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CTRI Number  CTRI/2022/10/046757 [Registered on: 25/10/2022] Trial Registered Prospectively
Last Modified On: 10/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Convenient Study 
Study Design  Other 
Public Title of Study   observation of behavioral changes of children under sedation for dental treatment  
Scientific Title of Study   Assessment of behavioral changes in children posted under sedation techniques for dental procedure.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSampreetha Somashekar  
Designation  Post graduate  
Affiliation  Coorg institute of dental sciences  
Address  Coorg institute of dental sciences kk campus magulla village virajpet coorg
Coorg institute of dental sciences Department no.8 kk campus magulla village virajpet coorg
Kodagu
KARNATAKA
571218
India 
Phone  9902140943  
Fax    
Email  sampreethasomashekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrShanthala BM  
Designation  Professor Head of the department  
Affiliation  COORG INSTITUTE OF DENTAL SCINCES 
Address  DEPARTMENT NO.8 COORG INSTITUTE OF DENTAL SCINCES KK CAMPUS MAGULLA VILLAGE VIRAJPETCOORG
DEPARTMENT NO.8 COORG INSTITUTE OF DENTAL SCINCES KK CAMPUS MAGULLA VILLAGE VIRAJPET COORG
Kodagu
KARNATAKA
571218
India 
Phone  9901452918  
Fax    
Email  shanthalapedo@cids.edu.in  
 
Details of Contact Person
Public Query  
Name  DrSampreetha Somashekar  
Designation  POST GRADUATE  
Affiliation  COORG INSTITUTE OF DENTAL SCINCES 
Address  DEPARTMENT NO.8 COORG INSTITUTE OF DENTAL SCINCES KK CAMPUS MAGULLA VILLAGE VIRAJPETCOORG
DEPARTMENT NO.8 COORG INSTITUTE OF DENTAL SCINCES KK CAMPUS MAGULLA VILLAGE VIRAJPET COORG
Kodagu
KARNATAKA
571218
India 
Phone  9902140943  
Fax    
Email  sampreethasomashekar@gmail.com  
 
Source of Monetary or Material Support  
COORG INSTITUTE OF DENTAL SCIENCES  
 
Primary Sponsor  
Name  DrSampreetha Somashekar  
Address  Coorg institute of dental sciences KK village magulla virajpet coorg  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   Not Applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSampreetha Somashekar   Coorg institute of dental sciences   Pedodontics department Room n0.8 Kanjithanda Kushalappa Campus,Magulla ,virajpet - 571218 Kodagu District ,Karnataka
Kodagu
KARNATAKA 		 9902140943

sampreethasomashekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient showing anxiety and fear towards dental treatment  
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1)Children with the age group of 5– 10 years
2)Children who are anxious, fearful and potentially
uncooperative towards the dental treat-ment
3)ASA I, II
 
 
ExclusionCriteria 
Details  1)Children with obstructed nasal airways
2)Children with any systemic illness
3)Children below 3 years with minimal communication
skills
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
if inhalation sedation affect behavioral changes before and after will be assed using statistics   in one and half years  
 
Secondary Outcome  
Outcome  TimePoints 
reduced dental anxiety and fear if inhalation sedation affect behavioral changes before and after will be assed using statistics   one and half years  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   03/11/2022 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dental environment and procedure can be anxious to the patients either adults or children. Increased anxiety is manifested in children aged five to ten as they are at various stages of emotional development. Behaviour changes are predominant in children on their visit to dental environment for the dental procedures. Behaviour changes in anxious young children’s pose threat to perform dental procedures in the dental environment and frequently they are posted under sedation technique.  
Sedation techniques generally for dental treatment is done by nitrous oxide alone or in combination with sedatives. The type of sedation used is determined by the child’s level of anxiety and the treatment rendered.  The various behavioural scale is available for assessment of anxiety and behaviour. The limited information on the use of specific scales for assessment of behavioural changes during sedation techniques initiated the present study to assess the level of behaviour changes that could occur in an anxious child treated under sedation techniques. 
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