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Completed
NCT02818374
The Oral Accessibility Spatula (Spatule SAB)
Conditions: Mental Handicap
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Centre Hospitalier Régional Metz-Thionville
Location: CHU Dijon Dijon
Summary
The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02818374). StuddyBuddy aggregates publicly available trial information.
