| CTRI Number |
CTRI/2021/06/033964 [Registered on: 03/06/2021] Trial Registered Prospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of the relationship between thumbprints and spacing in teeth among children aged 3-6 years. |
|
Scientific Title of Study
|
Assessment of the Relationship Between Dermatoglyphics and Spaced- Non spaced Dentition Among Children Aged 3-6 Years: A cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreyas Shahid |
| Designation |
PG Student |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS |
| Address |
Manav Rachna Dental College, Faculty of dental Sciences, MRIIRS,
Sector 43, Delhi Surajkund- Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9975067256 |
| Fax |
|
| Email |
sshahid1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shveta Sood |
| Designation |
Head of Department |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS |
| Address |
Department of Pediatrics and Preventive dentistry, Manav Rachna Dental college, faculty of Dental sciences, MRIIRS, Sector 43, Delhi Surajkund- Badhkal Road
Faridabad
HARYANA
121004
India |
| Phone |
9899000839 |
| Fax |
|
| Email |
shvetasood.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreyas Shahid |
| Designation |
PG Student |
| Affiliation |
Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS |
| Address |
Manav Rachna Dental College, Faculty of dental Sciences, MRIIRS,
Sector 43, Delhi Surajkund- Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9975067256 |
| Fax |
|
| Email |
sshahid1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Faculty of Dental Science, MRIIRS |
|
|
Primary Sponsor
|
| Name |
Dr Shreyas Shahid |
| Address |
Manav Rachna Dental College, faculty of dental Sciences, MRIIRS, Sector – 43,Delhi- Suraj Kund Badkhal Road, Faridabad, Haryana. 121004 |
| 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 Shreyas Shahid |
Manav Rachna Dental College |
Faculty of Dental Sciences, MRIIRS, Sector – 43,Delhi-Suraj Kund Badkhal Road, Faridabad, Haryana. 121004
Faridabad
HARYANA |
9975067256
sshahid1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 3-6 years
2.Complete set of erupted primary teeth
|
|
| ExclusionCriteria |
| Details |
1.Absence of a thumb digit.
2.Patient having known oral habit.
3.Patient with conditions/abnormities that did not allow accurate recording of fingerprints.
4.Patients with class II, III, IV caries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find a relationship between the recorded thumbprints of the children aged 3 to 6 years with the recorded spacing in their mouth.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate how different types of thumbprint ridge patterns will affect the spacing found in the dentition of the children aged 3 to 6 years. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
07/06/2021 |
| 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="1"
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
|
The aim of the study is to analyze and correlate the recorded thumbprints of the children with the recorded spacing in the mouth. 320 children of age group 3 to 6 years will be chosen. the intraoral photographs will be taken using a digital camera to assess the spacing in the dentition. Ridge pattern of the thumbs will be recorded using a digital fingerprint scanner. Finally, statistical analysis will be done to correlate dermatoglyphics with the incidence of spaced or non spaced dentition. |