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OptiSeDent: Sedation Protocols for Dental Care in Mental Disability
NCT02078336Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2013
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- UZ Leuven
- Modality
- Small Molecules
- Drugs
- midazolam
- Conditions
- intellectual disability (ID)
01
Overview
Phase 4, randomised trial of midazolam in intellectual disability (ID) (2 arms), sponsored by UZ Leuven. Primary endpoint: Level of cooperation of patient when receiving regular dental care. Started Dec 2013; status: active, not recruiting.
02
Design
2 arms- Study design
- Randomized
Midazolam
Midazolam 15mg Oral
Standard Care
Lorazepam or Cocktail (Diazepam+Biperiden+Droperidol+Atropine)
03
Who it enrols
Adult residents of nursing home 'het Gielsbos' with mental disability requiring sedation for dental care.
04
Endpoints
Primary
Level of cooperation of patient when receiving regular dental care
Secondary
Recording of vital parameters during regular dental care delivery
Level of patient comfort and possible side-effects after dental treatment session
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