| CTRI Number |
CTRI/2024/04/065178 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Normal Dental Environment and Special Dental Environment on Anxiety of Children Undergoing Restorative Dental Treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of Sensory Adapted Dental Environment and Regular Dental Environment to Alleviate Anxiety in Children Undergoing Dental Treatment: A Randomized Control 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 Varunika V Sahai |
| Designation |
Post Graduate Student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9987963680 |
| Fax |
|
| Email |
varunikasahai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivayogi M Hugar |
| Designation |
Professor and Head |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9986436448 |
| Fax |
|
| Email |
drhugarsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varunika V Sahai |
| Designation |
Post Graduate Student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9987963680 |
| Fax |
|
| Email |
varunikasahai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Varunika V Sahai |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi |
| 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 Varunika V Sahai |
KLE VK Institute of Dental Sciences, Belagavi |
Department Number 6,
Department of Pediatric
and Preventive
Dentistry, KAHERs KLE
VK Institute of Dental
Sciences, JNMC
Campus, Nehru Nagar,
Belagavi
KARNATAKA
Belgaum
KARNATAKA |
9987963680
varunikasahai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee, KLE VK Institute of Dental Sciences, Belagavi |
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 |
| Comparator Agent |
Regular Dental Environment |
Evaluation of pre and post operative dental anxiety in children undergoing restorative dental treatment in regular dental environment. Treatment will be done in 45 minutes |
| Intervention |
Sensory Adapted Dental Environment |
Evaluation of pre and post operative anxiety in children undergoing restorative dental treatment in sensory adapted dental environment. Treatment will be done in 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 6-12 years of age.
2. Children visiting dental clinic for the first time.
3. Children with caries extending up to superficial dentin requiring Class 1 restoration in primary/ permanent molar teeth.
4. Children and/or parents who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs.
2. Children and/or Parents who are unwilling to participate in the study.
3. Parents of children who insist on being in the operatory shall be excluded from the study to avoid parental influence on child. |
|
|
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 |
| Measurement of preoperative and postoperative anxiety using Venhams Picture Scale and Pulse rate |
Baseline and Post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2024 |
| Date of Study Completion (India) |
27/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 Principal Investigator will perform the procedure under Standard Operating Protocols. The procedure will be carried out in 45 min for each patient in all the two groups. Parental consent and patient assent will be obtained. The patient will be first asked to sit comfortably on the dental chair. Case History of the patient and preoperative anxiety scores will be noted using Venham’s Picture Scale and Pulse Oximeter. The operator (principal investigator) will be then perform restorative treatment in sensory adapted and regular dental environment. Selected tooth will be isolated with rubber dam and class I cavity preparation using appropriate armamentarium will be done. After which the cavity will be restored using a suitable material. Post restorative instructions will be given. The sensory adapted dental environment is a specialized environment which will aim to activate all the 5 senses of human body to reduce dental anxiety. The setup will consist of moving ceiling light (visual stimulation), portable speaker with soothing music (auditory stimulation), air diffusers with aromatic oils (olfactory stimulation), stress balls or hugging toys (tactile stimulation) and flavoured runner dam sheets (gustatory stimulation). The regular setup will consist of no such specifications. |