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Can a Relaxing surrounding in Dental office Help Kids with Mental Retardation feel less Anxious

Evaluation of Sensory Adapted Dental Environment in Reducing Dental Anxiety in Children with Intellectual Disability - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084201
Enrollment
80
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F70- Mild intellectual disabilities

Interventions

Intervention1: 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.

Sponsors

Dr Shreya Tiwari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
Dental behavior using Frankl behavior rating scale.Timepoint: 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 treatmentTimepoint: 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.

Countries

India

Contacts

Public ContactDr Eswari R

Indira Gandhi Institute of Dental Sciences

arunasharma@igids.ac.in9444364251

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026