individual’s personality: from Big Five Inventory questionnaire
Dental Anxiety: Presence /Absence from Modified Dental Anxiety Scale questionnaire
Bruxism: Presence/Absence from questionnaire
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between type of personality with Bruxism and dental anxiety |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="50"
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)
|
31/08/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental anxiety remains a barrier to dental care making self-awareness important for a considerable proportion of the population. Similarly Bruxism or clenching of teeth has also been reported to be due to stress but the pathophysiology has not been clearly understood. Hence understanding the prevalence of bruxism and its association with dental anxiety and personality is important to understand its aetiology. The aim of this study was to investigate the association between personality and dental anxiety with self-reported bruxism-related symptoms among students.
|