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CTRI Number  CTRI/2023/05/053163 [Registered on: 26/05/2023] Trial Registered Prospectively
Last Modified On: 24/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   ASSOCIATION OF FINGERPRINT PATTERNS WITH ORAL HEALTH STATUS OF SPECIAL SCHOOL CHILDREN IN MANGALORE CITY 
Scientific Title of Study   ASSOCIATION OF DERMATOGLYPHIC PATTERNS WITH ORAL HEALTH STATUS OF SENSORY IMPAIRED SCHOOL CHILDREN IN MANGALORE CITY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAGUN AGGARWAL 
Designation  POST GRADUATE 
Affiliation  AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7009718105  
Fax    
Email  sagunagg27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SRIKALA BHANDARY 
Designation  ADDITIONAL PROFESSOR 
Affiliation  AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9535620371  
Fax    
Email  drsrikalabhandary@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  DR SRIKALA BHANDARY 
Designation  ADDITIONAL PROFESSOR 
Affiliation  AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9535620371  
Fax    
Email  drsrikalabhandary@nitte.edu.in  
 
Source of Monetary or Material Support  
DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 
 
Primary Sponsor  
Name  SAGUN AGGARWAL 
Address  ROOM NO:15 , 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SAGUN AGGARWAL  A B SHETTY MEMORIAL OF INSTITIUTE OF DENTAL SCIENCES  DOOR NO: 15 . FOURTH FLOOR , DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETRTY MEMORIAL INSTITUTE OF DENTAL SCIENCES , DAKHINA KANNADA Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 		 7009718105

sagunagg27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, A B SHETTY MEMORIAL INSITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q169||Congenital malformation of ear causing impairment of hearing, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1) Sensory impaired children including visually impaired, speech and hearing impaired children with caries (ICDAS 2-6) and without caries.
2) Normal healthy children with caries (ICDAS 2-6) and without caries.
3) Children who are willing to participate in the study with parental consent.
 
 
ExclusionCriteria 
Details  1) Children with skin disorders, trauma to the fingertips, and uncooperative children.
2) Children having any other sensory impairment except visual, hearing and speech impairment.
3) Children without parental consent.
4) Medically compromised children.
5) Children who are severely ill and cannot be examined.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the association of dermatoglyphic patterns with oral health status of sensory impaired children   9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare dermatoglyphic patterns and oral health status between sensory impaired and normal healthy children.  18 months 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   01/06/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   MOT APPICABLE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Dermatoglyphics is the “study of dermal ridge patterns on volar surfaces of fingers, palms, and soles."  Dental caries has multiple interlinked etiopathological components, and its relationship with epidermal ridges is explained by the fact that the teeth and dermal ridges develop from same germ layer ectoderm during the same time of 6th to 7th week of intrauterine life. It contains genetic information which are interrelated, and any disturbance seen during this period reflects on each other. Various studies have found a positive correlation between dermal patterns and caries in children, but no research has been done in children with sensory impairments.  This emphasizes on the importance to explore more on the relationship between dermatoglyphics, dental caries and oral hygiene status of these children .

A total of 144 children aged between 8-15 years of either sex including visually impaired, hearing and speech impaired children, and normal healthy children, from various special and regular schools in Mangalore city will be included in the study.

The selected children will be divided into case group (96 sensory impaired children) and control group (48 normal healthy children).

Case group will be divided into two groups:

Group A: 48 visually impaired children, and

Group B: 48 hearing and speech impaired children

Control group:  48 normal healthy children.

Each group will be subdivided into caries and caries free group (24 children in every group).

Dermatoglyphic patterns of both hands will be recorded using the Cummins and Mildo method.

Oral Health Status will be recorded using World Health Organization Oral Health Assessment Form for Children, 2013.

 Caries experience will be recorded using the International Caries Detection and Assessment System (ICDAS) criteria (2015).
Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS (Statistical Package for Social Sciences) analysis software (version 23). 
 
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