| CTRI Number |
CTRI/2025/04/084201 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Can a Relaxing surrounding in Dental office Help Kids with Mental Retardation feel less Anxious |
|
Scientific Title of Study
|
Evaluation of Sensory Adapted Dental Environment in Reducing Dental Anxiety in Children with Intellectual Disability - 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 |
Dr Shreya Tiwari |
| Designation |
Post graduate student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7760247736 |
| Fax |
|
| Email |
shreyatiwari777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Sharma |
| Designation |
Principal and Head of Department |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Principals office, 7th floor, Admin Block, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9444364251 |
| Fax |
|
| Email |
arunasharma@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eswari R |
| Designation |
Senior Lecturer |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9384361981 |
| Fax |
|
| Email |
eswarir@igids.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam 607402 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Tiwari |
| Address |
Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Shreya Tiwari |
Indira Gandhi Institute of Dental Sciences |
PG Clinic, Department of Pediatric and Preventive Dentistry, 1st floor, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, SBV Campus, Pillaiyarkuppam
Pondicherry
PONDICHERRY |
7760247736
shreyatiwari777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Dental Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensory Adapted Dental Environment (SADE) |
The SADE will be structured specifically where the sensory stimuli addressed will be visual, auditory, somato-sensory, olfactory and tactile. All direct overhead lighting will be removed, including the regular dental overhead lamp. The adapted lighting will consist of dimmed upward reflective fluorescent lighting. In addition, slow-moving, repetitive visual colour effects will be created. The dental operator will wear a head-mounted LED with narrow-spectrum light emitting diode source lamp directed into the patients mouth. Auditory and somato-sensory stimuli consisting of rhythmic music, will be played via speakers. Olfactory stimulus will include the placement of automatic air freshener. Tactile stimulus includes a butterfly wrap, which will be placed on the child throughout the dental procedure, covering him/her from the shoulders to the waist. This will help in providing a deep hugging pressure effect. Dental treatment will be done incorporating all these aspects in the Sensory Adapted Dental Environment. The duration of the intervention will be from the start of the dental treatment till the end of the dental treatment which may last upto 60 minutes based on the cooperation of the child during first visit. |
| Comparator Agent |
Typically developing (TD) children |
TD children will be treated in SADE or Regular dental environment (RDE). The exposure to SADE or RDE will be from the start of dental treatment till the end of dental treatment which may last upto 60 minutes depending on the cooperation of the child in the first dental visit. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children or adolescents from 3 to 14 years of age.
Children or adolescents with confirmed diagnosis of mild intellectual disability (ID), reporting for their first time in need of dental treatment.
Typically developing children or adolescents reporting for their first time in need of dental treatment.
Children or adolescents who have an accompanying parent/guardian who are able to read or understand the questionnaire in English or Tamil.
Children or adolescents having at least one carious lesion either in the primary or permanent molar
|
|
| ExclusionCriteria |
| Details |
Children or adolescents having disability such as cleft lip, significant motor impairments (cerebral palsy), or any known genetic, endocrine or metabolic dysfunction that would interfere with the physiological readings being taken.
Children or adolescents taking anticholinergic medication.
Typically developing (TD) children and adolescents with sibling diagnosed with ID.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety will be measured through physiologic parameters like pulse rate, blood pressure and temperature and scales like Venhams anxiety and cooperation scale and negative dental behavior checklist. |
Physiologic parameters and Venhams anxiety and cooperation scale will be measured at 2 points during the first visit at baseline and after completion of the dental treatment which may last upto 60 minutes based on the cooperation of the child. Negative dental behavior checklist will be measured at the first dental visit and will be assessed from the start of the treatment at baseline till the end of the treatment which may last upto 60 minutes based on the cooperation of the child. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dental behavior using Frankl behavior rating scale. |
Frankl behavior rating scale will be assessed in the first visit at baseline & after completion of the dental treatment which may last upto approximately 60 minutes depending upon the cooperation of the child. |
| Time taken for dental treatment |
Time taken for dental treatment will be assessed at first visit from the start of the dental treatment till the completion of the dental treatment which may last upto 60 minutes depending upon the cooperation of the child. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2025 |
| Date of Study Completion (India) |
22/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized, single blind, cluster trial evaluating the effectiveness of Sensory Adapted Dental Environment (SADE) in reducing the negative behaviour and physiological responses of dental anxiety in children and adolescents with mild intellectual disabilities (ID). Children with mild ID will be treated in SADE and regular dental environment (RDE). Dental treatment of typically developing (TD) children will also be done in SADE and RDE. Comparison will be done with TD children. Primary outcomes that will be assessed are physiologic response (pulse rate, blood pressure, temperature), Venham’s anxiety and cooperation scale, negative dental behavior checklist. Secondary outcomes included Frankl behavior rating scale, time taken for dental treatment. |