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Dental Care for Disabled | Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

Dental Care for Disabled research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dental Care for Disabled

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Midazolam Mylan

Drug:Lorazepam Mylan

Drug:Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MidazolamMidazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment

Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfatLorazepam 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

Study Status

Unknown status

Start Date: December 2013

Completed Date: August 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Level of cooperation of patient when receiving regular dental care

Secondary Outcome: Recording of vital parameters during regular dental care delivery

Study sponsors, principal investigator, and references

Principal Investigator: Dominique Declerck

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02078336

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