| CTRI Number |
CTRI/2024/04/065035 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
It is a study between fingerprints, length of index and ring finger ratio and body mass index to find their relation with dental caries in 6-12 years old children. |
|
Scientific Title of Study
|
Association between Dactyloscopy, Hormonal fingerprints (2D:4D ratio) and BMI in predicting dental caries in children of age 6-12 years old –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 |
RISHIKESH KUMAR |
| Designation |
MDS 2ND YEAR |
| Affiliation |
MAHARISHI MARKANDEHWAR COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no.-04,Pediatric and preventive dentistry, Maharishi Markandeshwar college of dental sciences and research,Maharishi Markandeshwar deemed to be university, Mullana
Ambala
HARYANA
133207
India |
| Phone |
6206582298 |
| Fax |
|
| Email |
rishikeshkumar49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.HP SUMA SOGI |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
MAHARISHI MARKANDEHWAR COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no.-04,Pediatric and preventive dentistry, Maharishi Markandeshwar college of dental sciences and research,Maharishi Markandeshwar deemed to be university, Mullana
Ambala
HARYANA
133207
India |
| Phone |
6206582298 |
| Fax |
|
| Email |
hpsumasogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RISHIKESH KUMAR |
| Designation |
MDS 2ND YEAR |
| Affiliation |
MAHARISHI MARKANDEHWAR COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
Room no.-04,Pediatric and preventive dentistry, Maharishi Markandeshwar college of dental sciences and research,Maharishi Markandeshwar deemed to be university, Mullana
Ambala
HARYANA
133207
India |
| Phone |
6206582298 |
| Fax |
|
| Email |
rishikeshkumar49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.-04,Pediatric and preventive dentistry, Maharishi Markandeshwar college of dental sciences and research,Maharishi Markandeshwar deemed to be university, Mullana |
|
|
Primary Sponsor
|
| Name |
DR RISHIKESH KUMNAR |
| Address |
Room no.-04,Pediatric and preventive dentistry, Maharishi Markandeshwar college of dental sciences and research, Maharishi Markandeshwar deemed to be university, Mullana |
| 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 RISHIKESH KUMAR |
Room no.-04,Pediatric and preventive dentistry |
Maharishi Markandeshwar college of dental sciences and research,Maharishi Markandeshwar deemed to be university, Mullana
Ambala
HARYANA |
6206582298
rishikeshkumar49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,MM INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, MULLANA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children belonging to age group of 6-12 years.
Children not under any caries preventive programme.
|
|
| ExclusionCriteria |
| Details |
Children undergoing orthodontics therapy.
Children with deformed ridges and prosthetic replacement of fingers.
Children with cleft lip and cleft palate.
Children with congenitally missing teeth.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a significant correlation between hormonal fingerprints, body mass index and dactyloscopy with Dental Caries. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be a significant correlation between hormonal fingerprints, body mass index & dactyloscopy with Dental Caries. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="294"
Sample Size from India="294"
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)
|
15/04/2024 |
| 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="2"
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
|
The study will be conducted on the patients reporting to the department of Pediatric and preventive dentistry, MMCDSR,MMDU,Mullana.Allocated no. of patients for this study will be 294 by using inclusion and exclusion criteria. After getting informed consent from the parents the clinical procedure will be carried out. For this study impression of right palm will be taken using ink stamp pad on a white sheet, measurement of the index and ring finger will be done using digital vernier calliper. For BMI, weight will be calculated using weighing machine and height will be calculated using measuring scale. Then DMFT/DEFT will be calculated. The whole study is done to find relationship between fingerprints, ratio of index and ring finger and BMI |