NCT07413016

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 29, 2026

Last Update Submit

February 9, 2026

Conditions

Mild Intellectual Disability

Outcome Measures

Primary Outcomes (1)

  • Treatment success

    Number of patients with completion of dental polishing under local anesthesia within 25 minutes (dichotomous: success vs. failure)

    25 minutes

Study Arms (2)

Sensory adapted dental environment (SADE)

EXPERIMENTAL
Other: SADE

Regular dental environment (RDE)

ACTIVE COMPARATOR
Other: RDE

Interventions

SADEOTHER

Dental polishing performed in a sensory-adapted environment designed to reduce sensory stimuli.

Sensory adapted dental environment (SADE)
RDEOTHER

Dental polishing performed in a standard dental clinic environment without sensory adaptations.

Regular dental environment (RDE)

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oasi Research Institute

Troina, EN, 94018, Italy

Location

Related Publications (1)

  • Reynolds K, Chimoriya R, Chandio N, Tracey D, Pradhan A, Fahey P, Stormon N, Arora A. Effectiveness of sensory adaptive dental environments to reduce psychophysiology responses of dental anxiety and support positive behaviours in children and young adults with intellectual and developmental disabilities: a systematic review and meta-analyses. BMC Oral Health. 2023 Oct 19;23(1):769. doi: 10.1186/s12903-023-03445-6.

    PMID: 37858057RESULT

Central Study Contacts

Antonio Fallea

CONTACT

+39 3381113255afallea@oasi.en.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 17, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-01

Locations

IT(1)