| CTRI Number |
CTRI/2024/07/071415 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating the effectiveness in reduction of dental anxiety using animal therapy, soft toy and tell-show-do technique in the preventive dental procedure among 6 to 8 year old children. |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of
Distraction Therapy using Animal Assisted Therapy
Stuffed Toy Therapy and Conventional Tell-Show-Do in the Management of Dental Anxiety Amongst
6- to 8-Year-Old Children – A Randomized
Clinical Study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Doshi Raxit Vinodbhai |
| Designation |
Post Graduate student |
| Affiliation |
K.M Shah Dental College and Hospital |
| Address |
1 floor number 3 department of pediatric and preventive dentistry, K.M.Shah Dental College and Hospital, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
7600176313 |
| Fax |
|
| Email |
rakshitdoshi036@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Kariya |
| Designation |
Proffessor |
| Affiliation |
K.M. Shah dental college and hospital |
| Address |
1 floor number 3 department of pediatric and preventive dentistry, K.M. Shah dental college and hospital, Sumandeep vidyapeeth an deemed to be university, Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Kariya |
| Designation |
Proffessor |
| Affiliation |
K.M. Shah dental college and hospital |
| Address |
Pediatric and Preventive dentistry, K.M. Shah dental college and hospital, Sumandeep Vidyapeeth an deemed to be university, Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry, K.M.SHAH dental college and hospital, vadodara, gujarat |
|
|
Primary Sponsor
|
| Name |
Doshi Raxit Vinodbhai |
| Address |
23 SHREENATHJI VARNAN AAVA COUNTY WAGHODIA ROAD VADODARA - 391760 |
| 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 Raxit Vinodbhai Doshi |
K.M SHAH dental college and hospital |
1 floor, number 3, department of pediatric and preventive dentistry, K.M.SHAH dental college and hospital, sumandeep vidyapeeth an deemed to be university, vadodara, gujarat
Vadodara
GUJARAT |
7600176313
rakshitdoshi036@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics commitee |
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 |
| Intervention |
Animal Assited therapy |
therapy dog will be present while the procedure and anxiety will be assessed. |
| Intervention |
Stuffed toy therapy |
Patient will be given a soft of similar size of therapy dog. Pit and fissure sealant procedure in a single visit along with evaluation of dental anxiety will be done. |
| Comparator Agent |
Tell-Show-Do |
Patient will be explained each steps of treatment with the help of instrument and other study models in a single visit. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children between 6 and 8 years of age.
Children who are pet friendly.
Children requiring pit and fissure sealant dental procedure.
Frankl behavior rating scale category 3 and 4.
|
|
| ExclusionCriteria |
| Details |
Children with systemic or mental disorders.
Children with asthma and/or any known allergy.
Parents who do not give consent for their child to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Animal Assisted Therapy in pediatric patients at hospitals could offer a holistic approach to, address emotional, social, and cognitive needs, and contributing to the overall well-being and recovery of children facing dental procedures so through this study we will come to know how efficient AAT will be useful in reducing dental anxiety. |
anxiety score on day 1 and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there will be no difference animal assisted therapy and stuffed toy therapy is equal to tell-show-do method. There will be no difference in outcome |
anxiety score on day 1 and day 7 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
06/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
In Progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Animal Assisted Therapy with a therapy dog is a superior, safe, and non
pharmacological technique for managing dental anxiety in children aged 6-8 years. Its
effectiveness - particularly in highly anxious children - supports its integration into
routine pediatric dental practice with appropriate infection control protocols. |