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CTRI Number  CTRI/2023/12/060463 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 02/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effectiveness of Snake and Ladder Dental game on dental anxiety  
Scientific Title of Study   Effectiveness of Snake and ladder Dental game on Dental anxiety among 6 to 12 Year old children A Randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha M 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry 
Address  Room No:22, Department of Pediatric & Preventive Dentistry, Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9597651757  
Fax    
Email  kavitham@mgpgi.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Kavitha M 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry 
Address  Department of Pediatric & Preventive Dentistry, Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9597651757  
Fax    
Email  kavitham@mgpgi.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kavitha M 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry 
Address  Department of Pediatric & Preventive Dentistry, Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9597651757  
Fax    
Email  kavitham@mgpgi.edu.in  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, MGPGIDS 
 
Primary Sponsor  
Name  Kavitha M 
Address  MGPGIDS, Puducherry 
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 
Kavitha M  Dept of Pediatric & Preventive Dentistry,Mahatma Gandhi Post Graduate Institute of Dental Sciences  Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry
Pondicherry
PONDICHERRY 
9597651757

kavitham@mgpgi.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MGPGIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children undergoing dental procedures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  "Snake & ladder- Dental game”   The child will be taken to the play area initially where “Snake and ladder-Dental game” will be given to the children to play for 15 minutes before the treatment. The outcomes such as Anxiety level, Pulse rate and Oxygen saturation are measured at Baseline, 10 minutes of the procedure and 30 minutes of the procedure 
Comparator Agent  Control group  The child will be taken directly taken to the dental operatory for treatment. Anxiety level, Pulse rate, and oxygen saturation will be measured at Baseline, 10 minutes of the procedure and 30 minutes of the procedure  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children in the age group of 6 to 12 years reporting to the Department of Pediatric & Preventive dentistry MGPGIDS for dental treatment
Children willing to participate in the study
Children at first dental visit
 
 
ExclusionCriteria 
Details  Medically compromised children
Children with special health care needs
Children with severe pain and facial swelling and trauma
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anxiety level, pulse rate, oxygen saturation  Baseline, 10 mins, 30 mins 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="334"
Sample Size from India="334" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/12/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

Dental fear and anxiety is the most common and potentially distressing problem for both the patient and the dentist. Dental anxiety has been defined as an “abnormal fear or dread of visiting the dentist for preventive care or therapy and unwarranted anxiety over dental procedure. Dental anxiety during the procedure can have unwanted consequences, including uncontrollable behavior, lack of cooperation, and adverse psychological effects on the patients. It is important to control children’s behavior, gain their cooperation, and create a positive attitude about dental treatment. Due to the substantial effect of dental anxiety in pediatric patients, many pharmacological and non-pharmacological methods have been devised to alleviate or eliminate such anxieties of the patients. Due to the fondness for games in children, and also games are one such tool in reducing anxiety in children It has the found to be the most economical way to reduce anxiety in children needing dental treatments. Snake and ladder is an ancient game of India, originating in the Second century BC.  It was originally used by religious teachers to teach children about the vary between good and bad - climbing up the ladders represents good, and sliding down the snakes represents bad. In this Snake and Ladder- Dental game the child will be able to know both “the positive and negative habits “about oral health and also in reducing anxiety. Nowadays in this current era, parents introduce mobiles for distraction reducing anxiety in children and also in a few studies, the dentist uses mobile games for distraction and reducing anxiety.  The usage of smartphones and video games is harmful for children. Hence in this study, we planned to assess the Effectiveness of “Snake & ladder- Dental game”, an indigenous game on Dental anxiety among 6–12-Year-old children before and after dental treatment.

 
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