Dental Care for Disabled
Conditions
Brief summary
The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability. The primary objectives are: * To assess the level of cooperation during regular dental care using different procedural sedation protocols * To assess patient safety during regular dental care using different sedation protocols * To assess patient comfort and possible side-effects after regular dental care using different sedation protocols
Interventions
DRUGMidazolam Mylan
DRUGLorazepam Mylan
DRUGValium + Akineton + Dehydrobenzperidol + Atropine sulfate
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum age 18yrs * Patient resides at least 6 months in nursing home het Gielsbos. * Patient always gets a sedative protocol to make dental care delivery possible. * Informed consent was obtained from parent/guardian * No medical contra-indication for any of tested sedative protocols
Exclusion criteria
* Age under 18yrs * The patient is no resident of the nursing home het Gielsbos or lives there for less than 6 months. * No need for medicinal support during dental treatment * No informed consent was obtained by parents or the guardian of the patient. * Medical contra-indication for 1 of the sedative protocols
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of cooperation of patient when receiving regular dental care | Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recording of vital parameters during regular dental care delivery | 24 hrs | The measure is a composite of * recording of blood pressure * recording of pulse * recording of oxygen saturation |
| Level of patient comfort and possible side-effects after dental treatment session | 24 hrs | The measure of patient comfort and possible side-effects after dental treatment session is a composite of * changes in appetite * changes in toilet behavior * changes in level of consciousness * changes in level of concentration * changes in pattern of epileptic insults * changes in mood * changes in sleeping pattern * changes in level of motor skills |
Countries
Belgium
Outcome results
None listed