New spatula could open mouths for better dental care in disabled patients
NCT ID NCT02818374
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a special spatula designed to help dentists examine the teeth of people with mental disabilities who have behavioral issues. The goal was to see if the spatula makes it easier and safer to look inside the mouth. Two hundred participants were included, and the study measured how much of the mouth could be seen and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral accessibility spatula (SAB)
- What this could lead to
- If it works, this spatula could make dental exams easier and safer for people with mental disabilities who struggle with oral care.
- What could go wrong
- This is a small, completed study with no phase designation, so results may not apply broadly. The device may not work for everyone or could cause discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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200 people
The number who actually took part.
- Started
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Mar 2016
- Finished
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Mar 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Mental disability patient with behavioural troubles known or noticed during the approach of hand for dental examination * Venham Scale score of 2 and higher, meaning opposing, after an approach toward the oral cavity * Information of the responsible person for the patient, if necessary, and followed by the dated signed informed consent Exclusion Criteria: * pregnant or nursing woman * lack of social security * people under guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHR METZ THIONVILLE- Bel-Air Hospital
Thionville, 57126, France
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CHR Metz-Thionville- Mercy Hospital
Metz, 57085, France
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CHRU Nancy
Nancy, 54000, France
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CHRU Strasbourg
Strasbourg, 67000, France
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CHU Dijon
Dijon, France
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Centre Hospitalier Emile Durkheim
Épinal, 88000, France
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Clinique Saint Francois
Haguenau, France