| CTRI Number |
CTRI/2025/07/089917 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out if fingerprint patterns are different in children who behave well and those who don’t during dental visits |
|
Scientific Title of Study
|
Assessment of digital dermatoglyphic pattern variation between children exhibiting cooperative and uncooperative behavior in the dental operatory |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shepali Hule |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of pediatric and preventive dentistry, Sharad Pawar dental college and hospital ,Sawangi,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09987814896 |
| Fax |
|
| Email |
shepalihule3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramakrishna Yeluri |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of pediatric and preventive dentistry, Sharad Pawar dental college and hospital ,Sawangi,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9997951558 |
| Fax |
|
| Email |
drramakrishnay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramakrishna Yeluri |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of pediatric and preventive dentistry, Sharad Pawar dental college and hospital ,Sawangi,Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9997951558 |
| Fax |
|
| Email |
drramakrishnay@gmail.com |
|
|
Source of Monetary or Material Support
|
| sharad pawar dental college and hospital, sawangi meghe, wardha, maharashtra pincode-442001 |
|
|
Primary Sponsor
|
| Name |
Shepali Hule |
| Address |
Department of pediatric and preventive dentistry, Sharad pawar dental college and hospital, sawangi, wardha. pincode- 442001 |
| 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 SHEPALI HULE |
Sharad pawar dental college and hospital |
302/Department of pediatric and preventive dentistry, Sharad Pawar dental college and hospital ,Sawangi,Wardha
Wardha
MAHARASHTRA |
09987814896
shepalihule3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F39||Unspecified mood [affective] disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. cooperative group
2. Uncooperative group |
Children meeting the inclusion criteria will be selected after obtaining informed parental consent. An oral examination will be conducted in the presence of a parent, during which the childs behavior will be assessed using the Frankl Behavior Rating Scale. Based on the scale, children will be categorized as cooperative or uncooperative. Fingerprints will then be collected using a digital scanner and classified into loop, whorl, or arch patterns using Cummins’ method. Each fingerprint will be analyzed twice for accuracy, with discrepancies resolved by a blinded, calibrated examiner. Data will be recorded in Excel and statistically analyzed using IBM SPSS version 23. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Parent’s consent to participate in the study
2. No previous dental experience or treatment
|
|
| ExclusionCriteria |
| Details |
History of medical, congenital, psychological and mental disorders.
History of penetrating trauma or burning that may have changed the dermatoglyphic pattern.
Children who have any skin disorder on their fingers where it is impossible to take fingerprints.
4. Children having oral habits like thumb sucking or digit sucking or nail biting that may affect fingerprints.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between fingerprint patterns -loop, whorl, arch and children’s behavior in cooperative or uncooperative during dental treatment. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will examine how specific fingerprint patterns are distributed among cooperative and uncooperative children. It will also evaluate the potential of dermatoglyphics as a non-invasive tool to predict behavior during dental visits and validate the effectiveness of Frankl’s Behavior Rating Scale in assessing dental behavior. |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/08/2025 |
| 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="0"
Months="6"
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
|
The proposed study titled “Assessment of digital dermatoglyphic pattern variation between children exhibiting cooperative and uncooperative behaviour in the dental operatory” aims to explore the potential link between fingerprint patterns and children’s behavior during dental treatment. Children’s cooperation plays a critical role in pediatric dentistry, influencing the ease and success of dental procedures. Dermatoglyphics, the study of fingerprint patterns, which are unique, genetically determined, and formed during early fetal development, may serve as a non-invasive tool to predict behavioral tendencies. This study will involve children aged 4–8 years visiting the dental clinic for the first time. Their behavior during oral examination will be assessed using Frankl’s behavior rating scale, and fingerprints will be collected using a digital scanner. The patterns—loop, whorl, and arch—will be classified and analyzed for any correlation with their cooperative or uncooperative behavior. If a reliable association is found, dermatoglyphics could serve as a simple, cost-effective method to anticipate behavior and help in planning appropriate behavior management strategies, especially in regions like Wardha, Maharashtra, where such studies have not been previously conducted. |