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CTRI Number  CTRI/2025/02/081375 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Which is better in reducing dental anxiety among Tell play do with smart phone digital dentist game and Stress ball in children aged 6-10 years 
Scientific Title of Study   Comparative evaluation of Tell play do with smart phone digital dentist game and Stress ball in reducing anxiety in children aged 6-10 years: 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  Dr Chetan Zinzala 
Designation  Post Graduate Student 
Affiliation  College of Dental Sciences, Amargadh, Bhavnagar, Gujarat 
Address  Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar,Gujarat,364210,India

Bhavnagar
GUJARAT
364210
India 
Phone  8153887596  
Fax    
Email  chetan.zinzala1305@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram Jhamb 
Designation  Professor Of The Department in Pediatric and Preventive Dentistry 
Affiliation  College of Dental Sciences, Amargadh, Bhavnagar, Gujarat 
Address  Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar, Gujarat,364210,India

Bhavnagar
GUJARAT
364210
India 
Phone  9620159058  
Fax    
Email  dr.vikramjhamb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Jhamb 
Designation  Professor Of The Department in Pediatric and Preventive Dentistry 
Affiliation  College of Dental Sciences, Amargadh, Bhavnagar, Gujarat 
Address  Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar, Gujarat,364210,India

Bhavnagar
GUJARAT
364210
India 
Phone  9620159058  
Fax    
Email  dr.vikramjhamb@gmail.com  
 
Source of Monetary or Material Support  
College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat 
 
Primary Sponsor  
Name  College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat 
Address  Department of pediatric and preventive dentistry,division P, Room no.6, College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat-364210 
Type of Sponsor  Private medical college 
 
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 Chetan Zinzala  College of Dental Sciences, Amargadh, Bhavnagar, Gujarat  Department of pediatric and preventive dentistry,division P, Room no.6, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat-364210
Bhavnagar
GUJARAT 
8153887596

chetan.zinzala1305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A (control group):Tell show do technique  Tell show do technique will be used to reduce dental anxiety level.In this group, verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done. After the explanation, demonstration of the visual, auditory, and tactile aspects of the procedure will be given to the child. The child will be shown all the instruments and materials required for the treatment, and the child will be made aware of the airotor noise. The child will also be shown how the airotor, three-way syringe, and suction work. Afterward, the child will be taken for the treatment, and the restorative procedure will be performed. This control group will take 25-30 minutes to assess anxiety before, during and after the treatment. 
Intervention  Group B (experimental group 1) : Tell play do with smart phone digital dentist game   Tell play do with smart phone digital dentist game will be used. In this technique, children will play a dentist game on a smartphone (Baby Panda Dental Care game) to learn about dental tools in a fun way for 5-10 minutes before starting the procedure. I will explain to the child everything that is shown in the game and participate in the activity by playing the game with the child to educate them about the dental treatment procedures, such as restorations, that will be performed on them. After that, the procedure will be started. This games ability to combine education with entertainment, along with its proven popularity and positive feedback from parents, makes it the most suitable choice for my study. Its rating is also better compared to other dentist games on the Play Store. This intervention will take 25-30 minutes to assess anxiety before, during and after the treatment. 
Intervention  Group C (experimental group 2): Stress ball  Stress ball will be used.In this technique we will have 3 sizes (small,medium,large) of squeeze ball which will be shown to the children so they can choose one according to their comfort and before conducting the procedure children will be instructed to squeeze the ball for 5-10 minutes and after that procedure will be started. This intervention will take 25-30 minutes to assess anxiety before, during and after the treatment. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Children in the age range of 6-10 years.
2. Children of both sexes.
3. Class I carious lesion on the primary molars who requiring a restoration without local anesthesia. 
 
ExclusionCriteria 
Details  1.Children with special health care needs.
(Physically and mentally challenged).
2.Parents of children who refuse to give consent.
3.Extensively damaged teeth.
4.Teeth with lesions involving pulp. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess children anxiety  Before, During and After the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in dental anxiety  Variation of pulse measured using pulse oximeter before, during and after the procedure 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   18/08/2025 
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  

A randomized controlled trial will be carried out on 180 children aged 6-10 years who will be reporting to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat  indicated for the treatment of class I restoration.Written informed consent will be taken before conducting the study. 

A total of 180 children will be taken for the study which will be divided in to 3 different groups.

 60 children will be allocated to each group which will be divided in to:

 

Group A (control group):Tell  show do technique

 

Group B (experimental group 1) : Tell play do with smart phone digital dentist game

 

Group C (experimental group 2): Stress ball

 

Group A (control group):Tell  show do technique will be used to reduce dental anxiety level.In this group, verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done. After the explanation, demonstration of the visual, auditory, and tactile aspects of the procedure will be given to the child. The child will be shown all the instruments and materials required for the treatment, and the child will be made aware of the airotor noise. The child will also be shown how the airotor, three-way syringe, and suction work. Afterward, the child will be taken for the treatment, and the restorative procedure will be performed.

 

Group B (experimental group 1) : Tell play do with smart phone digital dentist game will be used. In this technique, children will play a dentist game on a smartphone (Baby Panda Dental Care game) to learn about dental tools in a fun way for 5-10 minutes before starting the procedure. I will explain to the child everything that is shown in the game and  participate in the activity by playing the game with the child to educate them about the dental treatment procedures, such as restorations, that will be performed on them. After that, the procedure will be started. This game’s ability to combine education with entertainment, along with its proven popularity and positive feedback from parents, makes it the most suitable choice for my study. Its rating is also better compared to other dentist games on the Play Store.

Group C (experimental group 2): Stress ball will be used.In this technique we will have 3 sizes (small,medium,large) of squeeze ball which will be shown to the children so they can choose one according to their comfort and before conducting the procedure children will be instructed to squeeze the ball for 5-10 minutes and after that procedure will be started.

Samples in each group will be treated in a single appointment after using either of the behaviour modification techniques.Class I cavities will be prepared on carious primary molar and will be restored using Glass ionomer cement.

This study is designed as a single blind (participants), randomized controlled trial with two parallel groups.  Samples will be randomly allocated to the study groups by simple randomization by lottery method for equal distribution of sample size in study group.    

 

In this study Anxiety of the subject will be assesed before,during (immediately after cavity preparation) and after the treatment objectively by pulse rate with the help of pulse oximeter (by DR VAKU) and subjectively by chotta bheem chutki scale in all the three groups.

CBC scale is a newly designed scale. This scale comprises two separate cards; one for boys and the other for girls.For boys, the Chotta Bheem cartoon character will be chosen to depict various emotions, and for girls, the Chutki cartoon character will be chosen to depict various emotions. Each card will consist of a series of six figures, ranging from happy to unhappy, with the cartoon character displaying different emotions. Children will be asked to choose the face they identify with at that moment. To record on the scale, a score of one will be assigned to the happy face, and six will be assigned to running.

 
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