Mild Intellectual DisabilitySADE vs RDENCT07413016
Comparison of Sensory-Adapted and Regular Dental Environments in Patients With Mild Intellectual Disability and Moderate Dental Anxiety
A study testing SADE and RDE in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Mild Intellectual Disability
- What is being tested?
- SADE and RDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-7; diagnosis of mild intellectual disability (DSM-5) Moderate anxiety (Corah DAS 9-12)
- Informed consent from parents/legal guardians
Who cannot join
- no or slight anxiety
- high or severe anxiety
- visual disorders
- neuromuscular comorbidities interfering with cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mild Intellectual Disability
- Being tested
- SADE, RDE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADEOther
Dental polishing performed in a sensory-adapted environment designed to reduce sensory stimuli.
RDEOther
Dental polishing performed in a standard dental clinic environment without sensory adaptations.
| Study group | Role | What they receive |
|---|---|---|
| Sensory adapted dental environment (SADE) | Experimental | Not described Receives: Other: SADE |
| Regular dental environment (RDE) | Active comparator | Not described Receives: Other: RDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Number of patients with completion of dental polishing under local anesthesia within 25 minutes (dichotomous: success vs. failure)
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Feb 2026
- Primary completion25 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oasi Research Institute-IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413016
- Sponsor's protocol ID
- RC-2794677___
- Acronym
- SADE vs RDE
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37858057
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensory-Adapted (SADE) and Regular Dental Environments (RDE) in Patients With Mild Intellectual Disability and Moderate Dental Anxiety
- ClinicalTrials.gov ID
- NCT07413016
- Acronym / sponsor ID
- SADE vs RDE / RC-2794677___
- Conditions
- Mild Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oasi Research Institute-IRCCSUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory adapted dental environment (SADE) | Experimental | Other: SADE |
| Regular dental environment (RDE) | Active comparator | Other: RDE |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-7; diagnosis of mild intellectual disability (DSM-5) Moderate anxiety (Corah DAS 9-12)
- Informed consent from parents/legal guardians
Key exclusion criteria (4 listed)
- no or slight anxiety
- high or severe anxiety
- visual disorders
- neuromuscular comorbidities interfering with cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SADEDental polishing performed in a sensory-adapted environment designed to reduce sensory stimuli. | Other | Sensory adapted dental environment (SADE) |
| RDEDental polishing performed in a standard dental clinic environment without sensory adaptations. | Other | Regular dental environment (RDE) |
Primary outcome
Treatment success
Time frame: 25 minutes
Number of patients with completion of dental polishing under local anesthesia within 25 minutes (dichotomous: success vs. failure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 37858057Reynolds 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SADE and RDE in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.