| CTRI Number |
CTRI/2025/07/091578 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Impact of Sensory Adapted Dental Environment On Anxiety |
|
Scientific Title of Study
|
TO ANALYZE THE IMPACT OF A SENSORY ADAPTED DENTAL ENVIRONMENT ON ANXIETY LEVEL OF PEDIATRIC PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rehan Ahmed Modi |
| Designation |
Post Graduate |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Mahesana
GUJARAT
384351
India |
| Phone |
09104142777 |
| Fax |
|
| Email |
rehanmodi3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba Fernandes |
| Designation |
Professor and Head of Department |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department no 8 , Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat
Mahesana
GUJARAT
384351
India |
| Phone |
7567622346 |
| Fax |
|
| Email |
vshobaf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rehan Ahmed Modi |
| Designation |
Post Graduate |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Mahesana
GUJARAT
384351
India |
| Phone |
09104142777 |
| Fax |
|
| Email |
rehanmodi3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital, Visnagar , Gujarat, India - 384315 |
|
|
Primary Sponsor
|
| Name |
Rehan Modi |
| Address |
Riyaz Manzil, opp Madina Appartment , Langawada street , Junagadh , Gujarat 362001 |
| Type of Sponsor |
Other [By Own] |
|
|
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 Rehan Ahmed Modi |
Narsinhbhai Patel Dental College and Hospital |
S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Mahesana
GUJARAT |
09104142777
rehanmodi3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Regular Dental Environment |
Dental procedure will be done in Regular Dental Environment till the treatment is being completed |
| Comparator Agent |
Sensory Adapted Dental Environment |
Sensory Adapted Dental Environment is specialized room with projection lights in which dental procedure will be done |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 5 and 9 years
Patients with class 1 caries bilaterally present
Patient who exhibit uncooperative behaviour |
|
| ExclusionCriteria |
| Details |
Children with special health care conditions
Patient with unrestorable tooth indicated for extraction
Patient with grossly decayed tooth structure |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the anxiety of pediatric patients under going dental procedure |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="28"
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)
|
01/08/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will be performed in patients visiting Department of Pediatric and Preventive Dentistry, NPDCH, Visnagar. 44 children will be included in the study according to selection criteria. Ethical clearance for carrying out the study will be obtained prior from the Institutional Ethics Committee (IEC) before starting the study. Study will be carried out only after written informed consent from each patient and parents. Each participant will be randomized to a sequence of two dental sitting on a 1 week recall schedule, one with a regular dental environment (RDE) and one with SADE. After selecting the patient, Intraoral Radiograph will be taken and then evaluate it with inclusion criteria. Caries will be removed using high speed airoter and burs. Cavity preparation will be done and restoration of prepared cavity will be done with Glass Ionomer Cement. Biomedical feedbacks such as Systolic, Diastolic blood pressure and Pulse rate will be monitored at baseline of treatment, interval of 5 min of treatment and at the end of the treatment in both the groups. Subjective assessment of Dental anxiety will be performed by WBFPRS (Wong-Baker Faces Pain Rating Scale) |