| CTRI Number |
CTRI/2025/04/084134 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Anxiety Reduction Methods in Children Before Dental Procedures Tell-Show-Do versus Therapeutic Toy |
|
Scientific Title of Study
|
Comparison of anxiety reduction using tell-show-do technique and therapeutic toy for behaviour modification prior to dental restorative procedure in 6–10-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 |
Dr Anam Shaikh |
| Designation |
Post graduate student (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Department of Pediatric and Preventive Dentistry |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
7710810858 |
| Fax |
|
| Email |
dranam158@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvi Saraf |
| Designation |
Guide and Associate professor of Department of Pediatric and Preventive Dentistry |
| Affiliation |
Department of Pediatric and Preventive Dentistry |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
9819114395 |
| Fax |
|
| Email |
drsaraftanvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anam Shaikh |
| Designation |
Post graduate student (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Department of Pediatric and Preventive Dentistry |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
7710810858 |
| Fax |
|
| Email |
dranam158@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Anam Shaikh |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anam Shaikh |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital |
Department of Pediatric and Preventive Dentistry
Sector 7 CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA |
7710810858
dranam158@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tell Show Do (TSD) |
The child will be introduced to the restorative procedure with the help of dental instruments and an acrylic model. In a hierarchy of anxiety provoking situation from least feared (use of hand instruments to create cavity) to the feel of air rotor on the palm of the child to the most feared (use of air rotor) will be demonstrated on the dental model.
Thus the entire dental restorative procedure will be explained with the use of euphemisms and complete involvement of the child with the primary investigator. |
| Intervention |
Therapeutic Toy (TT) |
Therapeutic toy simple component play in which the child performs the treatment on the model using simulating dental instruments
The child will be introduced to the restorative procedure with the help of pretend dental instruments and a therapeutic toy.
The child will be asked to assume the role of a dentist and the therapeutic toy will be the patient
In a hierarchy of anxiety provoking situation, the primary investigator will direct the child to conduct from least feared (use of pretend hand instruments to create cavity) to the feel of pretend air rotor on the palm of the child to the most feared(use of pretend air rotor) will be conducted on the toy.
Thus the entire dental restorative procedure will be explained with sound to mimic the sound and hand movements to mimic the vibrations of the of air rotor along with the use of euphemisms. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to 10 year old.
2. Physically and mentally fit children.
3. Dental caries with a localized enamel breakdown without clinical signs of dentinal involvement requiring restorations without local anaesthesia.
4. Children whose parents will give written consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Children who might need the administration of local anesthesia while doing the treatment.
2. Those in need of emergency dental attention (pain, swelling, trauma, etc.) will be excluded from the study.
3. If the child requires any pharmacological behaviour management technique. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess anxiety of the child before the appointment through a pre-test questionnaire answered by the parent.
2. To assess anxiety of the child at the next appointment through a post-test questionnaire answered by parent.
3. To compare the change in pre-test and post-test anxiety levels of the child.
4. To compare the change in anxiety levels of pre-test between Group A (TSD) and Group B (TT).
5. To compare the change in anxiety levels of post-test between Group A (TSD) and Group B (TT).
|
1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent.
2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess knowledge of the child before the appointment through a pre-test questionnaire answered by the parent.
2. To assess knowledge of the parent before the appointment through a pre-test questionnaire.
3. To assess knowledge of the child at the next appointment through a post-test questionnaire answered by parent.
4. To assess knowledge of the parent before the next appointment through a post-test questionnaire.
5. To compare the change in pre-test and post-test knowledge levels of the child.
6.To compare the change in pre-test and post-test knowledge levels of the parent. |
1. On the day of the appointment- a pre-test on the knowledge of the parent will also be assessed.
2. Within 7 days of the first appointment- a post-test on the knowledge of the parent will also be assessed.
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Background:
Dental anxiety in children can lead to uncooperative behavior, making dental procedures challenging. Effective behavior management techniques, such as the Tell-Show-Do (TSD) method, help familiarize children with procedures through explanation and demonstration, reducing fear. Therapeutic toys offer an alternative approach by providing distraction and emotional comfort. However, there is limited research comparing their effectiveness in managing pre-procedural anxiety. Purpose:
This randomized controlled trial aims to evaluate and compare the impact of the Tell-Show-Do technique and therapeutic toys in reducing anxiety in 6 to 10 year old children before and after dental restorative procedures. The study seeks to identify the more effective method in improving cooperation and enhancing the overall dental experience. |