| CTRI Number |
CTRI/2025/07/090402 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing and evaluating sensory adapted dental environment and regular dental environment |
|
Scientific Title of Study
|
Comparing and evaluating the behavioral changes and anxiety in sensory adapted dental environment (SADE) and regular dental environment (RDE) on 6-8 years aged children: a randomized control cross over 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 |
Neha Tapdiya |
| Designation |
Post graduate student |
| Affiliation |
Ranjeet Deshmukh Dental college and research centre |
| Address |
Ranjeet Deshmukh Dental College and research Centre, Digdoh hills, Nagpur
Nagpur
MAHARASHTRA
440016
India |
| Phone |
07218274968 |
| Fax |
|
| Email |
nehatapdiya190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Purva Chaudhari |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental college and research centre |
| Address |
Ranjeet Deshmukh Dental College and research Centre, Digdoh hills, Nagpur
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8600604340 |
| Fax |
|
| Email |
purvachowdhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Purva Chaudhari |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
Ranjeet Deshmukh Dental College and research Centre, Digdoh hills, Nagpur
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8600604340 |
| Fax |
|
| Email |
purvachowdhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Hingna road, Digdoh hills, Police nagar, Nagpur, Maharashtra, India Pincode-440016 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and research Centre |
| Address |
Ranjeet Deshmukh Dental College and research Centre, Digdoh hills, Police nagar, Nagpur |
| Type of Sponsor |
Private medical college |
|
|
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 Neha Tapdiya |
Ranjeet Deshmukh Dental College and Research Centre |
Department of Pediatric and Preventive Dentistry
Nagpur
MAHARASHTRA |
07218274968
nehatapdiya190@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
REGULAR DENTAL ENVIRONMENT |
Regular dental settings are often associated with unsettling environments characterized by strong smells, bright lights, and the whirring sounds of dental equipment. For individuals who are sensitive to certain stimuli, these factors can be particularly distressing. Such an environment can increase stress, create anxiety about dental visits, and even lead to delays in seeking or undergoing necessary treatments. |
| Intervention |
SENSORY ADAPTED DENTAL ENVIRONMENT |
The Snoezelen environment is a multisensory, patient-centered therapeutic approach designed to improve the well-being of individuals experiencing anxiety, pain, or discomfort. It aims to enhance the quality of life for various populations by providing a calming, sensory-rich experience. The physical setup typically includes a dimly lit room with special lighting effects or moving visuals, soothing music, pleasant aromas and deep pressure effect, all carefully chosen to create a relaxing and peaceful atmosphere that promotes relaxation and emotional comfort. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
children having Frankel behavior rating score 2,3,4 requiring two setting for restoration of teeth with ICDSA score 3,4 and 5. |
|
| ExclusionCriteria |
| Details |
Children with severe caries that may involve the pulp and Children with hearing loss, vision loss and olfactory disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare behavioral changes of 6-8 years aged children in sensory adapted dental environment and regular dental environment via Venham’s behavioral rating scale.
2.To evaluate and compare anxiety of 6-8 years aged children in sensory adapted dental environment and regular dental environment via Venham’s clinical anxiety scale. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the acceptance of Sensory adapted dental environment in children aged 6-8 years. |
After the 2nd treatment visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
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
|
The purpose of the present study is to evaluate
and compare behavioral and physiological effect in a sensory adapted dental
environment and regular dental environment on children’s dental anxiety during restorations. |