Mental Handicap Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)
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.
The oral examination of people with behavioural handicap seems to be difficult. Those
patients react with defensive reflexes which limit spontaneously the amplitude of their oral
cavity or prevent them to keep open their mouth for a sufficient time to process the
examination. This difficulty can be caused by various reasons: cerebral motor disability,
behavioral troubles or mental disability, and it affects people of all ages.
The current methods keeping open the mouth like wedges are often unsuitable for those
patients. Moreover, no other device exists or is described even in literature. An innovative
medical device has to be developed, in order to offer to disabled patients and the users or
dentists a comfort during the oral-dental examination.
The oral accessibility spatula, made out polypropylene plastic, is designed into two parts :
- a handle to hold the spatula by the user
- a thin plastic surface introduced into the mouth, which is dull with a round edge and
has holes on the sides to lock the spatula between the upper and lower teeth.
Primary objective :
To evaluate the buccal access during a first oral-dental examination without and then with
the oral accessibility spatula (SAB).
Secondary objective :
To evaluate the safe use of the SAB To evaluate the tolerance of the exam without, and then
with the SAB
Primary endpoint :
Visibility and dental examination of incisor-canine sectors, premolars and molars using a
probe, assessed by an oral accessibility score determined based on intra oral accessible
areas with and without oral accessibility Spatula device
Secondary endpoints :
The safety of the spatula will be assessed by analyzing the reported adverse effects and
their relative frequency The dental exam tolerance evaluation; with and without Oral
Accessibility .Spatula
Methodology :
Multi-center interventional prospective study, open-label Only one medical check per patient
Procedures :
Any patient with a behavioral handicap, and who consults with dentist for a preventive
check-up or a oral-dental curative act, is examined by an inclusion operator who checks the
inclusion or non-inclusion criteria, and especially the behavior with Venham Scale (only
patients with a score of 2 and higher, meaning opposing, after an approach toward the oral
cavity are included).
The oral accessibility score of each eligible patient is performed twice, without the SAB
first, and then with the SAB.
The incidents and/or potential injuries are reported from a standardized grid. Venham scale
score is measured a second time during the oral-dental examination without or with the
spatula.
Patients number :
Without the SAB, the rate of patients with an oral accessibility score of at least level 8 is
20%.
The protocol forecasts hypothetically a 20% highering of this rate after the use of SAB (so
40% of patients with a score of 8 and higher). With a total staff of 140 patients, this
hypothesis is validated with an α risk set at 5% and a statistical power at 90%. 200 patients
are expected in order to take into account a potential center effect and a potential
investigator effect, and a study output rate of 10%.
Trial Time :
Only one medical check per patient, so the total duration goes with the inclusion period of
18 months.
Expected study start : first semester of 2016 End of inclusion : second semester of 2017 End
of study : second semester of 2017
Statistical Analysis :
The major analysis will be the comparison of the oral accessibility scores during the
examination with or without the SAB. Each patient will be his own control, and the
examinations always will be performed without the SAB in first, and secondly with the SAB, by
the same dental surgeon.
Expected Benefits :
The expected result is the proof of a best examination quality with no risk for the patient.
The major prospect is the availability of the SAB to dental surgeons to improve the
therapeutic indications and the quality of examinations, then to parents, carers and
caregivers, in order to make possible and easier the application of a oral-dental health
suitable for handicapped or disabled people.
So, the expected benefits are :
- early diagnostic of the oral-dental diseases
- improved efficiency of the tooth care
- reduction of the use of general anesthesia for oral examinations
- help for tooth washing in order to improve significantly the oral-dental healthy level
- improved prevention by the availability of the spatula to parents, carers and
physicians.
Quality Assurance Plan :
Data will be recorded in a Paper Case Report from medical records. The patients will undergo
only one medical examination for the study. No follow-up is expected.
;
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