| CTRI Number |
CTRI/2025/02/081458 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Link Between Dermatoglyphics and Childrens Behavior During Dental Restorative Treatment A Cross Sectional Study |
|
Scientific Title of Study
|
Association of Dermatoglyphics with childs behavior during dental treatment 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 |
Mrunal Pawar |
| Designation |
Post Graduate |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences department of Paedodontics room no 43
Krishna Vishwa Vidyapeeth Malkapur Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
09405155367 |
| Fax |
|
| Email |
mrunalpawar6397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashikiran N D |
| Designation |
Head of Department of Paedontics department and Dean School of Dental Sciences |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences department of Paedodontics room no 43
Krishna Vishwa Vidyapeeth Malkapur Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9630070092 |
| Fax |
|
| Email |
drndshashikiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrunal Pawar |
| Designation |
Post Graduate |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences department of Paedodontics room no 43
Krishna Vishwa Vidyapeeth Malkapur Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
09405155367 |
| Fax |
|
| Email |
mrunalpawar6397@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Dental Sciences Krishna Vishwa Vidyapeeth Karad 415110 district Satara maharashtra India |
|
|
Primary Sponsor
|
| Name |
School of Dental Sciences Krishna Vishwa Vidyapeeth Karad |
| Address |
School of Dental Sciences Krishna Vishwa Vidyapeeth Karad 415110 district Satara maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mrunal Pawar |
Krishna Vishwa Vidyapeeth Karad |
School of Dental Sciences Department of Paedodontics room no 43 Krishna Vishwa Vidyapeeth Karad 415110 district Satara maharashtra India
Satara
MAHARASHTRA |
09405155367
mrunalpawar6397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee KVV Karad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
children whose parents have given consent for taking childs fingerprints
no underlying medical conditions
no history of penetrating trauma or burns
children with DMFT index more than 2
Childs behavior during treatment will be noted using Frankels behavior rating |
|
| ExclusionCriteria |
| Details |
children with no history of trauma and burns
chidren whose parents have not given consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study provides initial evidence suggesting an association between dermatoglyphics and dental caries and childs behavior during treatment in pediatric age group |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study provides initial evidence suggesting an association between dermatoglyphics & dental caries & childs behavior during treatment in pediatric age group |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Early childhood caries (ECC) poses a significant public health concern affecting the oral health of preschool-aged children While various risk factors have been studied the potential association between dermatoglyphics the study of fingerprint patterns and ECC remains relatively unexplored This research aims to investigate whether specific dermatoglyphic patterns are associated with an increased risk of ECC among preschoolers.association of dermatoglyphics with behaviour of children during restorative treatment in age group of 3-9 years will be done after getting consent from parents regarding taking fingerprints during first appointment of patient . |