Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
NCT ID: NCT02078336
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2013-12-31
2025-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Midazolam
Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
Midazolam Mylan
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat
Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment
OR
Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment
\+ Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment
\+ Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment
\+ Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment
Lorazepam Mylan
Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
Interventions
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Midazolam Mylan
Lorazepam Mylan
Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Dominique Declerck
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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Katholieke Universiteit Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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2013-003991-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S55859
Identifier Type: -
Identifier Source: org_study_id
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