| CTRI Number |
CTRI/2025/07/090524 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Methods to Reduce Dental Anxiety in Children During Their First Dental Visit |
|
Scientific Title of Study
|
Comparison of the effectiveness of pre-treatment sensitization program and tell-show-do technique on dental anxiety of children undergoing dental treatment in their first dental visit– 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 |
Aurthi E |
| Designation |
Postgraduate |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, First floor, Old building, Indira Gandhi Institute of Dental Sciences, Pillayarkuppam, Puducherry 607402
Pondicherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
08870537500 |
| Fax |
|
| Email |
eaurthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanguida A |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, First floor, Old building, Indira Gandhi Institute of Dental Sciences, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY
605011
India |
| Phone |
8056105873 |
| Fax |
|
| Email |
sanguidaa@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Aurthi E |
| Designation |
Postgraduate |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, First floor, Old building, Indira Gandhi Institute of Dental Sciences, Pillayarkuppam, Puducherry 607402
Pondicherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
08870537500 |
| Fax |
|
| Email |
eaurthi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aurthi E |
| Address |
No.70, Om sakthi street,
Shanmugam Nagar,
Muthupillaipalayam ,
Pondicherry - 605 010 |
| 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 Aurthi E |
Indira Gandhi Institute of Dental Sciences |
Department of Pediatric and Preventive Dentistry,
First floor, Old building,
Indira Gandhi Institute of Dental Sciences,
Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY |
08870537500
eaurthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children between 4-6 years of age reporting to the department of pediatric and preventive dentistry requiring restorative treatment.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pre-treatment sensitization program |
Pre treatment sensitization program which is a pre – recorded validated video (working of dental chair, complete information about the equipment and dental procedure explained by the Principal investigator in Tamil, and child-friendly terms will be used (euphemism) ) just before the dental treatment in first dental visit. Children will be taken to dental operatory and restorative procedure will be performed. The duration of video is 3 minutes. |
| Comparator Agent |
Tell show do |
Children will be taken to dental operatory and then sensitized about the restorative procedure by the Standard Tell show do technique (TELL - verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done
SHOW - demonstration of the visual, auditory, and tactile aspect of the procedure, i.e. the child will be shown all the instruments and materials which are required for the treatment. DO – Without deviating from the explanation and demonstration the dentist proceeds directly to perform the previewed procedure ) for 2 minutes just before beginning the dental treatment |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 4-6 years of age, whose parents agreed to participate in the study.
2. Children with no history of preventive or therapeutic dental treatment
|
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs
2. Children with complaint of pain or who require emergency dental treatments
|
|
|
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 |
Change in anxiety levels as measured by
- Physiological measures
- Anxiety scales |
Pre treatment and Post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
22/07/2025 |
| 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="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
|
Children between 4 to 6 years of age reporting to the department of pediatric and preventive dentistry of Indira Gandhi Institute of Dental Sciences will be selected based on the inclusion and exclusion criteria. Randomisation will be done by computer generated numbers.Participants will be randomly assigned to two groups:
-
Group 1 (Pre-treatment sensitization program): Children will watch a pre-recorded video explaining dental procedures in child-friendly language, followed by restorative treatment.
-
Group 2 (Tell-Show-Do technique): Children will receive a verbal explanation, a demonstration of dental instruments, and then the procedure will proceed as described.
Anxiety and pulse rates will be recorded during the procedure by a blinded observer. Data will be analyzed to assess the effects of each technique on anxiety and pulse rate. |