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CTRI Number  CTRI/2024/08/071878 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Determining the relation between fingerprint patterns and salivary enzyme levels and childs behavior in a dental setting. 
Scientific Title of Study   Determining the correlation between dermatoglyphic patterns, salivary alpha-amylase (sAA) levels and childs behavior in a dental setting - 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  Deepthi Nirmal Gavarraju 
Designation  Reader 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room No-7, Department of Pediatric and Preventive Dentistry, Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9491560596  
Fax  863-2292149  
Email  drdeepthipedo@sids.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  A J Sai Sankar 
Designation  Professor and head of the department 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room No-7, Department of Pediatric and Preventive Dentistry, Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9346550646  
Fax    
Email  drsaisidspedo@sids.ac.in  
 
Details of Contact Person
Public Query
 
Name  A J Sai Sankar 
Designation  Professor and head of the department 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room No-7, Department of Pediatric and Preventive Dentistry, Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9346550646  
Fax    
Email  drsaisidspedo@sids.ac.in  
 
Source of Monetary or Material Support  
Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh, India PIN-522509 
 
Primary Sponsor  
Name  Deepthi Nirmal Gavarraju 
Address  Room No-7, Department of pediatric and preventive dentistry, Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh, 522509. 
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 Deepthi Nirmal Gavarraju  Sibar institute of dental sciences  Room No-7, 2nd floor, Department of pediatric and preventive dentistry
Guntur
ANDHRA PRADESH 
9491560596

drdeepthipedo@sids.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sibar institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K119||Disease of salivary gland, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  saliva sample collection  2 ml of saliva is collected before and after any dental treatment procedure (30 minutes duration) for analysis of salivary alpha amylase enzyme levels.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Healthy children
First dental visit or No previous dental experience
 
 
ExclusionCriteria 
Details  1.Children with special healthcare needs.
2.History of penetrating trauma or burns that might affect the dermatoglyphic pattern of the palms and digits.
3.Children with missing digits.
4.Children with conditions or abnormalities that may not allow accurate recording of fingerprints.
5.Patients who are under any medication that could affect salivary gland function.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
By identifying predictive markers of stress and anxiety, dental practitioners can better anticipate and manage behavioral challenges, leading to more effective and less traumatic dental care for the child.   baseline and after treatment procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Development of personalized approaches to pediatric dental treatment; enhancing patient co-operation, reducing the need for sedation or restraint and ultimately improving the overall dental experience.  baseline and after treatment procedure 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   31/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

TITLE: Determining the correlation between dermatoglyphic patterns, salivary alpha-amylase (sAA) levels, and child’s behavior in a dental setting.

PRINCIPAL INVESTIGATOR: Dr.Deepthi Nirmal Gavarraju

DESIGNATION: Reader, Department of pediatric and preventive dentistry, Sibar institute of dental sciences, Guntur.

EMAIL: drdeepthipedo@sids.ac.in

PHONE NUMBER: 9491560596


INTRODUCTION:

Pediatric dentistry revolves around the premise of assessing the behavior and reactions of children as every child develops emotionally and mentally at different rates causing varied reactions to the same modalities This behavior of the child in a dental setup is influenced by environmental factors such as the outlook of the operatory, the doctor’s attire and attitude and by genetic factors.

 

The interplay between physiological markers, genetic traits, and behavioral responses in pediatric dental settings is a multifaceted and underexplored area of research. According to developmental biology, dermal ridge development is timed to match that of the neocortex. As a result, fingerprints or dermal ridge patterns may be used to determine children’s behavior.

 

Recent years have shown an increasing interest in salivary alpha amylase (sAA) as a noninvasive marker for sympathetic nervous system activity which reflects fear in a person. sAA, an enzyme linked to stress responses, can provide insight into the physiological stress levels of children in potentially anxiety-inducing situations. By understanding how these biological markers correlate with behavioral responses, this research seeks to enhance the ability of dental practitioners to predict and manage the children’s behavior during dental treatment procedures.

 

AIM:

To determine the correlation between dermatoglyphic patterns, salivary alpha-amylase (sAA) levels and child’s behavior in a dental setting.

 

OBJECTIVES:

-          To determine the dermatoglyphic patterns of the study subjects.

-          To determine the salivary alpha-amylase (sAA) levels of the subjects before and during the treatment.

-          To determine the behavior of the study subjects before and during the treatment.

-          To establish co-relation between the fingerprint patterns, salivary alpha-amylase (sAA) levels, and the behavior of children in a dental setting.

Reasons to choose the proposed research:

 The study integrates genetic, physiological and behavioral data in a novel way, exploring correlations that have been minimally researched. This multidisciplinary approach could uncover new insights into the predictors of pediatric dental behavior.

 

METHODOLOGY:

                                           

Sample size determination:

Sample size estimated by G* power version 3.1.9.4 software.

The following parameters are used to determine the sample size –

Effect size – 0.3

Alpha error probability – 0.05

Power – 90%

Total sample size obtained is 112 which will be rounded off to 120 for convenience.

 

Sample selection:

Children age ranging from 6-9 years without gender discrimination visiting as out patients to the department of pediatric and preventive dentistry in a dental institute will be selected based on the following criteria:

 

Inclusion Criteria:

• Healthy children

• First dental visit / No previous dental experience

 

Exclusion Criteria:

·         Children with special healthcare needs.

·         History of penetrating trauma or burns that might affect the dermatoglyphic pattern of the palms and digits.

·         Children with missing digits.

·         Children with conditions/abnormalities that may not allow accurate recording of fingerprints.

·        Patients who are under any medication that could affect salivary gland function.

 

Patients and Methodology:

The study will be explained to the parents/patient and informed consent will be obtained before proceeding with the study.

·         Recording of behavior:

Behavior of child will be assessed by the principal investigator using Frankl’s Behaviour Rating Scale before and during any treatment procedure.

·        Saliva collection:

Saliva samples will be collected at two different time intervals- before and after the dental procedure. Saliva samples will be collected using the “spitting method”. Each subject will be asked to rinse their mouth with water to reduce contamination of saliva with food debris prior to sampling. Whole mouth saliva from the oral cavity will be collected by asking the subjects to sit comfortably in an upright position with their heads down. Atleast 2 ml of saliva which accumulates in the floor of the mouth will be collected into a graduated polypropylene test tube. After collection, the unprocessed samples will be stored at -20°C. Salivary alpha-amylase will be measured by a colorimetric assay using 4,6-ethylidene-(G7)p-nitrophenyl-(G1)-D-maltoheptaoside (ethylidene-G7PNP) in an automatic analyser.

·        Recording of fingerprint:

After receiving assent from the study subject, finger prints of both left and right hands will be recorded using a digital fingerprint scanner attached to a computer system and the images will be immediately transferred into storage data. The assessment of the recorded fingerprints will be done using Cummins method of fingerprint identification.

 

 EXPECTED OUTCOMES AND CLINICAL RELEVANCE:

By identifying predictive markers of stress and anxiety, dental practitioners can better anticipate and manage behavioral challenges, leading to more effective and less traumatic dental care for the child. It can also lead to the development of personalized approaches to pediatric dental treatment; enhancing patient co-operation, reducing the need for sedation or restraint and ultimately improving the overall dental experience.

 
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