Comparison of Sensory-Adapted and Regular Dental Environments in Patients With Mild Intellectual Disability and Moderate Dental Anxiety (SADE vs RDE)

February 9, 2026 updated by: Oasi Research Institute-IRCCS

Comparison of Sensory-Adapted (SADE) and Regular Dental Environments (RDE) in Patients With Mild Intellectual Disability and Moderate Dental Anxiety

This study compared a sensory-adapted dental environment (SADE) with a regular dental environment (RDE) in 6-7-year-old children with mild intellectual disability and moderate dental anxiety. The objective was to determine which approach more effectively facilitates the completion of dental polishing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • EN
      • Troina, EN, Italy, 94018
        • Oasi Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 6-7; diagnosis of mild intellectual disability (DSM-5) Moderate anxiety (Corah DAS 9-12)
  • Informed consent from parents/legal guardians

Exclusion Criteria:

  • no or slight anxiety
  • high or severe anxiety
  • visual disorders
  • neuromuscular comorbidities interfering with cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensory adapted dental environment (SADE)
Other: SADE
Dental polishing performed in a sensory-adapted environment designed to reduce sensory stimuli.
Active Comparator: Regular dental environment (RDE)
Other: RDE
Dental polishing performed in a standard dental clinic environment without sensory adaptations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 25 minutes
Number of patients with completion of dental polishing under local anesthesia within 25 minutes (dichotomous: success vs. failure)
25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasi Research Institute-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RC-2794677___

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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